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Eltek Supplier Assessment

la
Quality Mgmt. ### ######
100.00%
Environmental Mgnt ### ######
Labour & Human Rights NA ######
90.00%
Health & Safety ### ######
Product Planning ### ######
Supplier Management
80.00% ### ######
Manufacturing ### ######
Quality Control
70.00% ### ######
Traceability (ETS) #########
Commodity Specific
60.00% ### ######
Total ### ######

50.00%

40.00%

30.00%

20.00%

10.00%

0.00%

Sustainability & CSR

Labour & Product


Quality Environmental Human rights, Supplier Quality Traceability Commodity
Section Planning Manufacturing Overall
Management Management Fair business Health & Safety management Control (ETS) Specific
NPI;DPR;PM)
& Etihics (OHSAS18000)
(SA8000,
ISO26000)

Score NA NA NA NA NA NA NA NA NA NA #DIV/0!
Points for
75 75 75 75 75 75 75 75 75 75 75
Green

Remarks:

Supplier: 0 Audit Date: 0


Systems unable to meet
< 60 requirements (High Risk)
Address: 0
0
0 Systems acceptable, but
³ 60, requires action plan
City/State 0 Country < 75 (Intermediate Risk)

0
Eltek Representative(s):
Systems meet or exceed
³ 75 requirements. (Minimum Risk)

Sign-Off APPROVAL AUDIT: Eltek Lead Auditor Title/Postion Date

Sign-off ACTION APPROVAL: Eltek Lead Auditor

Sign-Off FOLLOW UP AUDIT: Eltek Lead Auditor

Date: 2018-04-04 Cover Process Owner/Department:


Revision: 8 R. Langtangen /DirectorSupplier Quality
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page1 of 51
Eltek Supplier Assessment SUPPLIER FACILITY AUDIT

Supplier Name: December 30, 1899 Audit Date: 30-Dec-99 Systems unable to meet Eltek
< 60
requirements
³ 60, Systems acceptable, but require
< 75 action plan
Systems meet or exceed
³ 75
requirements.

1) QUALITY MANAGEMENT 2) ENVIRONMENTAL MANAGEMENT 3) Sustianability & CSR (SA8000, ISO26000)

Maximum Points Available: 0.00 Maximum Points Available: 0.00 Maximum Points Available: 0.00
Section Available Score Section Available Score Section Available Score
1.1 Quality Management System 0 0 #DIV/0!

2.1 Environmental Management 0 0 #DIV/0!

3.1 SA8000, ISO26000 0 0 #DIV/0!

1.2 Quality Audits 0 0 #DIV/0!

2.2 RoHS & WEEE 0 0 #DIV/0!

3.2 Fair business and ethics 0 0 #DIV/0!

1.3 Document Management 0 0 #DIV/0!

2.3 Environmental Audits 0 0 #DIV/0!

Total Points: 0.00


1.4 Resource Management 0 0 #DIV/0!

Total Points: 0.00 Section Score: NA


Total Points: 0.00 Section Score: NA
Section Score: NA

4) Health & Safety (OHSAS 18000) 5) PRODUCT PLANNING (NPI, DPR) 6. SUPPLIER MANAGEMENT
Maximum Points Available: 0.00 Maximum Points Available: 0.00 Maximum Points Available: 0.00
Section Available Score Section Available Score Section Available Score
4.1 OHSAS18001 0 0 #DIV/0!

5.1 Product Realization 0 0 #DIV/0!

6.1 Supply Chain Management 0 0 #DIV/0!

4.2 Security 0 0 #DIV/0!

5.2 Design & Development 0 0 #DIV/0!

6.2 Incoming Inspection, Layout 0 0 #DIV/0!

Total Points: 0.00 5.3 Advanced Quality Planning 0 0 #DIV/0!

Total Points: 0.00


Section Score: NA Total Score: 0.00 Section Score: NA
Section Score: NA

7) MANUFACTURING 8) QUALITY CONTROL 9) COMMODITY SPECIFIC


Maximum Points Available: 0.00 Maximum Points Available: 0.00 Maximum Points Available: 0.00
Section Available Score Section Available Score Section Available Score
7.1 Identification and Traceability 0 0 #DIV/0!

8.1 Quality Control 0 0 #DIV/0!

20.010 Die Cast 0 0 #DIV/0!

7.2 Production Control 0 0 #DIV/0!

8.2 Statistical Process Control 0 0 #DIV/0!

20.020 Plastics 0 0 #DIV/0!

7.3 Manufacturing Monitoring 0 0 #DIV/0!

8.3 Control of Monitoring Devices 0 0 #DIV/0!

20.030 Magnetics 0 0 #DIV/0!

7.4 Inventory and Storage 0 0 #DIV/0!

8.4 Non-Conforming Product 0 0 #DIV/0!

20.040 Sheet metal 0 0 #DIV/0!

7.5 Preventive Maintenance 0 0 #DIV/0!

8.5 Improvement Processes 0 0 #DIV/0!

20.050 PCB 0 0 #DIV/0!

Total Points: 0.00 Total Points: 0.00 20.070 PCBA 0 0 #DIV/0!

Section Score: NA Section Score: NA 20.080 Assembly 0 0 #DIV/0!

20.100 Forwarder 0 0 #DIV/0!

20.200 Logistics 0 0 #DIV/0!

22.00 Lithium batteries 0 0


Total Score: 0.00
Section Score: NA

10) TRACEABILITY
Maximum Points Available: 0.00
Section Available Score
9.1 General 0 0 #DIV/0!

9.2 Product data input 0 0 #DIV/0!

9.3 Label printing 0 0 #DIV/0!

9.4 Production 0 0 #DIV/0!

9.5 Ware house shipping 0 0 #DIV/0!

9.6 Service repair 0 0 #DIV/0!

9.7 Tracing 0 0 #DIV/0!

9.8 ETS Reporter 0 0 #DIV/0!

0.00 Total Points: 0.00


0.00 Section Score: NA
#DIV/0!

Date: 2016-03-02 479476151.xlsx; Score-Summary Process Owner / Department:


Revision: 7 R. Langtangen / Quality Director SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 2 of 51
Eltek Supplier Assessment SUPPLIER FACILITY AUDIT
Supplier Name: 0 Audit Date: 0 Systems unable to meet Eltek
< 60
requirements (High Risk)
³ 60, Systems acceptable, but require action
< 75 plan (Intermediate Risk)
Systems meet or exceed requirements.
³ 75
(Minimum Risk)

1. QUALITY MANAGEMENT (25%)


1.1 Quality Management System Number of Total Awarded
1.11 1.12 1.13 Questions Points Points

0 0.00 #DIV/0!

1.2 Quality Audits Number of Total Awarded


1.21 1.22 Questions Points Points

0 0.00 #DIV/0!

1.3 Document Management


Number of Total Awarded
1.31 1.32 1.33 Questions Points Points

0 0.00 #DIV/0!

1.4 Resource Management Number of Total Awarded


1.41 1.42 1.43 Questions Points Points

0 0.00 #DIV/0!

2 ENVIRONMENTAL MANAGEMENT (15%)


2.1 Environmental Managment System Number of Total Awarded
2.11 2.12 2.13 2.14 Questions Points Points

0 0.00 #DIV/0!

2.2 RoHS & WEEE Number of Total Awarded


2.21 2.22 2.23 2.24 2.25 2.26 2.27 Questions Points Points

0 0.00 #DIV/0!

2.3 Environmental Audits Number of Total Awarded


2.31 2.32 2.33 2.34 Questions Points Points

0 0.00 #DIV/0!

3.0 Labour & Human Rights, Fair business & Ethics (SA8000, ISO26000)
3,1 SA 8000 Number of Total Awarded
3.11 3.12 3.13 3.14 3.15 3.16 3.17 3.18 Questions Points Points

0 0.00 #DIV/0!

3,2 Corporat Social Responsibility (CSR) Number of Total Awarded


3.21 3,22 3,23 3,24 Questions Points Points

0 0.00 #DIV/0!

Date: 2016-01-04 479476151.xlsx; Score-Detail Process Owner/Department:


Revision: F R. Langtangen / Quality Director SQM
Doc No: GFORM_270
Page 3 of 51
Eltek Supplier Assessment SUPPLIER FACILITY AUDIT
Supplier Name: 0 Audit Date: 0 Systems unable to meet Eltek
< 60
requirements (High Risk)
³ 60, Systems acceptable, but require action
< 75 plan (Intermediate Risk)
Systems meet or exceed requirements.
³ 75
(Minimum Risk)

4.0 OHSAS18001, SECURITY (15%)


4.1 OHSAS 18001 Number of Total Awarded
4.11 4.12 4.13 4.14 4.15 4.16 Questions Points Points

0 0.00 #DIV/0!

4.2 Security Number of Total Awarded


4.21 4.22 4.23 4.24 4.25 Questions Points Points

0 0.00 #DIV/0!
5. Product Planning (NPI,DPR)
5.1. Product Realization
Number of Total Awarded
5.11 5.12 5.13 5.14 Questions Points Points

0 0.00 #DIV/0!

5.2 Design & Development Number of Total Awarded


5.21 5.22 5.23 5.24 5.25 5.26 5.27 5.28 Questions Points Points
0 0.00 #DIV/0!

5.3 Advanced Quality Planning Number of Total Awarded


5.31 5.32 5.33 5.34 5.35 5.36 Questions Points Points

0 0.00 #DIV/0!

7. MANUFACTURING
7.1 Identification & traceability Number of Total Awarded
7.11 7.12 7.13 7.14 7.15 7.16 Questions Points Points
0 0.00 #DIV/0!

7.2 Production control Number of Total Awarded


7.21 7.22 7.23 Questions Points Points

0 0.00 #DIV/0!

7.3 Manufacturing Monitoring & measurement Number of Total Awarded


7.31 7.32 7.33 7.34 7.35 7.36 7.37 7.38 7.39 7.310 7.311 7.312 Questions Points Points

0 0.00 #DIV/0!

7.4 Inventory & Storage Number of Total Awarded


7.41 7.42 7.43 7.44 7.45 Questions Points Points
0 0.00 #DIV/0!
7.5 Preventive Maintenance Number of Total Awarded
7.51 7.52 7.53 7.54 7.55 7.56 7.57 7.58 7.59 7.60 Questions Points Points
0 0.00 #DIV/0!

8. QUALITY CONTROL
8.1. Quality Control Number of Total Awarded
8.11 8.12 8.13 8.14 Questions Points Points

0 0.00 #DIV/0!

8.2 Statistical Process Control Number of Total Awarded


8.21 8.22 8.23 8.24 8.25 8.26 8.27 8.28 Questions Points Points

0 0.00 #DIV/0!

8.3 Control of Monitoring devices Number of Total Awarded


8.31 Questions Points Points
0 0.00 #DIV/0!

8.4. Non-Conforming Product Number of Total Awarded


8.41 8.42 8.43 8.44 8.45 8.46 Questions Points Points

0 0.00 #DIV/0!

8.5 Improvement Processes Number of Total Awarded


8.51 8.52 8.53 8.54 8.55 8.56 Questions Points Points
0 0.00 #DIV/0!

6. SUPPLIER MANAGEMENT
6.1 Supply Chain Management Number of Total Awarded
Questions Points Points
Date: 2016-01-04 479476151.xlsx; Score-Detail Process Owner/Department:
Revision: F R. Langtangen / Quality Director SQM
Doc No: GFORM_270
Page 4 of 51
Eltek Supplier Assessment SUPPLIER FACILITY AUDIT
Supplier Name: 0 Audit Date: 0 Systems unable to meet Eltek
< 60
requirements (High Risk)
³ 60, Systems acceptable, but require action
< 75 plan (Intermediate Risk)
Systems meet or exceed requirements.
³ 75
(Minimum Risk)
Number of Total Awarded
6.11 6.12 6.13 6.14 6.15 6.16 Questions Points Points

0 0.00 #DIV/0!
6.2 Incoming Inspection Number of Total Awarded
6.21 6.22 6.23 6.24 Questions Points Points

0 0.00 #DIV/0!

Date: 2016-01-04 479476151.xlsx; Score-Detail Process Owner/Department:


Revision: F R. Langtangen / Quality Director SQM
Doc No: GFORM_270
Page 5 of 51
Eltek Supplier Assessment SUPPLIER FACILITY AUDIT
Supplier Name: 0 Audit Date: 0 Systems unable to meet Eltek
< 60
requirements (High Risk)
³ 60, Systems acceptable, but require action
< 75 plan (Intermediate Risk)
Systems meet or exceed requirements.
³ 75
(Minimum Risk)

COMMODITY SPECIFIC (5%)

20.01 Die Cast Number of Total Awarded


.011 .012 .013 .014 .015 .016 .017 .018 Questions Points Points

0 0.00 #DIV/0!

20.02 Plastics
Number of Total Awarded
.021 .022 .023 .024 .025 .026 .027 .028 Questions Points Points

0 0.00 #DIV/0!

20.100 Forwarder Number of Total Awarded


.110. .120 .130 .140 Questions Points Points

0 0.00 #DIV/0!

Magnetics Number of Total Awarded


20.031 20.032 20.033 20.034 20.035 Questions Points Points

0 0.00 #DIV/0!

20.04 Sheet metal Number of Total Awarded


.041 .042 .043 .044 .045 .046 Questions Points Points

0 0.00 #DIV/0!

20.05 PCB
Number of Total Awarded
.051 .052 .053 .054 .055 .056 .057 .058 .059 .060 Questions Points Points

0 0 #DIV/0!

20.07 PCBA Number of Total Awarded


.071 .072 .073 .074 .075 .076 .077 .078 .079 .080 .081 .082 .083 Questions Points Points

0 0 #DIV/0!

Date: 2016-01-04 479476151.xlsx; Score-Detail Process Owner/Department:


Revision: F R. Langtangen / Quality Director SQM
Doc No: GFORM_270
Page 6 of 51
Eltek Supplier Asessment
SUPPLIER FACILITIY AUDIT FINDINGS SUMMARY
Supplier Name: Supplier Representatives: Audit Date: SEVERITY No of Findings

Address: No Compliance/major Issues related to required standards and/or


Very Good Performance MAJOR agreements signed by Eltek & Supplier.
Knowledge, documentation, evidence References to requirements needed.
4 present and easy retriveable
Well implemented
City/State/Zip: Acceptable Performance
Knowledge, documentation, evidence Partial Compliance/Marginally acceptable with action plan. Issues related to
3 present and retriveable. MINOR required standards and/or agreements signed by Eltek & Supplier.
Some Deficensies in implementation References to requirements needed.

Country:
Condtional acceptance
Minor Deficencies in Knowledge,
documentation, evidence and/or
2 Implementation
Action Plan required to meet acceptable
level of performance Findings related to issues not covered by requirements required by Eltek or
Eltek Representatives: If the finding can't be referred to in agreements/requirements. Can be used
OBSERVATION
Unacceptable Performance for Improvement suggestions as well.
Significant Deficencies in Knowledge, NO references to requirements needed.
1 documentation, evidence and/or
Implementation

0 No Compliance, system not evident

1.1 Quality Management Systems Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

• Quality Manual
1.11 Does the organization have a certified quality system? • Procedures
• Certificates Manual to ISO9001/TS 16949 or
Mandatory
conversion matrix.
Requirement: Eltek GPRO_10

IIs a quality policy established and communicated Quality policy approved by CEO.
throughout the organization? lQuality Policy
1.12
lQuality Operating Correlation between Quality policy and
Requirement: ISO 9001 -2015 5.2.1 System Quality objectives
ISO 9001 - 2008 5.3

Does the organization compare trends in quality and


* Comparison of trends to goals.
operational performance towards goals and
* Actions to trend analysis.
1.13 objectives? l Quality Metrics/KPI
* Prioritization of action.
Mandatory Is Top management a part of the review? with action plans and
* Management review meeting
follow up
minutes,
Requirement: ISO 9001 - 2015 6,2 & 9
* Action Plans and follow-up
ISO 9001 - 2008 5.4.1 & 8

1.2 Quality Audits Audit Worksheet Action Plan


No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed
Are Internal audits planned, conducted and carried out Audits planned
1.21 according to Audit plan ? Audits conducted.
Mandatory l Audit plan Audit actions closed and verified.
Requirement: ISO 9001 -2015 9.2 & 10
ISO 9001 - 2008 8.2.1

Are audits results brought to the attention of personnel


in charge of the audited area ? Do records indicate
1.22 Time between implementation of action
review and verification of the effectivenes of action(s) ?
Mandatory * Audit reports and time for closing. Has it been time to
verify effectivenes of implemented action?
Requirement: ISO 9001 -2015 9.2 & 10
ISO 9001 - 2008 8.2.1

1.3 Document Management Action Plan


No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed
Has the organization established a document control Document control master list or equivalent.
procedure,
Availability of documents in various
a) to approve documents before release? locations.
b) to ensure changes and current document revision
are clearly identified? Process for notification/distribution of
c) to assure relevant documents are available at point documents from internal and external
of use? origins.
d) to assure documents remain legible and
l Document Control
1.31 identifiable?
Procedure
e) to ensure documents of external origin are identified
and their distribution controlled?
f) to prevent unintended use of obsolete documents,

Requirement: ISO 9001 - 2015 7.5


ISO 9001 - 2008 4.2.3

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 7 of 51
Eltek Supplier Asessment
l Process for notification/distribution of
customer engineering
Does the organization have a process to assure timely
standards/specifications.
review, distribution and implementation of all customer
Customer and Regional l Process for implementation of customer
engineering standards/specifications and changes?
Standards/specs initiated change.
1,32 Does this take place in a timely manner?
l Document changes triggered by
Mandatory
Customer change engineering changes.
Requirement: ISO 9001 - 2015 8.3.6 & 8.5.6
notifications l Records of engineering changes
ISO 9001 - 2008 7.3.7
implemented.
Eltek GPRO_306

Has the organization established a documented l Quality Management l Quality Manual according to ISO/TS
procedure to define the controls needed for the System 16949:2002./ISO 9001
identification, storage, protection, retrieval, retention l Record maintenance l Defined record retention time compared
time and disposition of records? system to customer/regulatory requirements.
1.33
Requirement: ISO 9001 - 2015 7.5.3
ISO 9001 - 2008 4.2.4

1.4 Resource Management Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Does the organization l Job Description l Training records complementing the type
a) determine the necessary competence of person(s) l Training records of work that the personnel perform on the
doing work under its control that affects the l Personnel records product.
performance and effectiveness of the quality l Training Plan l Personnel records.
management system; l Interviews with personnel.
b) ensure that these persons are competent on the
basis of appropriate education, training, or experience;
c) where applicable, take actions to acquire the
1.41 necessary competence, and evaluate the effectiveness
of the actions taken;
d) retain appropriate documented information as
evidence of competence.

Requirement: ISO 9001 - 2015 7.1 & 7.2


ISO 9001 - 2008 6

Does the organisation detremine, provide and maintain


the infrastructure for the operation of it's processes and
to achieve conformity of products and services ?
Infrastructrure can include ;
a) Building(s) and associated utilities
b) Equipment incl hardware and software
1.42 c) Transportation resources
d) Information and communication technology

Requirement: ISO 9001 - 2015 7.1.3


ISO 9001 - 2008 6.3

Does the organisation provide and maintain the work Verification thru walk about in the premises
environment necessary to achieve conformity of
products and services ? Interviews with personnel.

a) Social (e.g. non-discrimunatory, calm)


b) Psychological (e.g. stress-reducing, burn-out
1.43 preventiv, emotionally protective)
Mandatory c) Physical (e.g. temperature, heat, humidity, light,
airflow, hygiene, noise)

Requirement: ISO 9001 - 2015 7.1.4


ISO 9001 - 2008 6.4

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 8 of 51
Eltek Supplier Asessment

2. Environmental Management Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Does the organization have a certified Environmental l Environmental Manual l Manual to ISO14001.
system? l Procedures
2.11 l Process Maps
Requirement: Eltek GPRO_10

Has the organization done an analysis of its lAspect & impact lContent of analysis, last review and
environmental aspects & impacts ? analysis. update of analysis

NOTE:
Environmental aspect - element of the organisations
activities, products or services that can interact with the
environment.(both threats and opportunities)
2.12
Environmental impact -
any changes to the environment whether adverse or
benificial, wholly or partially resulting from the aspects

Requirement: ISO 14001 -2015 6.1.2


ISO 14001 - 2004 4.3

Has the organization established environmental


objectives and targets at relevant functions and levels
* Comparison of trends to goals.
within the organization?
* Actions to trend analysis.
2.13
* Prioritization of action.
Mandatory Are the environmental objects and targets maintained l Environmental Metrics
* Management review meeting
and up-to-date?
minutes,
* Action Plans and follow-up
Requirement: ISO 14001 - 2015 6.2
ISO 14001 - 2004 4.3.3

Has the organization as a minimum established


Wallboards
2.14 waste mangement system incl segregation of waste?
lPhysical eveidence as Bins
Mandatory
bins, etc Agreements with 3'rd part
Local Government reports
Requirement: ISO 14001 3.2.7
2.2 RoHS & WEE Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Is the organization compliant with RoHS II Directive *Are components registered in


2011/65/EU? Bomcheck/Silicon expert with RoHS II
Declaration of Compliance documents in
Ref: RoHS II Directive 2011/65/EU (replaced RoHS I lRoHS complience databases?
2,21 from jan3, 2013)
declerations
Mandatory *Are testing done to evaluate the 6
Requitement: Eltek GPRO_018, GPRO_075, substances in RoHS2? (EN62321:2009)
GFORM_299, GFORM_316, GFORM_317 XRF
In house? / External lab?

Is the organization compliant with WEEE , directive


2012/19/EU? If applicaple, (electronic equipment)
2.22 Compliance documents Decission making documents as reports,
Ref: directive 2012/19/EU minutes of meeting etc.

Does the organization have Harmonized standard EN


50 581 (Technical File) available for the assembled Knowledge about EN50581
2.23 product? Techincal file
Techical file for actual assembly
i. (Module A of decision 768/2008/EC)
Does the organization have WEEE document of the If applicable ( electronic
assembled product ? equipment) WEEE
documents,
2.24 WEEE documents for assembled parts
Requirement: If Eltek products, Eltek is responsible

Is the organization compliant with REACH Directive? If applicable


( Manufacturing, sales
Ref: Regulation of the EU: (EC) No. 1907/2006 into Europe only) -
• Went into effect on 1st June 2007 Official registrations with
2.25 Chemical/Substance amount per year
the European Chemicals
Agency (ECHA).

Does the supplier organization comply with the "Black


& Grey list"
2,26 (Banned and Restricted Substances) Black and Grey list
Existens of a Black and Grey list
Mandatory
Requirement: Eltek GPRO_76

Is there any proof of how the organization ensures that


they are meeting the obligations under ROHS? If applicaple, (electronic equipment)
2,27
E.g if bought from outside the EU ? Procedure/instruction Decission making documents as reports,
Mandatory
minutes of meeting etc.
Requirement: GFORM_316 Appendix 4

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 9 of 51
Eltek Supplier Asessment
2.3 Environmental audits Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Are Internal audits planned, conducted and carried out


according to Audit plan ?
2.31 Audits planned
Mandatory l Audit plan Audits done.
Requirement: ISO 14001 - 2015 9.2
ISO 14001 - 2004 4.5.5.

Are audits results brought to the attention of personnel


in charge of the audited area ? Do records indicate
review and verification of the effectivenes of action(s) ?
2.32 Time between implementation of action
Mandatory Requirement. ISO 14001 - 2015 9.2.2, 10.2 & 10.3 * Audit reports and time for closing. Has it been time to
ISO 14001 - 2004 4.5.5 verify effectivenes of implemented action?

Are an audit programme planned and taking into


consideration the importance of the processes and
areas to be audited as well as the results of previous
Criteria
audits ?
Scope
2.33 Audit plan
Method
The audit criteria, scope, frequency and methods shall Audit reports
Impartiality
be defined.

Requirement. ISO 14001 - 2015 9.2.2, 10.2 & 10.3


ISO 14001 - 2004 4.5.5

Does the Audit programme identify potential


emergency situations and potential accidents that can
2.34 have impact on the environment ? Audit plan Existence of procedure
Procedure Part of auditplan
Requirement: ISO 14001 - 2015 8.2
ISO 14001 - 2004 4.4.7

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 10 of 51
Eltek Supplier Asessment

3.0 Labour & Human Rights, Fair business & Ethics (SA8000, ISO26000) Audit Worksheet Action Plan

3.1 Labour & Human Rights

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

a) Has the organization established a policy and


implemented procedures for the company's social
accountability/responsility?
b) Is the policy and procedures according to SA 8000?
3,11 c) Is the company certified to SA 8000? Policies and procedures translated in major
Policy, Certificate
Mandatory languages spoken by employees
Requirement: Eltek GPOL_31
SA8000

Does the company have a policy that supports


international human rights or with reference to Does the policy cover employees' health
3.12
National laws ? and safety, working conditions, labor
Mandatory Policy/Procedure
relations, child and forced labor, career
Requirement: Eltek GPOL_31 management, discrimination?
SA8000
Are the employees free to join or not to join trade
unions or similar external organizations, and to
3.13 bargain collectively?
Is this right fully granted? Any restrictions?
Mandatory Policy/Procedure
Requirement: Eltek GPOL_31
SA8000

a) Do the employees have contracts according to


national laws and regulations?
b) Are the employees free to leave their employment
after reasonable notice and not bound by bonding
arrangements? (I.e. leave deposits of money or other Does the organization fullfil local law or
3.14
belongings with the employer) Contracts (examples) regulations?
Mandatory
Employee files Check employee files for contracts, money,
Requirement: Eltek GPOL_31 passport, deposits, etc
SA8000

a) Does the company comply with international


standards for minimum age of employment? (15 years)
?

b) Does the company have a policy for child labor,


considering the best of the child?
Employee records
3.15 c) Does the company comply to the United Nations Engagements or measures taken to
Policy
Mandatory Convention of the Rights of the child for persons under prevent or eradicate child or forced labor?
Random checks of
18, regarding hazardous work or work that is
persons under 18
inconsistent with the child's development?

Requirement: Eltek GPOL_31


SA8000

a) Has the company defined employment conditions


and do the employees understand their contract?
b) Are payment and terms fair and reasonable and
comply with with national laws and industry standards?
c) Do working hours comply with national laws ? Official measures to compensate a typical
d) Are dormitory, canteen & kitchen (where available) working hours?
3.16 as well as workers toilet/rest room in an acceptable Rest periods or vacations in accordance
Contracts (examples)
Mandatory conditions ? (cleanliness, smell etc) with legal requirements?
Working hours records
working hours, time off, wages and
Requirement: Eltek GFORM_299 compensations, disciplinary practices,
SA8000 forced labour,

a) Does the company have a policy that ensures the


employees to be treated with respect and dignity?
b) Does the company state rules or policies to avoid
physical and verbal punishment? Public commitment to avoid discrimination
c) Does the company have a policy to prohibit (e.g. color, race, gender, religion, ethnic,
3.17
discrimination? social)
Mandatory Policy/Procedure
Proactive measures to avoid discrimination
Requirement: Eltek GFORM_299 during recruitment phase (please specify)
SA8000

Does the company require their suppliers to meet


SA8000 or Code of Conduct requirements similar to
3.18 Requirement included in
those mentioned above ? Policy
contract/agreement?
Requirement : Observation only

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 11 of 51
Eltek Supplier Asessment
3.2 Fair business and ethics Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Communication of Code of Ethics policy to


all employees
Has the organization formalized its policy/ policies on
fair business practices? Policy/policies Communication of Code of Ethics business
3.21
Communication partners (e.g. suppliers)
Requirement: Eltek GPOL_31

Does the company have a policy that states clearly that


bribery or improper payments to or from employees or
3,22 organizations are prohibited?
Policy/Procedure Policy statement
Mandatory
Requirement: Eltek GPOL_31

Signature acknowledgement of anti-


corruption policy required for all concerned
employees
Structured mechanisms to deal with policy
Are there actions in place against corruption, bribery violations (e.g. potential sanctions)
3,23 and anti-competitive practices? Signed documents. Secure communication channel for
Mandatory Policy employees to seek advice or voice
Requirement: Eltek GPOL_31 concerns
Training program on anti-corruption and
anti-competitive practices

Does the company require their suppliers to meet


3,24 requirements similar to those mentioned above ? Supplier agreements
Signed agreements
Mandatory Policy&Procedures
Requirement : Observation only

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 12 of 51
Eltek Supplier Asessment
4. Health & Safety (OHSAS 18000) & Security Audit Worksheet Action Plan

4.1 OHSAS18001

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

a) Has the organization established and communicated


policies for health and safety?

b) Has the organization established, documented and


4,11 implemented procedures for health and safety? Policy Policies and procedures translated in major
Mandatory Procedures languages spoken by employees
Requirement: GPRO_10, GFORM_316 19.0
If certified: OHSAS 18001 4.2

Are the policy and procedures according to OHSAS


18001?
Policy a) policy
4.12
Is the company certified according to OHSAS 18001? Certificates b) certificate

Requirement: Observation only"

Health and safety risk assessment and


responsibilities defined
Has the organization established,
documented and implemented Provision of protective equipment to all
procedures for; impacted employees

a) hazard identification, Specific procedures for handling of


b) risk assessment, chemicals or hazardous substances
4,13 c) determination of necessary controls,
Documented procedures Training of all relevant employees on
Mandatory d) identifying and accessing the
legal and other health and safety health and safety
requirements that are applicable
to it??

Requirement: GPRO_10, GFORM_316 19.0


If certified: OHSAS 18001 4.3.1

Has the organization established procedures for


identifying emergency situations and to respond to
such emergency situations? Procedures translated in major languages
4.14
spoken by employees
Mandatory Documented procedures
Requirement. GFORM_316 14.1 Procedures easily available in an
If cerified: OHSAS 180011 4.4.7 emergency situation

a) Has the organization established procedures for


monitoring and measuring health and safety
performance on a regular basis?
b) Has the organization established procedures for
4.15 KPIs and measurements
recording, investigating and analysing incidents?
Mandatory Documented procedures Incident handling; root cause analys,
actions, verification
Requirement: GFORM_316 19.0
If certified: OHSAS 18001 4.5

a) Does the organization conduct internal audits of the


health and safety management system?
b) Does top management review the organization's
health and safety management system? Audit plans
4,16 Audit plans
Audit reports
Mandatory Audit reports
Requirement: Observation if not certified Management review
If certified: OHSAS 18001 4.5.5

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 13 of 51
Eltek Supplier Asessment
4.2 Security Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Has the organization established a production recovery


4.21 plan including timelines?
Up to date Production Timeframes
Mandatory
Recovery plan
Requirement: GFORM_316 4.7
GFORM_317 Article 19
Has the organization established a confidentiality
agreements policy and confidentiality agreements with
Signed agreements.
4,22 its employees? Policy/procedure
If customer documents are re-used in copy
Mandatory Agreements
machine
Requirement: GFORM_316 16.0
GFORM_317 Article 16

Has the organization established liability insurance?


4.23 (Covering damage on 3'rd parts property)
Mandatory Insurance document Value, coverage
Requirement: GFORM_316 11.3 & 15.0
GFORM_317 Article 11

Has the organization established procedures for


document and data safety?
4.24 Back up schedule
Procedure
Storage of back up
Requirement: ISO 9001 - 2015 7.5.3
ISO 9001 - 2008 4.2.3

Are emegency equipment as fire extinguisher,


4.25 emergency light, emergency exit signs etc available
Check during walk around.
Mandatory and in a condition that prevent personal hazard ? Precent at site
Precent, Functional, service agreements
Requirement: National law, approval of premisis

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 14 of 51
Eltek Supplier Asessment

5.0 Product Planning (NPI, DPR etc) Audit Worksheet Action Plan

5.1 Product Realization

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

l Quality plan and Design Record, Control


Plan, Operator Instructions, Product
l Timelines
Approval records, resources/facilities and
Is a well documented NPI process in place and l Customer
any plans to enhance them.
followed? standards/specifications
l Design validation at various stages of
5.11 Are the staff involved properly defined? l Customer change
design.
Are documentation requirements properly defined in a notifications
l Link between process changes and
development project? l Floor plan
updates in the quality plan(s).
l Planning documents
l Gantt charts, Action plans, Meeting
minutes.

l Engineering change request.


l Change in FMEAs.
l Change records.
l Change management
Is a procedure in place for production process l Test specification.
5.12 process
feedback during NPI? l Evidence of design and production
l Impact studies
validation tests conducted for product
changes.
l Design and production test report.

Is there a process to identify and/or comply with End of


Life requirements? l Material data sheets
5.13 l Policy Statement
l Banned substances list
Requirement: GPRO 10, GFORM_316 4.7

Can the organization communicate (language and


electronically) in Elteks directed formats/languages l Language of documents submitted.
lEnglish speaking
5.14 (English)? l CAD format.
personnel
l Electronic data transfer protocol.
Requirement: Observation only

5.2 Design and Development Planning, Verification and Validation Audit Worksheet Action Plan
( only where GPRO_39 and/or GFORM_252 are required)

Does the organization have a prototype process that


includes:
l Prototype facilities.
a) a prototype program and control plan?
l Prototype records.
b) use of the same suppliers, tooling and
l Prototype Procedure or l Prototype control plan.
5.24 manufacturing process that will be used in production?
Process l Prototype tooling.
c) monitoring all performance testing activities for
l Prototype test records.
timely completion and conformance to requirements?
l Subcontractor management.
d) maintenance of responsibility for subcontracted
services, including technical leadership?

Does the organization have detailed capacity planning l Standard production


5.25 l Documentation
documents? hour scheduling

Is first time quality used to determine capacity?


lShop floor plans vs.
5.26 (FTQ = Calculation of the percentage of good parts at l Documentation
Actual
the beginning of a production run)

Are elements of TAKT used to establish and improve l Formulas


capacity? l Pace Studies
5.27 l Documentation
(Available time for production / required units of l Run at Rate
production) l Projections

Does the organization have plans established to


lComparison of customer planning vs.
5.28 address sudden increases in volume or to replace l Procedure or Policy
releases to shipped material.
rejected material?

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 15 of 51
Eltek Supplier Asessment

5.3 Advanced Product Quality Planning Audit Worksheet Action Plan


( Except Mandatory, only where GPRO_39 and/or GFORM_252 are required)

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Does the organization use a multidisciplinary approach


to prepare for product realization, including:
a) development/finalization and monitoring of special l Functions represented in product
characteristics? l Product Development
development teams.
b) development and review of FMEAs including actions Teams
5.31 l Personnel involved in definition of special
to reduce potential risks? l APQP Development
characteristics, FMEA, and Control Plan.
c) development and review of Control Plans? Teams
l Prior SLP Creation and Execution

Does the organization identify special characteristics


and:
a) include all on the Control Plan? l Procedure of process map for drawing
b) comply with customer specifications and symbols? review.
c) identify process control documents including l Process to identify l Review of customer requirements for
drawings, FMEAs, control plans and operator special characteristics. special characteristics, definitions and
5.32 instructions with the customer's special characteristic l Design records. symbol identification.
symbol or an equivalent symbol/notation? l Drawing review. l Process FMEA.
l APQP documents. l Control Plan.
l Product drawings.
l Operator instructions.

Does the Process Flow Diagram show the start of the


process at the receiving dock and the stop point the
shipping dock? lDocumentation vs. l Receiving Dock
5.33
Floor l Shipping Dock

Is the Process FMEA


a) created and are improvement measures
established?
b) updated when amendments are made during launch
and the established measures implemented? l Improvements based on high RPN
c) cover items of past concerns? numbers.
d) developed to include all the steps in the Process l New items or changes in RPN numbers.
5.34 l PFMEA
Flow Diagram? l Correlation between Process Flow
e) used to drive the Continuous Improvement Process? Diagram and Process FMEA.
l Update due to customer complaint.

Does the organization

a) Develop a process Control Plan for the products


produced by the organization.
Control plans for different levels.
b) Use a PFMEA used to prepare it?
Controls identified on PFMEA are on
c) Do they review and update control plans when any Control Plan.
5,35 changes occur affecting product, manufacturing l Procedure
Mandatory process, measurement, logistics, supply sources, or l Control Plan Control Plan requirements in operator
FMEA? instructions, Gage Control, Maintenance,
etc.
d) Ensure that the control plan and process flow
diagram are followed? Evidence of implementation of Control plan

Are Mistake Proofing devices well defined for purpose l PFMEA


and intent? Are Mistake Proofing devices checked l Customer complaints.
initially and regularly per an established procedure? l Control Plan l Lessons learned.
5.36 (Mistake-proofing is the use of process or design l Devices l Operator Instructions.
features to prevent errors or the negative impact of l Good/Bad Masters l Preventive maintenance.
errors. Mistake-proofing is also known as poka-yoke l Set-up Instructions.
(pronounced pokayokay) l Documentation of test or calibration.

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 16 of 51
Eltek Supplier Asessment

6.0 Supplier Management Audit Worksheet Action Plan

6.1 Supply Chain Management


Date completed
No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due date

Has the supplier ensured that conflict minerals, in


particular gold (Au), tantalum (Ta), tungsten (W) or tin
(sn), are sourced from conflict-free zones and
according to international laws and regulations?
Is there any declaration available in in
Bomcheck/Silicon expert with up-to-date Conflict
6,11 mineral Declaration of Compliance documents ? Requests to supplier Emails and/or Letters to suppliers
Mandatory Replyfrom supplier requesting infor and replies from suppliers
Ref: Section 1502 of the Dodd Frank Act of 2010
Effective Date: November 13, 2012.

Fylles ut CFSI CRMT (sjekk med herdy)

Requirement: GPRO_018, GFORM_316


Has the supplier ensured that counterfeit and
fraudulent materials are not utilized in product or
6,12 material provided to Eltek? Request to supplier Emails and/or Letters to suppliers
Mandatory Reply from supplier requesting infor and replies from suppliers
Requirement: GPRO_018, GFORM_316

Are supplier performance monitoring processes


established, executed and followed up properly?
Including:
- Key Performance Indicators - Key Performance - KPI with targets set, do they meet
- Supplier agreements Indicators target ? What do they do if not ?
6.13 - Buffer stock levels - Supplier agreements - Content of Supplier agreements
- Supplier audits - Buffer stock levels - Buffer stock levels in ERP
- Supplier - updatedSupplier audits/plans/report
Requirement: ISO 9001 - 2015 9.1.3 audits/plans/reports with closed loop
ISO 9001 - 2008 8.4

Are proper material expediting processes in place?

- Critical material lists ? Escalation path (a clear management


Escalation path pr
6,14 chain) pr supplier and distributor
supplier and distributor
Mandatory - Escalation path (a clear management chain) pr - Critical material lists
supplier and distributor delivering critical material ? Critical material lists

Requirement : Observation only


Are purchase orders and forecast to suppliers
managed to meet operational requirements? E.g. lead-
time and monitoring and tracking of confirmation.
6,15
ERP set up or other tracking lists
Mandatory Requirement : Observation only

Are rescheduling and cancellation processes with


suppliers in place and actively followed up (including
partial cancellation)? Procedure
6.16 Examples of how it has been used
ERP process
Requirement : Observation only

6,2 Incoming Inspection, Layout and Functional Testing Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Doest the organization have a process to ensure the


quality of purchased product utilizing one of the
following:
Incoming inspection.
a) receipt of and evaluation of statistical data?
Source inspection.
b) receiving inspection and /or testing such as
6,21
sampling based on performance? l Procedure
Mandatory Audits of supplier sites.
c) assessments or audits of suppliers sites,
d) part evaluation by a designated laboratory?
Independent evaluation of acceptability of
e) another method agreed with the customer?
product by a designated 3rd party.
Requirement : ISO 9001 - 2015 8.4.2
ISO 9001 - 2008 7.4.3

Are there measures in place to avoid material


contamination, handling damage and degradation
6,22 during storage? l Raw materials and components storage
l Storage procedure
Mandatory l Containers
Requirement : ISO 9001 - 2015 8.5.4
ISO 9001 - 2008 7.5.5

Are all goods, from receipt of incoming materials


through shipment stored, and identified, for efficient
6,23 use and retrieval? lReceiving Inspection
l FIFO system
Mandatory Process Controls
Requirement : ISO 9001 - 2015 8.5.2
ISO 9001 - 2008 7.5.3

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 17 of 51
Eltek Supplier Asessment
Where applicable, are all materials with a shelf life
properly identified and still useable?
6,24
l Process Controls l Expired Material on shelves
Mandatory
Requirement : ISO 9001 - 2015 8.5.2
ISO 9001 - 2008 7.5.3

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 18 of 51
Eltek Supplier Asessment
7. MANUFACTURING
7.1 Indentification and Traceability Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Does the organization identify the product by a suitable


7.11 means throughout product realization? l Check for positive recall.
Mandatory l Lot Traceability System l Suitable product identification throughout
Requirement : ISO 9001 - 2015 8.5.2 the facility.
ISO 9001 - 2008 7.5.3
Does the traceability originate with raw material and
purchased components, i.e., nuts, screws, etc.?
7.12
l Procedure l Documentation vs. Floor
Requirement: GPRO_39 where part of contract
If not, Observation

Does the lot control reflect the last value added


process? l Procedure l Lot control should reflect batch
7.13
l Process Flow Diagram breakdown at value added processes
Requirement : Observation only

Is material identification, traceability and test status


maintained and recorded at all production stages?
7.14
Does this also include process traceability?
Mandatory l Procedure l Identification at different process stages
Requirement : ISO 9001 - 2015 8.5.2
ISO 9001 - 2008 7.5.3

Are customer requirements part of the identification


procedure?
7.15 l Procedure l Documentation
Requirement: GPRO_39 where part of contract
If not, Observation

Will Eltek production lots be defined as a maximum of


one shift of production (8hrs)?
7.16 l Procedure l Documentation
Requirement : Observation only

7.2 Production Control Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Do instructions for running the process exist (operator


instructions) for all employees having responsibilities
for the operation of processes?
Are they available in the language necessary for Eltek
7,21 lAvailability of work instructions at the
personnel to read and understand? l Visual
Mandatory workstation.
Requirement: ISO 9001 - 2015 8.5.1
ISO 9001 - 2008 7.5.1
Note : language is only Observation

Do instructions
a) have the correct content?
b) list the bill of materials, production tools, and safety
equipment needed at each operation?
c) address stop/start or line down procedures?
d) identify the critical and significant characteristics at l Complete l Operator vs. Instructions.
the stations that product them? Standardized Work
7.22 l Documentation.
l Visual
Mandatory e) take into account the literacy and language of all l Floor data.
l Control Plan
operators? l Can operators read and understand
l Speak to Operator
f) identify who is authorized to do what? instructions.
l Identification

Requirement : ISO 9001 - 2015 8.5.1


ISO 9001 - 2008 7.5.1 , 7.5.2

Are visual aids and/or boundary samples required? If


so, are they available to the operator?
7,23
l Visual equipment/aids/boundry samples
Mandatory
Requirement : ISO 9001 - 2015 8.5.1
ISO 9001 - 2008 7.5.1 , 7.5.2

7.3 Manufacturing Monitoring & Measurement Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Are quality requirements effectively monitored during l PFMEA


7,31 l Effectiveness of controls of avoid quality
serial production with the implemented inspection, l Control Plan
Mandatory issues
measuring and test equipment? l Quality History

7,32 Are defined and separate containers available for l Control Plan l Containers
Mandatory good, rework, and scrap product? l Visual l Disposition documents

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 19 of 51
Eltek Supplier Asessment
l Customer or product based production
Are concepts of lean production, cellular
units.
7.33 manufacturing, JIT implemented throughout the l Floor Plan
l Material management system.
facility?
l Allot storage for incoming materials.

l Dry mark boards


Are production goals monitored by the operator(s) lProduction vs. Scrap l Requirements vs. Actual Production
7.34
using visual management tools? Data Report
l Downtime Records

Are the operators given responsibility and authority of


l Job Descriptions
7.35 the production equipment and environment? l Operators job responsibilities
l Procedure
Are operators authorized to shut down the line?

7,36 Are Inspection Instructions available for operators at lPosted or readily referenced inspection
l Inspection Instructions
Mandatory each production station? Are they being followed? requirements

Does each item on the control plan have inspection


7,37 lProduction Control
instructions associated with it? l Control Plan vs. Instructions vs. Floor
Mandatory Plan vs. Instructions
Does this include final audit?
7,38 Does the procedure for non-conforming material lInternal rejections vs. Customer
l Containment Plan
Mandatory prevent it from reaching the customer? rejections
l Logs
If there is more than one shift, how does information
7.39 l Procedure l Interviews
get passed across shifts?
l Pre-shift/Handover Meetings

For appearance items, does the supplier have the l Equipment required to
7,310 l Light booths
appropriate resources in place, i.e., lighting for qualify appearance
Mandatory l Color Analysis Machines, etc.
evaluation? items

For appearance items, does the supplier have masters Masters Proper storage area with masters
7,311 for color, grain, gloss, texture, etc., as appropriate? Color Testing Authorized personnel must be capable to
Mandatory For appearance items, are authorized personnel Training Records review appearance items and have proper
properly qualified and trained? Vision Testing training

Does the organization release product only after all the


7.312
requirements have been satisfactorily completed, lMaterial is released only if all
Mandatory l Control Plan
unless otherwise approved by a relevant authority, and requirements are met.
where applicable by the customer?

7.4 Inventory and Storage Audit Worksheet Action Plan

Date Completed
No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date

Does packaging and material handling protect parts


from damage and contamination:
7.41 a) during internal processing?
b) during delivery to the intended destination? l Packaging reviews.
Mandatory l Procedure
l Proper utilization.
l PFMEA
Requirement : ISO 9001 - 2015 8.5.4 l Plant tour.
ISO 9001 - 2008 7.5.5

Is the raw material/finished goods stored in specific


locations? Is storage appropriate to prevent damage
and deterioration?
7,42 lDocumentation vs.
l Plant Layout
Mandatory Floor
Requirement : ISO 9001 - 2015 8.5.4
ISO 9001 - 2008 7.5.5

l Compare dates to assure oldest material


7.43 Is First In/First Out maintained at each operation? l Part Container dates is processed first
l WIP Dates

Are customer requirements for shipping methods, l Assembly plant


7.44 l Assigned carriers
routings, and carriers observed? l Shipping Instructions

l Shipping Records
Are system and procedures in place to ensure effective l Past Due
7.45 * On time Delivery
delivery performance? Are corrective actions taken? l Premium Freight
measurement ( KPI)

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 20 of 51
Eltek Supplier Asessment
7.5 Preventive Maintenance Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Does the organization determine, provide and maintain


the infrastructure needed to achieve conformity to l Buildings, workspace and associated
product requirements? facilities.
7,51 l Process equipment, both hardware and
l Plant Tour
Mandatory Requirement : ISO 9001 - 2015 7.1.3 software.
l Supporting services, e.g., transportation,
ISO 9001 - 2008 6.3
communication, etc.

Is the organization's plant layouts optimized for


material travel, handling and value-added use of floor
space and shall facilitate synchronous material flow? l Process flow analysis.
l Plant layout (current and planned).
7.52 l Plant Tour
Requirement: SO 9001 - 2015 7.1.3 l Delivery point/Shipping point.
ISO 9001 - 2008 6.3, l Material staging areas.

Has the organization prepared contingency plans to


satisfy the customer requirements in the event of an
emergency such as utility interruptions, labor
shortages, key equipment failure, and field returns? l Key equipment identified.
7.53 l Contingency plans l Material and component supplier profiles.
Requirement : GPRO_018 l Identification of critical suppliers/services.

l Facility Tour, including office areas.


Does the organization maintain its premises in a state
l Cleanliness.
of order, cleanliness and repair consistent with the
l Lighting.
7,54 product?
l Policy Statement l Housekeeping instructions.
Mandatory
l Floor markings and signs.
Requirement : ISO 9001 - 2015 7.1.3 & 7.1.4
l Material flow from one end to the other.
ISO 9001 - 2088 &.3 & 6.4
l Visual management tools.

Does the preventive maintenance system minimally


include:
a) planned maintenance activities?
b) packaging and preservation of equipment, tooling,
gauging?
c) availability of replacement parts for key l Key equipment list.
7.55 manufacturing equipment? lPreventive l Maintenance records.
Mandatory d) documenting, evaluating and improving Maintenance process l Predictive maintenance examples.
maintenance objectives? l Plant tour.

Requirement: ISO 9001 - 2015 7.1.3


ISO 9001 - 2008 6.3

Does the facility have defined Product Maintenance


responsibilities (maintenance, operator, etc)? l Operator instructions.
7,56
l Documentation l Set-up/shut down procedures.
Mandatory
Requirement : Observation only l PM procedure.

Does the organization have resources available for tool


and gauge design, fabrication and verification
7,57 activities? l Procedure lTool/gage design staffing and
Mandatory l Organization Charts qualification.
Requirement : Observation only

Does the facility have resources available for the


maintenance and repair of tooling/gauging? l Tool room staffed with appropriate
7,58 lTool Management
personnel.
Mandatory Requirement : Observation only process
* 3'rd part

Is there a system to manage revisions to tools based


on customer engineering changes?
Is there evidence that the supplier properly notifies l Records.
7,59 their customers when tooling undergoes l Procedure l Customer Notification communications.
Mandatory refurbishment? l PPAP.
Is the tool properly requalified?

In regard to customer property, does the organization:


a) exercise care while under its control?
b) identify, verify, protect and safeguard the property
provided for use or incorporation into the product?
c) report and maintain records for property that is lost,
damaged or otherwise found unsuitable for use? l Identification.
7,60
l Procedure l Storage environment.
Mandatory Requirement: ISO 9001 - 2015 8.5.3 l Damage reports.
ISO 9001 - 2008 7.5.4

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 21 of 51
Eltek Supplier Asessment

8.0 Quality Control Audit Worksheet Action Plan

8.1 Quality Control


No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Are records of final inspection and test


maintained?
Is there a record of first article inspection for
new test fixture?
8,11 Do inspection records show that product has Test/inspection reports
passed or failed? Test/inspection reports
Mandatory FAI report
Requirement: ISO 9001 - 2015 8.6
ISO 9001 - 2008 8.2.4

Can inspection and test status of products be


readily identified?
Traceability procedure
8,12 Is complete part/lot traceability maintained? ID tags
Traveller
Mandatory
ID tags with status
Requirement: ISO 9001 - 2015 8.6
ISO 9001 - 2008 8.2.4

Are there documented procedures for non-


conforming product found during production?
Procedure
*Is non-conforming product identified and
Process flow
segregated? "red" bins
Segregation of non-conforming material
*Are reworked, repaired or modified product re- Non-conforming material
8,13 into bins etc and/or Locked areas
inspected or re-tested? tag
Mandatory CA review of effectiveness ( is it
*Are corrective action reviewed to ensure they are Inspection label
reasonable time between implementation
effective?
and verification of effectiveness of the
action ?)
Requirement. ISO 9001 - 2015 8.7
ISO 9001 - 2008 8.3

Is ther an effective process for handling customer


complaints?
Procedure
Is information on actions taken submitted for 8D reports / Customer
8,14 Process description
management review? complaint forms with
Mandatory Register of customer complaints
closed loop
KPI's
Requirement : ISO 9001 - 2015 8.2.1, 8.6, 8.7
ISO 9001 -2008 7.2.3, 8.2.4, 8.3

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 22 of 51
Eltek Supplier Asessment
8.2 Statistical Process Control Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Does the organization determine the appropriate


statistical tools for each process and include them in
l Review of control plan.
8,21 the control plan? l Procedure
l Review of quality plan.
Mandatory l Control Plan
l Plant floor.
Requirement: GPRO_39 & 252 where part of contract
In other cases - Observation

Are short-term capability studies conducted on new or


changed processes and equipment accoring to
requirement in PQP ? lCapability studies for parts recently
8.22 l Procedure
validated and new production equipment.
Requirement: GPRO_39 & 252 where part of contract
In other cases - Observation

Does the supplier calculate long term capability?


8,23
l Procedure l Capability studies for parts in production.
Mandatory Requirement: GPRO_39 & 252 where part of contract
In other cases - Observation

Does the supplier have a statistically based l Blackbelts.


l Documentation
8.24 Continuous Improvement Process (CIP), e.g., Six l CIP reports.
l Organization Charts
Sigma? l Posted charts/graphs.

Does the organization's reaction plans for unstable or l Contents of reaction plan for unstable
8,25 l Control Plans
non-capable characteristics include containment and and noncapable processes.
Mandatory l Reaction Plans
100% inspection as appropriate? l Records.

Does the organization establish a corrective action


lCorrective Action
8.26 following the initiation of reaction plans, indicating l Corrective actions for initiated reactions.
Reports
specific timing and assigned responsibilities?

Are the organization's corrective action plans reviewed l Corrective Action


8.27 l Corrective action reports.
with and approved by the customer when so required? approval process

Does the organization maintain records of the effective


dates of process changes?
l Records of process change dates.
8,28 lProcess change
l Instructions for proper product
Mandatory Requirement : ISO 9001 - 2015 8.5.1 management process
identification
ISO 9001 - 2008 7.5.2
GPRO_306 where applicable

8.3 Control of Monitoring & Measurement Devices Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed
Are all inspection and test equipment affecting product l Test equipment inventory.
quality: l Certifications for calibration masters and
a) identified enabling calibration status to be their traceability to international national
determined? recognized standard.
b) calibrated at prescribed intervals, or prior to use, l Calibration results records.
against measurement standards traceable to l Method of control of calibration settings.
international or national measurement standards? l Procedures
l Calibration status identification.

8.31 c) adjusted or readjusted as necessary? l Documentation


l Type, Identifier, Location, Calibration

Mandatory d) safeguarded from adjustments that would invalidate l Calibration Instructions frequency, method, Gage R&R status,
the measurement result? for each type of Acceptance criteria, results, actions
e) protected from damage and deterioration during equipment l Gage/Test Equipment Control System
handling, maintenance, and storage?

Requirement : ISO 9001 7.1.5.1 & 7.1.5.2


ISO 9001 - 2008 7.6

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 23 of 51
Eltek Supplier Asessment

8.4 Non-Conforming Product Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Is there a formal system to determine the disposition of


rejected material?
8.41
Does this incude rework processes?
Mandatory l Procedure l Material Review Board with dispositions.
Requirement: ISO 9001 - 2015 8.7
ISO 9001 - 2008 8.3

Does the organization ensure that product which does


not conform to requirements is identified and controlled
l Follow one or more nonconforming case
8.42 to prevent its unintended use or delivery?
and verify the flow (identification,
Mandatory l Procedure
segregation, etc.).
l Obsolete parts.
Requirement: ISO 9001 - 2015 8.7
ISO 9001 - 2008 8.3

Do repair/rework materials return through the normal


production controls?
l Flow or repair/rework in the production
Does supplier obtain customer approval for rework l Procedure stating point
8.43 system.
process? of return to production
l Closed loop re-entry into production
flow
system
Requirement: ISO 9001 - 2015 8.7
ISO 9001 - 2008 8.3

Does the organization:


l Examples.
a) maintain a record of the expiration date or quantity
l Record of authorization with expiration
authorized by the customer concession or deviation?
date.
8,44 b) ensure compliance with the original or superceding
l Procedure l Inspection results for material shipped
Mandatory specifications and requirements when the customer
under concession.
concession or deviation expires?
l Proper label/identification for material
c) properly identify on each shipping container material
shipped on authorization.
shipped on the concession authorization?

Is there a process in place to notify customers of


suspect material either at the customer location or in
8,45 route?
l Procedure l Examples.
Mandatory
Requirement: ISO 9001 - 2015 8.2.1
ISO 9001 - 2008 7.2.3

Does the organization have a system established to


evaluate returned parts from their customer's and do
they know requirements of the controlled shipping l Records of analysis.
process ? l List of returned parts.
8,46
l Procedure l Minimalization of cycle time.
Mandatory
Requirements : ISO 9001 - 2015 8.5.5 l Review product/test analysis.
ISO 9001 - 2008 7.5.1 l Records.
(if agreed in contract, if not -
Observation)

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 24 of 51
Eltek Supplier Asessment

8.5 Improvement Processes Audit Worksheet Action Plan

Date Completed
No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date

Does the supplier have a Continuous Improvement


Process they apply to their processes and products?
l Six Sigma program.
Does the organization use the PFMEA as part of this l Procedure
l Continuous Improvement Process
process? l Organization Chart
8.51 reports.
Is there a focus on reduction of product and process l Reduction in process
l Posted charts/graphs.
variation? variation
l PFMEA
l RPN Improvement
l Quality Improvement Plans
Requirement: ISO 9001 - 2015 10.3
ISO 9001 - 2008 8.5.1

Is there a documented plan to address nonconforming


8.52 material in order to prevent recurrence?
Mandatory l Procedure l Procedure vs. Practice
Requirement: ISO 9001 - 2015 10.0
ISO 9001 - 2008 8.5.2

Does the organization have a system to determine the


severity of the problem in terms of cost penalties both
internally and to the customer? Are these cost l Procedure.
l Cost of Quality System.
8.53 penalties measured and tracked as part of the l Management
l Monthly Financial reports of cost vs. plan
supplier's monthly operating plan? Documentation

Requirement: Observation only

Is 100% Sort implemented as a containment action


until permanent corrective action is implemented and
8,54 l Sort records.
verified? l Sorting area
Mandatory l Paynter Charts.
Requirement: Observation only

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 25 of 51
Eltek Supplier Assessment
Supplier Facility Audit

Supplier Name: Full Compliance / Performing well


December 30, 1899 Compliance / Performing Acceptable
Partial Compliance/Marginal Acceptance
Audit Date: with Action Plan
30-Dec-1899
No Compliance/Major Issues

20.01 Die Cast Module Audit Worksheet ACTION PLAN

No. Process Look For Status Observations Actions Responsibility Date Due Date Completed

Die Verification/Machine l Traveler designates correct tool number.


Preparation l Tool is verified ready for use.
l Machine maintenance records.
l Tool set-up instructions.
l Die(s)/Machine(s) have protection sensors.

20.011 l Set-up instructions include adequate lubrication/die spray.


l Temperature, Pressure and Key Injection parameters
alarms in place and operational.

Material Preparation l Material listed on traveler.


l Metal temperature is established and documented.
l Hydrogen concentration in melt is within tolerance.
l Oxide and/or sludge concentrations are checked for.

20.012 l Plunger condition and shot fill are checked.


l Die temperature is monitored.
l Auto ladle fill (shot size) is checked at designated
intervals.

Production l Set-up instructions define process parameters.


l Die set-up is verified.
l Check shot parameters to specification limits.
l Operator inspection.
l First part inspection and approval.
l First piece sample.
20.013 l Calendar is correctly set, if applicable.
l Instructions direct clean up of set-up parts.
l Routines for dross removal are effective.
l Instructions reflect relevant customer requirements

Part Cooling and Trim l Instructions should include:


m Part temperature at end of conveyor.
m Conveyor speed.
m Part location at trim press.
m Condition of knives, locations, stripper.
20.014
m Check for debris in locating nest.
m Check for limit switch operation.
l Instructions reflect relevant customer requirements

Machining Operations l Instructions should include


m Check for worn or damaged bits.
m Check for correct tool sizes.
m Check for proper feature location.
m Check for missing features (holes, etc.).
20.015
m Check burrs and false cuts.
m Check for material damage (cracks, etc.).
l Instructions reflect relevant customer requirements

Deburr, Rinse, and Drying l Instructions should include:


m Media (size and type).
m Check for parts left in vibe bowl.
m Check for parts damaged in tumbler.
m Check for media stuck in parts.

20.016 m Soap concentration.


m Check for rate of water.
m Check for parts left in dryer after shut down.
m Check parts for cleanliness.
l Instructions reflect relevant customer requirements

Date: 2016-03-02 479476151.xlsx; Die Cast Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No:GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 26 of 51
Supplier Facility Audit

Supplier Name: Full Compliance/Performing Well


### Compliance / Performing Acceptable
Partial Compliance/Marginal Acceptance
Audit Date: with Action Plan
30-Dec-1899
No Compliance/Major Issues

20.02 Plastics Audit Worksheet ACTION PLAN


Date
No. Process Look For Status Observations Actions Responsibility Date Due
Completed
Mold l Traveler designates correct tool number.
Verification / l Tool is verified ready for use.
Machine l Machine maintenance records.
Preparation l Tool set-up instructions.
l Die(s) / Machine(s) have protection sensors.
l Set-up instructions includes adequate lubrication/die
20.021 spray.
l Barrel and screw cleaned after material change.
l Temperature, Pressure and Key Injection parameters
alarms in place and operational.

Material l Material listed on traveler.


Preparation l Check regrind % allowance against actual.
l Instructions include hopper cleaning and preparation.
20.022 l Pre-dry can keep pace with production.
l Verify clean shots.

Production l Set-up instructions define process parameters.


l Mold set-up is verified.
l Check shot parameters to specification limits.
l Operator Inspections.
l First part inspection and approval.
l First piece sample.
20.023
l Moisture testing.
l Calendar is correctly set for day, time, shift, if applicable.
l Instructions reflect relevant customer requirements

Insert Molding l Traveler designates correct inserts.


l Inserts are inspected per Control Plan.
l Instructions show insert orientation.
20.024
l Insert has protection sensor.
l Visual inspections conducted per Control Plan.

Secondary l Set-up instructions are complete and appropriate for each


Operations operation.
l Correct tools and their usable conditions are documented.
20.025 l Automatic inspections are verified against standards.
l Inspections are conducted per Control Plan.

Date: 2016-03-02 479476151.xlsx; Plastics Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 27 of 51
Supplier Facility Audit

Supplier Name: Full Compliance/Performing Well


### Compliance / Performing Acceptable
Partial Compliance/Marginal Acceptance
Audit Date: with Action Plan
30-Dec-1899
No Compliance/Major Issues

20.02 Plastics Audit Worksheet ACTION PLAN


Date
No. Process Look For Status Observations Actions Responsibility Date Due
Completed
Part Painting l Instructions should include
m Approved paint type, number and source are used.
m Paint is correctly mixed; viscosity is correct.
m Paint lines are flushed and cleaned between colors.
m Any masking is properly applied.
m Parts are properly racked.
m Line speed and oven temperatures.
20.026 m Paint quality checking
(color//gloss/thickness/adhesion/wear resistance..)
m Checking for contamination, sags, runs, orange peel.
l Instructions reflect relevant customer requirements

Pad Print l Instructions should include


m Correct cliches and fixtures are used.
m Correct ink type and color.
m Proper pad material, pad shape, registration and
coverage verification.
20.027 m Graphics clarity definition and inspection.
m Line speed and oven temperatures.
m Color, gloss, fluid and wear resistance checking.
l Instructions reflect relevant customer requirements

Laser Etch l Instructions should include:


m Part fixtures.
m Laser set-up and settings.
m Graphics program and its tolerance limits.
20.028 l Program runs within preset limits are verified.
l Color and clarity of graphics are verified.
l Parts are inspected per Control Plan.

Date: 2016-03-02 479476151.xlsx; Plastics Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 28 of 51
Supplier Facility Audit

Supplier Name:
Full Compliance / Performing well

Compliance / Performing Acceptable


December 30, 1899
Partial Compliance/Marginally Acceptable
Audit Date: with Action Plan
30-Dec-1899
No Compliance / Major issue

Sheet metal Audit Worksheet ACTION PLAN


Date
No. Process Look For Status Observations Actions Responsibility Date Due
Completed
l Traveler designates correct tool number.
l Tool is verified ready for use.
l Machine maintenance records.
Tool Verification/Machine
20.041 l Tool set-up instructions.
Preparation

l Material designated on traveler.


l

20.042 Material Preparation

l First part inspection and approval.


l Parts are inspected per Control Plan.

20.043 Production

lInstructions should include:


m Proper cleaning process.
m Proper equipment settings.
m Standard/instructions for cleaning effectiveness.
In-House Parts Cleaning / m Standard/instructions for deburring effectiveness.
20.044
Deburring l Inspection per Control Plan.

20.045

l Proper outside processes are shown on traveler.


l When there is a customer approved supplier list, for
outside processing, the supplier sources to that list.
l Proper controls are in place, upon the return of parts, to
20.046 Outside Processing assure the parts meet specification requirements.

Date: 2016-03-02 479476151.xlsx; Sheet metal Process Owner/Department:


Revision: 7 R. Langtangen/Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 29 of 51
Supplier Facility Audit

Supplier Name: Full Compliance/Performing Well


### Compliance / Performing Acceptable
Partial Compliance/Marginal Acceptance
Audit Date: with Action Plan
30-Dec-1899
No Compliance/Major Issues

20.03 Magnetics Audit Worksheet ACTION PLAN


Date
No. Process Look For Status Observations Actions Responsibility Date Due
Completed
Tool l Traveler designates correct tool number.
Verification l Machine maintenance records.
20.031 and l Tool set-up instructions.
Machine
Preparation
Material l Material listed on traveler.
20.032 Preparation l Roller pressure is shown and correctly set.

Production l Set-up instructions define machine settings.


Run (Coiler) l Tool set-up is verified.
l Assure process parameters are established.
20.033 l Operator Inspections define first part approval activity.
l Machine is cleaned between set-up and production.
l Process inspections are defined in Control Plan.

Stress Relief l Instructions define:


m Heat Treatment requirements.
m Time and Temperature settings.
20.034
m Proper part loading and handling.
m Proper unloading and handling.

Outside l Proper outside processes are shown on traveler.


Processing l When there is a customer approved supplier list, for
outside processing, the supplier sources to that list.
l Proper controls are in place, upon the return of parts, to
20.035 assure the parts meet specification requirements.
l Test laboratories, including the supplier, meet
ISO/IEC17025 requirements.

Date: 2016-03-02 479476151.xlsx; Magnetics Process Owner/Department:


Revision: 7 R. Langtangen/Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 30 of 51
Supplier Facility Audit

Supplier Name: Full Compliance/Performing Well


### Compliance / Performing Acceptable
Partial Compliance/Marginal Acceptance
Audit Date: with Action Plan
30-Dec-1899
No Compliance/Major Issues

20.05 PCB Audit Worksheet ACTION PLAN


Date
No. Process Look For Status Observations Actions Responsibility Date Due
Completed
1>. Is there good routing for warehouse.
2>. Is there any system to control FIFO.
3>. Is there system for material traceability.
Raw material 4>. Is there any dedicated area for MRB material.
20.051
warehouse 5>. Enriroment well controlled.
6>. Raw material life time well controlled.

1>. The procedure and work instruction are available.


2>. The sample plan well defined.
Incoming 3>. The capability for raw material inspection.
20.052 4>. If any special inspection process for waive expired material.
inspection.
5>. The capability for chemical raw material inspection.

1>. Pre-treatment is well set.


2>. The clean room dust level well controlled.
Film & Etching 3>. The film exposure parameter well set
process (for 4>. The AOI requirement well defined in process.
20.053 4>. The post-treatmenet is well set.
inner and outer
layer) 5>. The brown oxidation rework time well defined.
6>. The etching parameter well set.

1>. The environment control for lay-out room well controlled.


2>. Well control the dust level for prepreg lay-out room.
Pressing 3>. The press parameter well controlled or not.
20.054
process 4>. If any vacuum function for press machine.
5>. Any deburr process after pressing.

1>. Good routine for drill bit re-sharp.


2>. The drill bit life time well setting.
Drilling/routing 3>. The enviroment temperature & humididty well controlled.
20.055
process 4>. No recycle used routing bit.
5>. The drill depth well controlled.
1>. The backlight stardard is well defined.
2>. The plating equipments are well maintained.
20.056 Plating process 3>. The vibration function is regularly checked.
4>. The chemical solvent analysis are well defined and implemented.
5>. The plating parameter for each board are well documented.

1>. The pre-treatment parameter well set.


2>. The baking parameter are well defined and implemented.
3>. The exposure parameters are well set.
Solder mask 4>. The solder mask print time for different copper thickness are well defined
20.057
process and implemented.
5>. The solder mask life time are well controlled.

1>. The HASL pre-treatment paramnter well set.


2>. The HASL pr-treatment parameter well set.
3>. To check if copper extration equipment available.
Surface 4>. The HASL equipment well maintained.
20.058
treatment 5>. The solder thickness well defined and sampled.
6>. To check if any other surface treatment process available.

1>. The bake requirement defined before packing.


Packing 2>. If any vacumn machine for thick platic bag.
20.059
process 3>. The exposure time between baking and packing well defined.

Date: 2016-03-02 479476151.xlsx; PCB Process Owner/Department:


Revision: 7 R. Langtangen/Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 31 of 51
Supplier Facility Audit

Supplier Name: Full Compliance/Performing Well


### Compliance / Performing Acceptable
Partial Compliance/Marginal Acceptance
Audit Date: with Action Plan
30-Dec-1899
No Compliance/Major Issues

20.05 PCB Audit Worksheet ACTION PLAN


Date
No. Process Look For Status Observations Actions Responsibility Date Due
Completed
1>. To Check if golden sample to verify test fixture for each board.
2>. The open/short specification well defined.
20.060 E-test 3>. The test pass board well marked.
4>. The pass/fail board status well marked.

Date: 2016-03-02 479476151.xlsx; PCB Process Owner/Department:


Revision: 7 R. Langtangen/Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 32 of 51
Supplier Facility Audit

Supplier Name: Full Compliance/Performing Well


Compliance / Performing Acceptable
Partial Compliance/Marginal Acceptance
Audit Date: with Action Plan

No Compliance/Major Issues

PCBA Audit Worksheet ACTION PLAN


Date
No. Process Look For Status Observations Actions Responsibility Date Due
Completed
Stencil cleaning
* Suitable process/method for cleaning the stencil.
* Suitable way to check the stencil tension after cleaning.
* Suitable way to inspection the stencil cleaning result.
* Suitable way to statistic the stencil life time.Stencil check
and stencil cleaning

Solder paste handling


* The solder paste stored properly.
* The solder paste proper handling before use.

Solder paste printing


* The solder paste printed automatically, semi-automaticlly
or manually.
* Solder paste thickness proper checked.
* Solder paste residue cleaning frequency from bottom side
of stencil proper defined.

Traceability
* Reel of component well traced.
* Template of SMT support pin are well traced.

SMT pick & place


Preparation & Production * All the SMT component picked & placed by equipment.
20.071
SMT area * Pick and place equipment well calibrated and
maintananced.
* The pick & place parameter well defined and controlled.
* FAI properly defined and controlled.

Reflow oven profile


* The reflow profile proper defined and controlled.
* The reflow profile proper measured everyday.

Inspection
* The inspection method after SMT well defined (by AOI or
template etc) and controlled.
* The AOI machine has the right program for the specific
product.

Panel cutting
* Check method and equipment for panel cutting (V-cut).
* V-cutting machine well maintananced.
* If any other panel cutting method used in company that
can create the strain force.
20.072 Preparation THD area

Date: 2016-03-02 479476151.xlsx; PCBA Process Owner / Department:


Revision: 7 R. Langtangen/Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 33 of 51
Supplier Facility Audit

Supplier Name: Full Compliance/Performing Well


Compliance / Performing Acceptable
Partial Compliance/Marginal Acceptance
Audit Date: with Action Plan

No Compliance/Major Issues

PCBA Audit Worksheet ACTION PLAN


Date
No. Process Look For Status Observations Actions Responsibility Date Due
Completed
Manual Component Insertion
* The PCBA proper baked or not before manual component
insertion.
20.073 Production THD area * WI available / Comp placement drawing available
* ID on component boxes
* Using Gloves or finger cots
* FAI well implemented.
Cooling fins, transistors, SIL pads
* Cleanliness
* Equipment
20.074 Production THD area
* Process ( manual ? Semi automatic ? )

Suitable carriers
* Handling method
20.075 Production THD area * Stacking & protection

Production THD area Cutting component legs on THT components


* Equipment
* Protection ( both operator and production line)
* Process/method
20.076 * The component properly pre-cut.
* Proper fixture & tool used for component pin pre-form.

Production THD area Solder machine maintenance & Cleaning


* Maintenance schedule
* Maintenance log
* Cleaning schedule
20.077 * Cleaning log
* Process set up, conveyer speed, fluxer unit, pre-heat
zones, heating solder pot, cooling time etc.

Date: 2016-03-02 479476151.xlsx; PCBA Process Owner / Department:


Revision: 7 R. Langtangen/Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 34 of 51
Supplier Facility Audit

Supplier Name: Full Compliance/Performing Well


December 30, 1899 Compliance / Performing Acceptable
Partial Compliance/Marginal Acceptance
Audit Date: with Action Plan
30-Dec-1899
No Compliance/Major Issues

20.08 Assembly Audit Worksheet ACTION PLAN


Date
No. Process Look For Status Observations Actions Responsibility Date Due
Completed
Are current procedures and work instructions available for each
assembly process?
- are they in common language
- are they clear enough for the operators
20.081 Assembly - are they up do date and revision controlled (avoid obsolescence)

Is the material handled, stored properly without possible damage


(ESD, gloves, boxes, environment)
20.082 Assembly

Is there a traveller (process identification card) available?


- is it up to date and filled out properly?
- is there evidence of performed in -process inspection
20.083 Assembly - are the opertions clear and traceability kept (link to operators,
batch, tooling)?

Is the proper tooling available (quality, amount)?


- not damaged (jigs, fixtures)
20.084 Assembly - calibrated
- evidence of the defined maintenacne

Is there a process for the First piece assembly, inspection of the


first piece and release to a serial production?
- checklist from the FP inspection
20.085 Assembly - notes and take over process to serial production defined

Is there a system for the change over process, change notification


in place?
- how is the WIP update controlled
20.086 Assembly

What is the process for the workmanship/ final inspection?


- is product held until inspection is done
- is the ERP notification in place (stop order, ANDON)
- is there a control of the repaired product (new inspection)
- is there a record of the repair details linked to the SN, batch in
20.087 Assembly ERP
- are records of the inspection kept?

Are critical processes defined?


- are critical processes controlled
- are deviations measured and actions taken?
20.088 Assembly
- are the records kept?

*
Date: 2016-03-02 479476151.xlsx; Assembly Process Owner / Department:
Revision: 7 R. Langtangen/Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 35 of 51
22.0 Lithium Ion batteries

No. Question Look For

Are battery cells and pcba produced by a sub-


supplier?
If by a Sub-supplier -
Are supplier performance monitoring processes
established, executed and followed up properly?
Including:
22.001 - Key Performance Indicators
- Supplier agreements
- Buffer stock levels
- Supplier audits

Requirement: ISO 9001 - 2015 9.1.3


ISO 9001 - 2008 8.4

Are PCBA designed and component sourced by a


sub-supplier?
If by a sub-supplier -
A) Any involvement for PCBA design verification from
battery supplier. ?
B) Any PCBA NPI involvement from battery supplier.?
C) Any PCBA component AVL selection involvement
from battery supplier ?
22.002
D) Are PCBA components sourced by sub-supplier or
battery supplier.?
E) Is expired material controlled by sub-supplier or
battery supplier.?
F) Any component from spot market verification
process.?
G) Are PCBA engineering changes well
communicated with battery supplier. ?

Is a well documented NPI process in place and


followed?
22.003 Are the staff involved properly defined?
Are documentation requirements properly defined in a
development project?

The PCBA reliability verification procedure.

A) Necessary reliability test well defined. ?


22.004
B) Necessary reliability test well implemented.?

C) PCBA life time well defined and verified?


Does the organization

A) Develop a process Control Plan for the products


produceds ?.

B) Use a PFMEA used to prepare it?


22.005
C) Do they review and update control plans when any
changes occur affecting product, manufacturing
process, measurement, logistics, supply sources,
or FMEA?

D) Ensure that the control plan and process flow


diagram are followed?

Does packaging and material handling protect parts


from damage and contamination:
22.006
A) during internal processing?
B) during delivery to the intended destination?

ESD
* Tables, chairs
* Clothing
22.007 * Arm wrist straps
* Check of arm wrist straps
* Check of tables, chairs etc
* Floor and grounding system.

22.008
Audit Worksheet

Look For Status Finding/Evidence


Audit Worksheet Action Plan

Root Cause Action ResponsibilityDue Date


Date Completed
4
3
2
1
0
NA
Supplier Facility Audit

Supplier Name: Full Compliance/Performing Well


December 30, 1899 Compliance / Performing Acceptable
Partial Compliance/Marginal Acceptance
Audit Date: with Action Plan
30-Dec-1899
No Compliance/Major Issues

20.200 Logistics Audit Worksheet ACTION PLAN


Date
No. Process Look For Status Observations Actions Responsibility Date Due
Completed
Adequate in-out bound dock area, constructed for
container, truck un-loading, loading, temporary
storage, etc.
20.210 Warehouse

Adequate segregated staging, marshalling, packing,


shipping area, separate from 20.091
20.220 Warehouse

Packing equipment such as; strapping machine, pallets,


plastic foil, rapping, etc.
20.230 Warehouse

Loading, unloading capabilities, forklifts, pallet jacks


20.240 Warehouse

Inventory control system warehouse management


system (WMS) & its capabilities
20.250 Warehouse

Real-time stock visibility, location, quantity,


description, transactions, etc.
20.260 Warehouse

Date: 2016-03-02 479476151.xlsx; Logistics Process Owner/Department:


Revision: 7 R. Langtangen/Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 44 of 51
Supplier Facility Audit

Supplier Name: Full Compliance/Performing Well


December 30, 1899 Compliance / Performing Acceptable
Partial Compliance/Marginal Acceptance
Audit Date: with Action Plan
30-Dec-1899
No Compliance/Major Issues

20.100 Forwarder Audit Worksheet ACTION PLAN


Date
No. Process Look For Status Observations Actions Responsibility Date Due
Completed
Does every car have the Technical ID (which
guarantees minimum technical/environmental
requirements)
-up to 3,5t vehicles regular technical check every 2
years after 4 years if new – (or national law)
20.110 Vehicles -over 3,5t vehicles regular technical check every 1 year
- (or national law)
Company’s fleet meets at least EURO5 (some EURO6)
standards

Company has in place a CO2 emissions reporting


system
20.120 Environment

Company has in place and documented:


Corporate Social - Monitoring, control, and corrective actions for lawful
vehicle technical conditions (Origin, Transit,
20.130 Responsibility (CSR),
Destination Countries)
incl. Health & Safety

Company has in place and documented:


- Monitoring, control, and corrective actions for ‘lawful
Corporate Social miles driven.
20.140 Responsibility (CSR),
incl. Health & Safety

Date: 2016-03-02 479476151.xlsx; Forwarder Process Owner/Department:


Revision: 7 R. Langtangen/Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 45 of 51
Eltek Supplier Asessment
SUPPLIER TRACEABILITY AUDIT (ONLY VALID FOR CM'S & INT) FINDINGS SUMMARY
Supplier Name: Supplier Representatives: Audit Date: SEVERITY No of Findings

Address: No Compliance/major Issues related to required standards and/or


MAJOR agreements signed by Eltek & Supplier.
Full Compliance/Performing Well References to requirements needed.

City/State/Zip:
Compliance/performing acceptable Partial Compliance/Marginally acceptable with action plan. Issues related
MINOR to required standards and/or agreements signed by Eltek & Supplier.
References to requirements needed.
Country: Eltek Representatives: Partial Compliance/Marginally
Acceptable with Action Plan

Findings related to issues not covered by requirements required by Eltek or


If the finding can't be referred to in agreements/requirements. Can be used
OBSERVATION
No Compliance/Major Issues for Improvement suggestions as well.
NO references to requirements needed.

1. General Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Has supplier received Eltek Traceability Policy


21.010
document (GPRO_07 Traceability Policy)?

Has supplier received/agreed marking requirements


21.020
with Eltek for all products?

Has supplier agreed marking requirements with Eltek


21.030
on all packaging solutions?

Is traceability ownership defined (roles and


21.040
responsibilities)?

Is traceability with your own suppliers defined and


21.050
agreed?

21.060 Are traceability levels defined?

21.070 Has a traceability FMEA been performed?

Has all action points form such traceability FMEA been


21.080
closed?

21.090 Is network and connection to ETS server satisfactory?

Does everyone have access to ETS User Guides on


21.100
ELVIS?

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 46 of 51
Eltek Supplier Asessment
SUPPLIER TRACEABILITY AUDIT (ONLY VALID FOR CM'S & INT) FINDINGS SUMMARY
Supplier Name: Supplier Representatives: Audit Date: SEVERITY No of Findings

Address: No Compliance/major Issues related to required standards and/or


MAJOR agreements signed by Eltek & Supplier.
Full Compliance/Performing Well References to requirements needed.

City/State/Zip:
Compliance/performing acceptable Partial Compliance/Marginally acceptable with action plan. Issues related
MINOR to required standards and/or agreements signed by Eltek & Supplier.
References to requirements needed.
Country: Eltek Representatives: Partial Compliance/Marginally
Acceptable with Action Plan

Findings related to issues not covered by requirements required by Eltek or


If the finding can't be referred to in agreements/requirements. Can be used
OBSERVATION
No Compliance/Major Issues for Improvement suggestions as well.
NO references to requirements needed.

2. PRODUCT DATA INPUT_ETS Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

21.110 ETS: Are product data records being updated?

ETS: Are old revisions being set to LOCK to prevent


21.120
printout of serial number labels for old revisions?

3. LABEL PRINTING_ETS Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Does the serial number labels appear to have


acceptable printing quality? Print minimum 20 labels
21.130 and verify printing quality stability! Pay especial
attention to the barcode.

21.140 Is "zero slash" turned off (SATO printer)?

21.150 Is the printing balanced/centered on the label format.

Are customer specific labels being correctly printed?


21.160

Is responsibility for label printing quaility defined and is


W/I available for this purpose?
21.170

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 47 of 51
Eltek Supplier Asessment
SUPPLIER TRACEABILITY AUDIT (ONLY VALID FOR CM'S & INT) FINDINGS SUMMARY
Supplier Name: Supplier Representatives: Audit Date: SEVERITY No of Findings

Address: No Compliance/major Issues related to required standards and/or


MAJOR agreements signed by Eltek & Supplier.
Full Compliance/Performing Well References to requirements needed.

City/State/Zip:
Compliance/performing acceptable Partial Compliance/Marginally acceptable with action plan. Issues related
MINOR to required standards and/or agreements signed by Eltek & Supplier.
References to requirements needed.
Country: Eltek Representatives: Partial Compliance/Marginally
Acceptable with Action Plan

Findings related to issues not covered by requirements required by Eltek or


If the finding can't be referred to in agreements/requirements. Can be used
OBSERVATION
No Compliance/Major Issues for Improvement suggestions as well.
NO references to requirements needed.

Is a spare printer or printer head available in order to


21.180
avoid label printing interruption?

Are serial numbers labels reprinted with new revision


code in case a Engineering Change Order has been
21.190
raised instructing such a change (menu: Update Serial
Number Revision)?
DB cleanup: Are all serial number labels NOT being
used being deleted from ETS (menu: Delete Serial
21.200 Numbers)

4. PRODUCTION Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Are products serialized and labeled as early as


possible/needed in order to obtain sufficient
21.210 traceability?

Is the production Start & End clearly identified by


21.220 traveller or other system?
Is the production cycle time registered
21.230

How are component lots registered against assembly?


21.240 By assembly serial number, shop order, time window
or other solution?
For components: How is information about vendor and
21.250 traceability number (i.e. lot, batch number) stored?

How are PCB lots registered against assembly? By


21.260 assembly serial number, shop order, time window or
other solution?
Are solder paste tubes traced?
21.270

Components that are physically in the machine during


production, but not placed to product under work,
21.280 should not be linked to products.

Is "Consist of" registration implemented for all


21.290 products where applicable?

Is the "Predefine" function in ETS being used for all


21.300 "Consist of" registrations?

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 48 of 51
Eltek Supplier Asessment
SUPPLIER TRACEABILITY AUDIT (ONLY VALID FOR CM'S & INT) FINDINGS SUMMARY
Supplier Name: Supplier Representatives: Audit Date: SEVERITY No of Findings

Address: No Compliance/major Issues related to required standards and/or


MAJOR agreements signed by Eltek & Supplier.
Full Compliance/Performing Well References to requirements needed.

City/State/Zip:
Compliance/performing acceptable Partial Compliance/Marginally acceptable with action plan. Issues related
MINOR to required standards and/or agreements signed by Eltek & Supplier.
References to requirements needed.
Country: Eltek Representatives: Partial Compliance/Marginally
Acceptable with Action Plan

Findings related to issues not covered by requirements required by Eltek or


If the finding can't be referred to in agreements/requirements. Can be used
OBSERVATION
No Compliance/Major Issues for Improvement suggestions as well.
NO references to requirements needed.

Are all serialized items included in the #Consist of"


21.310 registration?

Is the "Consist of" registration being done at the right


21.320
time (for best security & efficiency)?

When and why is the "Free Content" function for


21.330
"Consist of" registrations being used?

Is the "Consist of" registration in ETS being updated in


case of change of an serialized item already registered
21.340
(typically during rework after test)?

In case customer specific labels are being used: How


21.350
is correct linking of the serial numbers being secured?

In case Front labels and/or CLEI code labels are being


21.360 used: How is correct linking of the serial numbers being
secured?

How is correct linking of serial numbers secured in


general? Is the Quality Control functionality in ETS
21.370 utilized for this purpose?

DB cleanup: are serial number labels printed for test


21.380 purpose (typically batch number set to TEST) deleted
from ETS? (menu: Delete Serial Numbers)

DB cleanup: is serial number deleted from ETS in case


21.390 of scrapping of an serialized item (menu: Delete Serial
Numbers)

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 49 of 51
Eltek Supplier Asessment
SUPPLIER TRACEABILITY AUDIT (ONLY VALID FOR CM'S & INT) FINDINGS SUMMARY
Supplier Name: Supplier Representatives: Audit Date: SEVERITY No of Findings

Address: No Compliance/major Issues related to required standards and/or


MAJOR agreements signed by Eltek & Supplier.
Full Compliance/Performing Well References to requirements needed.

City/State/Zip:
Compliance/performing acceptable Partial Compliance/Marginally acceptable with action plan. Issues related
MINOR to required standards and/or agreements signed by Eltek & Supplier.
References to requirements needed.
Country: Eltek Representatives: Partial Compliance/Marginally
Acceptable with Action Plan

Findings related to issues not covered by requirements required by Eltek or


If the finding can't be referred to in agreements/requirements. Can be used
OBSERVATION
No Compliance/Major Issues for Improvement suggestions as well.
NO references to requirements needed.

5. WAREHOUSE_SHIPPING Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Are all ETS-serialized items received from other Eltek


21.400 sites registered into ETS (menu: Register Incoming
Goods)

Are all unknown serial numbers (typically third party


21.410 products) being registered in ETS after arrival to the
warehouse (menu: Register Unknown Serial Number)?

Does all single packs for PCBAs have serial number


21.420
label outside according to drawing?

Does all single packs for finished goods have serial


21.430
number labels outside according to drawing?

If applicable, does single packs for finished goods have


21.440
customer specific labels outside according to drawing?

21.450 Is multipack labels implemented for all PCBAs?

Is multipack labels implemented on all finished goods


21.460
with multipackaging solution?

How is the multipack validated before leaving the


21.470
warehouse?

Are all items being registered against a customer order


21.480 before leaving the site (menu: Register Product
Against Sales Order)

Are old customer orders out of date being cancelled


21.490
(register with qty zero)?

6. SERVICE REPAIR Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed

Are all products being registered into the service


21.500
queue?

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 50 of 51
Eltek Supplier Asessment
SUPPLIER TRACEABILITY AUDIT (ONLY VALID FOR CM'S & INT) FINDINGS SUMMARY
Supplier Name: Supplier Representatives: Audit Date: SEVERITY No of Findings

Address: No Compliance/major Issues related to required standards and/or


MAJOR agreements signed by Eltek & Supplier.
Full Compliance/Performing Well References to requirements needed.

City/State/Zip:
Compliance/performing acceptable Partial Compliance/Marginally acceptable with action plan. Issues related
MINOR to required standards and/or agreements signed by Eltek & Supplier.
References to requirements needed.
Country: Eltek Representatives: Partial Compliance/Marginally
Acceptable with Action Plan

Findings related to issues not covered by requirements required by Eltek or


If the finding can't be referred to in agreements/requirements. Can be used
OBSERVATION
No Compliance/Major Issues for Improvement suggestions as well.
NO references to requirements needed.

Is the time from receiving faulty products to


21.510
registration into service queue acceptable?

Have service repair personnel been trained & guided


21.520
in how to use the ETS Service Repair module?

Is use of failure "Class" and "Type" according to the


21.530
ETS guidelines?

Are component references being registered according


21.540
to the ETS Guidelines?

7. TRACING Audit Worksheet Action Plan

No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due Date Date Completed
Are you capable to trace to material source? Can you
trace back to component batch/lot number from top
21.550 level serial number?

Are you capable to trace to current location (inhouse


and customer)? Can you trace forward to top level
serial number from component batch/lot number i.e do
you know in which products the actual component
21.560
batch has been used ?

Do you have a delivery stop process if needed?


21.570

Is there a defined and agreed process to inform


customer if needed?
21.580

8. ETS-Reporter Audit Worksheet Action Plan

Date completed
No. Question Evidence Required Look For Status Severity Finding/Evidence Root Cause Action Responsibility Due date

Have applicable personnel in QA, Warehouse,


Operations and other departments been trained &
21.590 guided in how to use the ETS_Reporter?

Has Manager for service & repair been trained &


21.600 guided in how to use the ETS_Reporter?

Have service repair personnel been trained & guided


in how to use the ETS_Reporter?
21.610

Date: 2016-03-02 Process Owner/Department:


Revision: 7 R. Langtangen / Quality Director/SQM
Doc No: GFORM_270 Approved by:Ø.Larsen/ Director SQM
Page 51 of 51

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