CQI-23

Special Processes: Molding System Assessment

Version 1, 3/2014

Special Process: Molding System Assessment

Facility Name: THAI FUJI SEIKI CO., LTD

Address: 700/721 Moo 3 Amata City Chonburi Industrial Estate Phase 7, T. Bankao , A. Phanthong , Chonburi 20160

Phone Number: 0-3844-7580 -7

Fax Number: 0-3844-7578 -9 Type(s) of Molding Processes at this Facility:
Process Table A
Number of Molding Employees at this Facility: 15 person Injection Molding - O

Captive Molder (Y/N): Y Process Table B

Commercial Molder (Y/N): N Blow Molding -

Date of Assessment: 10 Feb 2023 (TFS Self Audit) Process Table C

Vacuum Forming -
Date of Previous Assessment: N/A for CQI-23 Audit
Process Table D
Compression Molding -

Process Table E
Transfer Molding -

Process Table F
Extrusion -

Process Table G
Equipment - O

Process Table H
Part Inspection & Testing - O

Current Quality Certification(s): IATF16949:2016 , ISO9001:2015

Date of Re-assessment (if necessary): -

Personnel Contacted:
Name: Sirichai Chaikumlop Title: QA MGR Phone: +66-63-386-8625 Email: sirichai@thai.fujiseiki.com

Auditors/Assessors:
Name: Goro Fukuda Company: TFS Phone: +66-63-663-7999 Email: g.fukuda@fujiseiki.com

Number of "Not Satisfactory" Findings: O

Number of "Needs Immediate Action" Findings: O

Number of "Fail" Findings in the Job Audit(s): O

Number of Process Table Items not meeting Minimum Requirements: O

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Special Processes: Molding System Assessment
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Special Process: Molding System Assessment (General Facility Overview)

Assessment

Question Needs Immediate

Question Requirements and Guidance Objective Evidence N/A Satisfactory Not Satisfactory
Number Action

Section 1 - Management Responsibility and Quality Planning

To ensure readily available expertise, there shall be a Yes, Mr. Khomsun (Mold Maintenance
dedicated and qualified molding person on the site. Chief Engineer) and Mr. Vimol (Injection
This individual shall be a full-time employee and the Condition Chief Engineer), They have
position shall be reflected in the organization chart. A experience more than 10 years in
Is there a dedicated and
job description shall exist identifying the qualifications molding operation.
1.1 qualified molding professional
for the position including chemical and molding O
on-site?
knowledge. The qualifications shall include a Evidence:
minimum of 5 years experience in molding operation - TFS Organization
or a combination of a minimum of 5 years of formal - Job Description of Mr. Khomsun &
technical education and molding experience. Mr. Vimol

Yes, we do APQP plan and feasibility

The molder shall incorporate a documented advanced
study. After the part approval process is
quality planning procedure. A feasibility study shall be
approved by Hitachi, no process
performed and internally approved for each new part
changes are allowed unless approved by
or process. Similar parts can be grouped into part
Hitachi.
families for this effort as defined by the molder. After
Does the molder perform
1.2
advanced quality planning?
the part approval process is approved by the
Evidence: O
customer, no process changes are allowed unless
- APQP procedure (10-P-007)
approved by the customer. The molder shall contact
- Feasibility Commitment
the customer when clarification of process changes is
(70-FM-011)
required. This clarification of process changes shall
- Process Change procedure
be documented.
(30-P-004)
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Special Processes: Molding System Assessment
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The molder shall incorporate the use of a documented

Failure Mode and Effects Analysis (FMEA) procedure
and ensure the FMEAs are updated to reflect current Yes, we do follow FMEA procedure.
part quality status. The FMEA shall be written for each FMEA's up to date and reflect current
part or part family or they may be process-specific and processing. We define Process Special
Are the molder's FMEA's up to written for each process. In any case, they shall Characteristics and Product Special
1.3 date and reflecting current address all process steps from part receipt to part Characteristics O
processing? shipment and all key molding process parameters as
defined by the molder. A cross-functional team shall Evidence:
be used in the development of the FMEA. All special - FMEA procedure (30-P-009)
characteristics, as defined by the molder and its - FMEA (30-FM-035)
customers, shall be identified, defined, and addressed
in the FMEA.

The molder shall incorporate the use of a documented

Control Plan procedure and ensure the Control Plans
are updated to reflect current controls. The Control
Plans shall be written for each part or part family or
they may be process-specific and written for each
process. In any case, they shall address all process
Yes, Control plan up to date and
steps from part receipt to part shipment and identify all
refecting currect processing
equipment used and all key molding process
parameters as defined by the molder. A cross-
Are molding process Control Evidence:
functional team, including a production operator, shall
1.4 Plans up to date and reflecting
be used in the development of Control Plans, which
- Process Quality Control Procedure O
current processing? (30-P-011)
shall be consistent with all associated documentation
- Process Quality Control Table
such as work instructions, shop travelers, and FMEAs.
(30-FM-043)
All special characteristics, as defined by the molder
- Control Plan (40-PQ-432)
and its customers, shall be identified, defined, and
addressed in the Control Plans. Sample sizes and
frequencies for evaluation of process and product
characteristics shall also be addressed consistent with
the minimum requirements listed in the Process
Tables.

Are all molding related and
referenced specifications
current and available? For
1.5
example: SAE, AIAG, ASTM,
General Motors, Ford, and
Chrysler.
Are all molding related internal The molder should have a documented process and
1.6 and external best practices
documented and maintained? lessons learned or from industry knowledge.
Is there a written process
1.7 specification for all active
processes?
CQI-23
Special Processes: Molding System Assessment
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To ensure all customer requirements are both
understood and satisfied, the molder shall have all
related molding and customer referenced standards
and specifications available for use and a method to
ensure that they are current. Such standards and
specifications include, but are not limited to, those
relevant documents published by SAE, AIAG, ASTM,
General Motors, Ford, and Chrysler. The molder shall
have a process to ensure the timely review,
distribution, and implementation of all customer and Yes, we follow Hitachi Supplier Manual
industry engineering standards and specifications and
changes based on customer-required schedule. This Evidence: O
process shall be executed as soon as possible and - Hitachi Supplier Manual
shall not exceed two weeks. The molder shall
document this process of review and implementation,
and it shall address how customer and industry
documents are obtained, how they are maintained
within the molder, how the current status is
established, and how the relevant information is
cascaded to the shop floor within the two-week period.
The molder shall identify who is responsible for
performing these tasks.
Yes, we record or documented lessons
learned or industry knowledge
Evidence:
system for maintaining best practices obtained through
- Organizational Knowledge Chart O
- FMEA , Control Plan , WI Operation
The molder shall have written process specifications
for all active processes and identify all steps of the
Yes, we have process specification for all
process including relevant operating parameters.
active processes
Examples of operating parameters include process
temperatures, cycle times, etc. Such parameters shall
Evidence:
not only be defined, they shall have operating
- Injection Condition Standard and O
tolerances as defined by the molder in order to
record
maintain process control. All active processes should
- Material Annealing Standard and
have a written process specification. These process
record
specifications may take the form of work instructions,
job card, start-up sheet, or other similar documents.
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Special Processes: Molding System Assessment
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To demonstrate each process is capable of yielding

acceptable product, the molder shall perform product
capability studies for the initial validation of each
process, after relocation of any process equipment,
and after a major rebuild of any equipment. The
molder shall define what constitutes a major rebuild.
Initial product capability studies shall be conducted for Yes, we do process capability
all molding processes per line as defined in scope of
Has a valid product capability
work and in accordance with customer requirements. Evidence:
1.8 study been performed initially
Capability study techniques shall be appropriate for - SPC procedure (30-P-012) O
and after process change?
the molding product characteristics, e.g., molding - Process Capability Inspection
thickness, part weight, etc. Any specific customer Report (30-FM-049)
requirements shall be met. In the absence of customer
requirements, the molder shall establish acceptable
ranges for measures of capability. An action plan shall
exist to address the steps to be followed in case
capability indices fall outside customer requirements or
established ranges.

The analysis of products and processes over time can

yield vital information for defect prevention efforts.
The molder shall have a system to collect, analyze,
and react to product or process data over time. Yes, we collect and analyze data and
Does the molder collect and
Methods of analysis shall include ongoing trend or react to this data
analyze data over time, and
historical data analysis of special product or process
1.9 react to this data? Are records
parameters/characteristics. The molder shall Evidence: O
available?
determine which parameters/characteristics to include - SPC procedure (30-P-012)
in such analysis. All process control and testing - X Bar-R Chart (30-FM-048)
records must be retained for a minimum of one
calendar year after the year in which they were
created.

Are internal assessments

The molder shall conduct internal assessments on an Yes. TFS conduct internal assessments
being completed on an annual
annual basis, at a minimum, using the AIAG Molding on an annual basis by using TFS Audit
1.10 basis, at a minimum,
System Assessment. Concerns shall be addressed in Check Sheet + the AIAG Molding O
incorporating AIAG Molding
a timely manner. System Assessment Requirement
System Assessment?
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Special Processes: Molding System Assessment
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The quality management system shall include a

documented process for reprocessing that shall
include authorization from a designated individual.
The reprocessing procedure shall describe product
characteristics for which reprocessing is allowed as
No, we do not.
Is there a system in place to well as those characteristics for which reprocessing is
1.11 authorize reprocessing and is not permissible. All reprocessing activity shall require
Evidence: O
it documented? a new processing control sheet issued by qualified
- N/A
technical personnel denoting the necessary molding
modifications. Records shall clearly indicate when and
how any material has been reprocessed. The Quality
Manager or a designee shall authorize the release of
reprocessed product.

Yes, we do.
The quality management system shall include a
Does the Quality Department
process for documenting, reviewing, and addressing
review, address, and Evidence:
1.12
document customer and
customer concerns and any other concerns internal to
- Control of Document and control of O
the molder. A disciplined problem solving approach
internal concerns? Record (10-P-001)
shall be used.

The molder shall define a process for continual

Yes, we do.
improvement for each molding process identified in the
Is there a continual scope of the Molding System Assessment. The
Evidence:
improvement plan applicable process shall be designed to bring about continual
1.13
to each process defined in the improvement in quality and productivity. Identified
- APQP (10-P-007) O
- Quality Objectives Analysis
scope of the assessment? actions shall be prioritized and shall include timing
Improvement & Management
(estimated completion dates). The molder shall show
Review (10-P-006)
evidence of program effectiveness.

Does the Quality Manager or

The Quality Manager or designee is responsible for
designee authorize the
1.14
disposition of material from
authorizing and documenting appropriate personnel to Yes. QA Manager do this O
disposition quarantine material.
quarantine status?

There shall be procedures or work instructions

available to molding personnel covering the molding Yes, we have procedures for molding
process. These procedures or work instructions shall process Management
Are there procedures or work
include methods of addressing potential emergencies
instructions available to
1.15
molding personnel that define
(such as power failure), equipment start-up, equipment Evidence: O
shut-down, product segregation (See 2.8), product - Abnormality Procedure (10-P-005)
the molding process?
inspection, and general operating procedures. These - After Machine Restart Procedure (50-
procedures or work instructions shall be accessible to P-003)
shop floor personnel.
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Special Processes: Molding System Assessment
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Yes, we do follow TFS training system

The molder shall provide employee training for
applicable molding operations. All employees,
Evidence:
including backup and temporary employees, shall be
- Training Procedure (20-P-002)
trained. Documented evidence shall be maintained
Is management providing - WI Operation
1.16
employee training for molding?
showing the employees trained and the evidence shall
- Inspection Standard O
include an assessment of the effectiveness of the
- WS
training. Management shall define the qualification
- PS
requirements for each function, and ongoing or follow-
- Training record
up training shall also be addressed.
- Skill Matrix (20-FM-024)

Is there a responsibility matrix
to ensure that all key
1.17 management and supervisory
functions are performed by
qualified personnel?
The molder shall maintain a responsibility matrix Yes, we do In-house Training and Public
identifying all key management and supervisory Training for all key management and
functions and the qualified personnel who may perform supervisory functions
such functions. It shall identify both primary and O
secondary (backup) personnel for the key functions Evidence:
(as defined by the molder). This matrix shall be readily - In-house & Public Training record
available to management at all times. - Certificate (after pass training)

The molder shall have a documented preventive

Is there a preventive
maintenance program? Is
maintenance data being
1.18
utilized to form a predictive
maintenance program?
maintenance program for key process equipment (as
Yes, we do PM for key process
identified by the molder). The program shall be a
equipment
closed-loop process that tracks maintenance efforts
from request to completion to assessment of
Evidence:
effectiveness. Equipment operators shall have the
- Mold Usage Control (50-FM-058)
opportunity to report problems, and problems shall
also be handled in a closed-loop manner. Company
- Schedule Preventive and Predictive O
Maintenance Plan (52-FM-055)
data, e.g., downtime, quality rejects, first time-through
- Mold Overhaul Record
capability, recurring maintenance work orders, and
- Key process equipment
operator-reported problems, shall be used to improve
Maintenance Record
the preventive maintenance program. Maintenance
data shall be collected and analyzed as part of a
predictive maintenance program.

Has the molder developed a

The molder shall develop and maintain a critical spare
critical spare parts list, and are Yes, we control critical spare part and
1.19
the parts available to minimize
parts list and shall ensure the availability of such parts
have a list of them O
to minimize production disruptions.
production disruptions?
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Special Processes: Molding System Assessment
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Section 2 - Floor and Material Handling Responsibility

Does the facility ensure that
Documented processes and evidence of compliance
the data entered in the
shall exist, e.g., shop travelers, work orders, etc. The Yes, data entered in the receiving
2.1 receiving system matches the
facility shall have a detailed process in place to resolve system matches with Customer's PO O
information on the customer's
receiving discrepancies.
shipping documents?

Procedures for part and container identification help to

avoid incorrect processing or mixing of lots.
Appropriate location and staging within the facility also
help to ensure that orders are not shipped until all
Is product clearly identified
required operations are performed. Customer product
2.2 and staged throughout the
shall be clearly identified and staged throughout the
Yes, please see detail on lot card O
molding process?
molding process. Non-molded, in-process, and
finished product shall be properly segregated and
identified. All material shall be staged in a dedicated
and clearly defined area.

Is molder using adequate

There shall be a procedure that ensures a FIFO Yes, we control FIFO both of material
2.3 FIFO system for material and
system is utilized. and F/G product O
product?

Out-going lot(s) shall be traceable to the incoming

Is lot traceability and integrity lot(s). The discipline of precisely identifying lots and
Yes, we can traceability to the incoming
2.4 maintained throughout all linking all pertinent information to them enhances the
lot O
processes? ability to do root cause analysis and continual
improvement.

The control of suspect or non-conforming product is

necessary to prevent inadvertent shipment or
contamination of other lots. Procedures shall be
Are procedures adequate to
adequate to prevent movement of non-conforming
prevent movement of non-
2.5
conforming product into the
product into the production system. Procedures shall Yes, we keep NCR in Reject Area O
exist addressing proper disposition, product
production system?
identification and tracking of material flow in and out of
hold area. Non-conforming hold area shall be clearly
designated to maintain segregation of such material.

Is there a system to identify
trap points in the entire
process to reduce risk of
2.6
mixed parts (inappropriate,
unfinished or improperly
molded parts)?
Are containers free of
2.7
inappropriate material?
Are operators trained in
material handling, containment including power failure. Training shall be documented.
action and product
2.8
segregation in the event of an types of equipment emergencies and failures shall be Procedure (10-P-012)
equipment emergency
including power failure?
Is the handling, storage and
2.9 packaging adequate to
preserve product quality?
CQI-23
Special Processes: Molding System Assessment
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The molder shall have documented procedures to
identify and monitor trap points for each
process/equipment. Monitoring of potential trap points
Yes, we do for each process/ equipment O
shall occur for every part changeover.
Containers handling customer product shall be free of
inappropriate material. After emptying and before re-
using containers, containers shall be inspected to
ensure that all parts and inappropriate material have Yes, we cleaning tray / containers by dry
been removed. The source of inappropriate material clothes O
shall be identified and addressed. This is to ensure
that no nonconforming molded parts or inappropriate
material contaminate the finished lot.
Unplanned or emergency downtime greatly raises the
risk of improper processing. Operators shall be trained
in material handling, containment action, and product
segregation in the event of an equipment emergency
Work instructions specifically addressing potential Yes, please see Contigency Plan
O
accessible to and understood by equipment operators.
These instructions shall address containment/reaction
plans related to all elements of the process. Evidence
shall exist showing disposition and traceability of
affected product.
The molder's in-process handling and shipping
process shall be assessed for risk of part damage or Yes, we control and check on this matter O
other quality concerns.
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Special Processes: Molding System Assessment
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Plant cleanliness, housekeeping, environmental, and

Are plant cleanliness,
working conditions shall be conducive to controlling
housekeeping, environmental
and improving quality. The molder should evaluate
2.10 and working conditions
such conditions and their affect on quality. A
Yes, we do 5S O
conducive to control and
housekeeping policy shall be clearly defined and
improved quality?
executed.

Process control parameters shall be monitored per

Are process control
frequencies specified in Process Tables. Computer
parameters monitored per Yes, we control parameters monitor
2.11
frequencies specified in
monitoring equipment with alarms and alarm logs
follow Control Plan O
satisfy the verification requirement. A designated floor
Process Tables?
person shall verify the process parameters.

There are documented reaction plans to both out of

Are out of control/specification
control and out of tolerance process parameters.
2.12 parameters reviewed and
There is documented evidence that reaction plans are
Yes, QC Leader review and react O
reacted to?
followed.

Are Test Frequencies

Test Frequencies shall be performed as specified in
2.13 performed as specified in
Process Tables. Refer to Process Tables
Yes, we do O
Process Tables?

Test equipment shall be verified/calibrated per

applicable customer specific standard or per an
applicable consensus standard, e.g., ASTM, SAE,
Is product test equipment
2.14
verified?
ISO, NIST, etc. Verification/calibration results shall be Yes, we do O
internally reviewed, approved and documented.

Refer to Process Tables for frequency of checks.

Lighting in the inspection area shall be sufficient to

allow the evaluation of all part surfaces. The lighting
Yes, we control Lighting of Inspection
2.15 Lighting of inspection area shall be arranged to preclude spot lighting, glare or
area = 1,600 - 3,500 LUX O
shadows. There can be no moving or distracting
reflections on the surfaces to be evaluated.
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Section 3 - Job Audit - Finished Product Review

Job Identity:
Customer: Hitachi Astemo Chonburi Powertrain Ltd
Shop Order Number:
Part Number: FA1320000031L
Part Description: DEFAULT LEVER
Molding Requirements:

Related
Molding System Customer or Internal Job (Shop) Order or Reference Actual Condition Pass / Fail
Question # Job Audit Question
Assessment Requirement Documentation Requirement (Objective Evidence) / N/A
Question #

1.1
Is contract review and advanced quality
1.2
planning, FMEA, Control Plans, etc., in Have document FMEA ,
3.1 1.3 N/A Pass
place and performed by qualified Control Plan
1.4
individuals?
1.6

Does the molder have the proper

3.2 1.5 N/A Product Drawing Pass
customer specifications for the part?

Is there documented evidence of

3.3 2.1 N/A Incoming Inspection Pass
Receiving Inspection?
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Is material identification (part numbers, lot

2.2 Have identify lot no.
numbers, contract numbers, etc.)
3.4 2.3 Material at document PD Pass
maintained throughout the molding
2.4 record
process?

Is the proper procedure or process 1.5

specification used? Refer to Process 1.6
3.5 Tables for specific parameters. List 2.1 QC Flow & Control plan Pass
parameters that were verified in this audit 2.11
in the spaces provided below. 2.13

Process #1:

Process #2:

1.5 Each part may have one or more requirements determined by the molding specification.
What are the product inspection
3.6 2.13 Parts must meet each requirement. List each requirement below and validate.
requirements?
2.14 (Listed below are some examples)

3.6.1 Requirement: Weight

Test Method: Balance Pass

Test frequency or quantity: 1 shot / shift Pass
Selection of samples: Sampling 1 shot / shift Pass
Average weight Die
Specification: Sample +5% Pass
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3.6.2 Requirement: Color

Test Method(s): N/A N/A

Test frequency or quantity: N/A N/A
Selection of samples: N/A N/A
Specification: BLACK Pass

3.6.3 Requirement: Gloss

Test Method: Visual Pass

Test frequency or quantity: 100% check Pass
Selection of samples: 100% check Pass
Not much difference
Specification: compare to Master Pass
sample
3.6.4 Requirement: Flash
Test Method(s): Visual + Microscope Pass
Test frequency or quantity: 1 time / shift Pass
Selection of samples: Sampling 1 shot / shift Pass
Specification: Flash 0.15 Max. Pass
3.6.5 Requirement: Dimension
Test Method: Tool Measurement Pass
Test frequency or quantity: 1 shot / shift Pass
Selection of samples: Sampling 1 shot / shift Pass
Follow Inspection Std. of
Specification: part Pass
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3.6.6 Requirement: Appearance

Test Method: Visual Pass

Test frequency or quantity: 100% check Pass
Selection of samples: 100% check Pass
Specification: Limit Sample Pass
3.6.7 Requirement: Customer Specific
Test Method(s): N/A N/A
Test frequency or quantity: N/A N/A
Selection of samples: N/A N/A

Specification: N/A N/A

Operator or Inspector Responsibilities

1.4
1.6 Document standard is
Were appropriate process steps signed
3.7 2.2 signed by Leader Pass
off?
2.3 /Supervisor/manager
2.11

Were all inspection steps, as documented 1.2

3.8 QC Flow & Control plan Pass
in the Control Plan performed? 1.4

1.2
Were steps/operations performed that
3.9 1.4 Not have Pass
were not documented in the Control Plan?
1.6

1.2
1.4
If additional steps were performed, were
3.10 1.6 N/A N/A
they authorized?
1.10
1.16

Does the governing specification allow 1.5

3.11 N/A N/A
reprocessing or rework? 1.10
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If the order was certified, did the

2.11
3.12 certification accurately reflect the process N/A N/A
2.13
performed?

Was the certification signed by an

3.13 1.16 N/A N/A
authorized individual?

Are the parts and containers free of

3.14 2.6 Yes, not have Pass
inappropriate objects or contamination?

Packaging Requirements

2.6
3.15 Are packaging requirements identified? 2.7 Packing Standard Pass
2.9

Are parts packaged to minimize mixed 2.6

3.16 parts or damaged (for example, work flow 2.7 N/A N/A
or over-pack of container)? 2.9

Shipping Requirements

2.3
3.17 Were the parts properly identified? Lot Card on box Pass
2.9

2.3
3.18 Were the containers properly labeled? Packing Standard Pass
2.9
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PROCESS TABLE A - Injection Molding

All requirements given below are subordinate to customer specific requirements.

The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

*If minimum requirements are not met, provide supporting records to justify actual conditions.

Related
Molding
Observation/
Item # System Category/Process Steps Type of Control Monitoring Frequency
Comments
Assessment
Question #

Minimum Requirement Actual Condition Minimum Requirement Actual Condition (Pass / Fail /
N/A)

1.0 Receiving Inspection

1.4 Incoming material assessment procedure, covering onsite testing or

A1.1 2.1 acceptance of supplier testing, with criteria (i.e., melt flow, specific Manual Manual Once per lot Once per lot Pass
2.13 gravity).

1.4
Incoming components assessment procedure, covering onsite
A1.2 2.1 Manual Not concern part Hitachi Once per lot Not concern part Hitachi N/A
testing or acceptance of supplier testing, with criteria (if applicable).
2.13

2.0 Storage & Handling (If Applicable)

1.4
2.3 Stock rotation system in place for First in/First out (FIFO) and shelf- FIFO - per Lot
A2.1 Automatic/Manual Manual FIFO , Shelf life Pass
2.11 life Shelf life - pull for use
2.12
1.4 Continuous monitoring by
A2.2 2.11 Environment temperature controlled Automatic Automatic controller or manual Manual verification daily Pass
2.12 verification daily
1.4
1.6
Handling of partial containers to ensure no contamination (closed
A2.3 2.7 Automatic/Manual Manual Continuous Continuous Pass
container, clean environment)
2.11
2.12
1.4
1.6
A2.4 2.7 Partial container quantity Automatic/Manual Manual Per Container Per Container Pass
2.11
2.12
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3.0 Material Drying

1.4
Continuous monitoring by Continuous monitoring
A3.1 2.11 Dryer temperature per resin manufacturer guidelines (per material) Automatic Automatic Pass
controller by controller
2.12
1.4
Per Resin Manufacturer Per Material Maker
A3.2 2.11 Dryer time per resin manufacturer guidelines (per material) Manual Manual Pass
Guidelines Guidelines
2.12
1.4
Material change ,
A3.3 2.11 Drying equipment (dryer dedicated or clean procedure in place) Manual Manual Material change Pass
Material filling
2.12
1.4
Continuous monitoring by Continuous monitoring
A3.4 2.11 Dew point Automatic Automatic Pass
controller by controller
2.12
1.4
Control Drying Material
A3.5 2.11 Moisture analysis, if applicable, per Resin Manufacturer Guidelines Manual Manual At start-up and once per shift* Pass
at 140oC (+5oC) , >6 hrs.
2.12

4.0 Recycle (regrind) Material (If Applicable)

1.4
1.11 Recycle ratio (per print, inspection standard or manufacturer Once every 8 hours and at
A4.1 Automatic Not concern part Hitachi Not concern part Hitachi N/A
2.11 guidelines). Verified by feed pressure, weight or volume every part change over
2.13

1.4
1.11
A4.2 Dedicated regrind equipment or cleaning procedure in place Manual Not concern part Hitachi Material change Not concern part Hitachi N/A
2.11
2.12

1.4
1.11
A4.3 Fines management (de-dusting) Automatic/Manual Not concern part Hitachi Material change Not concern part Hitachi N/A
2.11
2.12

1.4
1.11
A4.4 Move regrind to IMM (contamination) Automatic/Manual Not concern part Hitachi Start-up and continuous Not concern part Hitachi N/A
2.11
2.12
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5.0 Color Management

1.4
A5.1 2.11 Pigment blending - percent loading, if applicable Automatic/Manual Not concern part Hitachi Start-up and continuous Not concern part Hitachi N/A
2.12
1.4
A5.2 2.11 Color change procedure Manual Not concern part Hitachi Continuous Not concern part Hitachi N/A
2.12

6.0 Molding Process

1.4
1.15 There shall be a standardized startup procedure/checklist that Start-up and restart after long Start-up and restart after
A6.1 Manual Manual Pass
2.11 defines things to do at start-up down time event stop more than 3 hours
2.12

1.4
1.15 Start-up and restart and after Start-up and restart after
A6.2 Production plan (machine, mold, materials, part style) Manual Manual Pass
2.11 long down time event stop more than 3 hours
2.12

1.4
1.15 At start-up, and after long Start-up and restart after
A6.3 Startup check (verify process settings against setup sheet) Manual Manual Pass
2.11 down time event stop more than 3 hours
2.12

1.4
1.15 Startup check - Secondary Equipment (De-gate, assembly At start-up, and after long Start-up and restart after
A6.4 Manual Manual Pass
2.11 equipment, welders, etc.) down time event stop more than 3 hours
2.12

1.4
Continuous if automatic, or at
1.15 Do each start-up and do
A6.5 Mold surface temperature Automatic/Manual Manual start-up and after down time Pass
2.11 once a day
event
2.12

1.4
1.15 Plastication - Temperature (barrel, nozzle, hot manifold if applicable),
A6.6 Automatic Automatic Continuous Continuous Pass
2.11 screw RPM, and back pressure
2.12
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1.4
1.15 Manual (as condition
A6.7 Plastication - Melt temperature N/A Start-up Start-up Pass
2.11 Std.)
2.12

1.4
1.15 Manual (as condition
A6.8 Plastication - Screw recovery time N/A Continuous Continuous Pass
2.11 Std.)
2.12

1.4
1.15
A6.9 Fill - Screw velocity or velocity profile Automatic Automatic Continuous Continuous Pass
2.11
2.12

1.4
1.15 Manual (as condition
A6.10 Fill - Fill time and peak pressure N/A Continuous Continuous Pass
2.11 Std.)
2.12

1.4
1.15
A6.11 Hold - Hold pressure and hold time Automatic Automatic Continuous Continuous Pass
2.11
2.12

1.4
1.15 Manual (as condition
A6.12 Hold - Cushion N/A Continuous Continuous Pass
2.11 Std.)
2.12

1.4
1.15
A6.13 Hold - Cavity pressure (if applicable) N/A N/A Continuous Not applicable N/A
2.11
2.12

1.4
1.15 Temperature Control Cooling - Coolant inlet temperature and cooling
A6.14 Automatic Automatic Continuous Continuous Pass
2.11 time
2.12
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1.4
Start-up and restart after
1.15
A6.15 Part weight (if applicable) Manual Manual Once every 8 hours* stop more than 3 hours Pass
2.11
and once a shift
2.12

1.4
1.15 Start-up, and restart after Start-up and restart after
A6.16 First piece approval Manual Manual Pass
2.11 down time event stop more than 3 hours
2.12

1.4
1.15 Material purge/evacuation of barrel - included in unplanned and Start-up and End of run
A6.17 Manual Manual End of run or long downtime Pass
2.11 downtime procedures or long downtime
2.12

1.4
1.15
A6.18 Shut down procedures Manual Manual End of production or run End of production or run Pass
2.11
2.12

7.0 Quality Control

1.4 Start-up and once every 4 Start-up and restart after

A7.1 2.11 Part weight Manual Manual hours. For safety critical parts, stop more than 3 hours Pass
2.12 start-up and once every hour and once a shift

1.4
Per cavity, start-up and once Per cavity, start-up and
A7.2 2.11 Dimensions Manual Manual Pass
every 8 hours once a shift and last shot
2.12
1.4
Per cavity, start-up and once Per cavity, start-up and
A7.3 2.11 Appearance (vs. boundary sample or per instruction) Manual Manual Pass
every 8 hours once a shift and last shot
2.12
1.4
Per cavity, start-up and once Per cavity, start-up and
A7.4 2.11 Physical properties (if applicable) Manual Manual Pass
every 8 hours once a shift and last shot
2.12
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PROCESS TABLE H - Part Inspection and Testing

All requirements given below are subordinate to customer specific requirements.

The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to specifications or other
requirements.

Note that not all tests are applicable to all molding processes.

Related
Molding
Item # System Category/Process Steps Monitoring Frequency Observation/Comments
Assessment
Question #

Dimension, Weight, Appearance, Minimum Requirement Actual Condition (Pass / Fail / N/A)

1.0 General

Dimensions

Appearance

Performance

1.4 Procedures are in place to prevent damage to the finish or part during the QA OUT GOING
H1.1 100% Pass
2.9 inspection and packaging processes (30-WI-004)

Appearance (flash, color and gloss, short shots, splay/burns, blister, sink
First off by quality and 100%
H1.2 1.4 marks, gate vestige, and other molding defects) of the molding shall be Operator check 100% Pass
by operator
verified per specification and applications manual

H1.3 1.4 Cracks, Weld line/Knit lines, and Whitening/ stress mark First off and last off Operator check 100% Pass

H1.4 1.4 Part identification First off Operator check 100% Pass

Daily Production Meeting Morning meeting

H1.5 1.4 Manufacturing information Pass
Review everyday

H1.6 1.4 Dimensional check (e.g., Go-no go, Plug and Ring gage) First off and once per shift QC check 1 shift / time Pass

H1.7 1.4 Wall thickness Per process table N/A N/A

H1.8 1.4 General - Weight, Resin, Components, Porosity/Voids (if applicable) First off N/A N/A
 CQI-23
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PROCESS TABLE H - Part Inspection and Testing

All requirements given below are subordinate to customer specific requirements.

The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to specifications or other
requirements.

Note that not all tests are applicable to all molding processes.

Related
Molding
Item # System Category/Process Steps Monitoring Frequency Observation/Comments
Assessment
Question #

Dimension, Weight, Appearance, Minimum Requirement Actual Condition (Pass / Fail / N/A)

H1.9 1.4 Performance Per customer specifications N/A N/A

Test RoHS / SOC

H1.10 1.4 Environmental Per customer specifications Pass
1 time / year
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PROCESS TABLE G - Equipment

All requirements given below are subordinate to customer specific requirements.

The customer may have additional requirements, e.g., inspection testing, greater frequencies, etc. When performing the job audit, the auditor shall verify molder is conforming to customer requirements.

* When historical results show capability, test frequency may be reduced.

Related
Calibration /
Molding System Injection Blow Vacuum Compression Transfer Included in Preventative
Item # Equipment Type Extrusion Verification Frequency Certification Comment
Assessment Molding Molding Forming Molding Molding Maintenance Plan
Frequency *
Question #

1.0 PROCESS EQUIPMENT

TFS Check once per shift and

G1.1 2.14 Mold Temperature Controller X X X X X X Once per shift N/A
PM once per month

Once per month or per

G1.2 2.14 Filters, if applicable X X X X X X N/A TFS PM once per month
preventive maintenance

TFS PM once per month and

G1.3 2.14 Thermocouple X X X X X X Per Preventive Maintenance Annual
calibtration once a year

G1.4 2.14 Injection Mold Machine X Per Preventive Maintenance Every 5 years TFS PM once per month

TFS PM follow Overhaul Mold

G1.5 2.14 Mold X X X X X X Per Preventive Maintenance N/A
Plan

G1.6 2.14 Blow mold machine X Per Preventive Maintenance Every 5 years TFS N/A

G1.7 2.14 Vacuum molding machine X Per Preventive Maintenance N/A TFS N/A

G1.8 2.14 Compression molding machine X X Per Preventive Maintenance N/A TFS N/A

G1.9 2.14 Extrusion machine X Per Preventive Maintenance Every 5 years TFS N/A

G1.10 2.14 Dryer X X X X Per Preventive Maintenance N/A TFS PM once per month

G1.11 2.14 Regrinder X X X Per Preventive Maintenance N/A TFS PM once per month

TFS PM follow Overhaul Mold

G1.12 2.14 Hot Runner Controller X Per Preventive Maintenance N/A
Plan
TFS PM follow Overhaul Mold
G1.13 2.14 Cavity Pressure Sensor X Per Preventive Maintenance N/A
Plan
TFS PM follow Overhaul Mold
G1.14 2.14 Hydraulic Pressure Transducer X X Per Preventive Maintenance N/A
Plan
Valve Gate Controller, if TFS PM follow Overhaul Mold
G1.15 2.14 X X Per Preventive Maintenance N/A
applicable Plan
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2.0 SECONDARY EQUIPMENT

Generic fixtures (cooling, heat

G2.1 2.14 X X X X Per Preventive Maintenance N/A TFS N/A
forming, if applicable)

G2.2 2.14 Conveyers X X X X X X Per Preventive Maintenance N/A TFS PM once per month

G2.3 2.14 Degater/Trim Operation X X X X X X Per Preventive Maintenance N/A TFS N/A

G2.4 2.14 Cutter X Per Preventive Maintenance N/A TFS N/A

G2.5 2.14 Robot X X X X X Per Preventive Maintenance At Installation TFS PM once per month

G2.6 2.14 Oven, if applicable X X X X Per Preventive Maintenance Annual TFS PM once per month

G2.7 2.14 Cooling Fan, if applicable X X Per Preventive Maintenance Annual TFS PM once per month

G2.8 2.14 End of arm tooling X X X X X Per Preventive Maintenance N/A TFS PM once per month

MINIMUM REQUIRED TESTING

3.0
CAPABILITY

G3.1 2.14 Cure Testing, if applicable X X Per lot Annual TFS N/A

G3.2 2.14 Leak Testing, if applicable X X X At start up and per shift Every 6 months TFS N/A

G3.3 2.14 Color X X Before each use Annual TFS one per shift

G3.4 2.14 Gloss X X Before each use Annual TFS one per shift

G3.5 2.14 Weight X X X At start up Annual TFS one per shift

G3.6 2.14 Dimensions X X X X X X At start up Every 6 months TFS one per shift

G3.7 2.14 Moisture X X X X X X Per Manufacturer Guidelines Every 6 months TFS one per shift

G3.8 2.14 Performance, if applicable X X X X X X Per Manufacturer Guidelines Annual TFS one per shift