Internal Audit Process Audit # 19.

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Internal Process Audit Report Page 1 of 4

Business Process: Internal Audit Process

Process Goal and Objective (includes effectiveness and efficiency measures): Audits conducted, Management
review developed, CAPA developed.
Process Input(s):
Quality management system
Process Information

Quality manual
Procedures
Work instructions;

Process Output(s):
Completed documents
QA-F205a, QA-F205b

Departments Involved:
Document Control; Planning/Scheduling; Factory Stores; Factory MRB; Factory Quality; Corporate Quality;
Purchasing

Interactions with other Processes: Product Verification Process Site Document Control Centers; Quality
Planning Process; Customer Service; Planning & Master Scheduling; Purchase Process for Product and Out
Sourced Services; Purchase Product Verification Process FAI/IQA; Material Control Process, MRB Process

Lead Auditor: Enrique Valdez Other Auditor(s): None

Process Owner for process being audited: Daniel Gutierrez Facility: Plant 4A ISO
Audit Date(s): 09/28/2018 Shift(s): 1
Audit information

Standard Clauses/Requirements Addressed:

ISO 9001:2015 + AS9100 – 6, 7.1, 7.1.1, 7.1.2, 7.3, 7.4, 9.2, 9.3.2, 9.3.3, 10.3

IATF 16949 – 5.1.1, 5.1.1.2, 5.1.2, 5.2, 7.1.3.1, 7.2, 7.2.3, 7.3, 8.7, 9.1.3, 9.2.2.1, 9.2.2.2, 9.2.2.3, 9.2.2.4, 9.3.3.1,
10.2, 10.2.3, 10.2.4

ISO 13485:2016 – 5.1, 5.2, 5.,3, 5.4, 5.4.1, 5.4.2, 5.6, 5.6.2, 5.6.3, 6.1, 6.2, 7.2.3, 8.2.2, 8.2.4, 8.3, 8.4, 8.5, 8.5.2,
8.5.3

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 Internal Audit Process Audit # 19.6
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Verify that the process being audited meets these requirements in Management System Manual MS-101:
ISO 9001:2015 + AS9100
6 Planning
7.1 Resources
7.1.1 General
7.1.2 People
7.3 Awareness
7.4 Communication
9.2 Internal Audit
9.3.2 Management review inputs
9.3.3 Management review outputs
10.3 Continual improvement

IATF 16949
5.1.1 General
5.1.1.2 Process effectiveness and efficiency
5.1.2 Customer focus
5.2 Policy
7.1.3.1 Plant, facility, and equipment planning
7.2 Competence
7.2.3 Internal auditor competency
7.3 Awareness
8.7 Control of nonconforming outputs
9.1.3 Analysis and evaluation
Process Procedures

9.2.2.1 Internal audit programme

9.2.2.2 Quality management system audit
9.2.2.3 Manufacturing process audit
9.2.2.4 Product audit
9.3.3.1 Management review outputs- supplemental
10.2 Nonconformity and corrective action
10.2.3 Problem solving
10.2.4 Error-proofing

ISO 13485:2016
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.4.1 Quality objectives
5.4.2 Quality management system planning
5.6 Management review
5.6.2 Review input
5.6.3 Review output
6.1 Provision of resources
6.2 Human resources
7.2.3 Communication
8.2.2 Complaint handling
8.2.4 Internal audit
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
8.5.2 Corrective action
8.5.3 Preventive action

Verify that the process being audited meets the requirements found in these procedures:
131653 Work Instruction Control Procedure
DRC-302NW Offsite Storage of Documents

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 Internal Audit Process Audit # 19.6
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60004-1 QAD Data entry users guide.

DRC-204 Keytronicems records retention program
ENG-201 Procedure for Processing Changes to CDC Controlled Documentation
79016 Electronic File Storage
KTC0005 Document Control Distribution
QA-213 Corrective Action Procedure
MS-101 Quality Management System Policy Manual
QA-205 Internal Audit Procedure
DRC-201 Corporate Document Control Procedure Management System
QA-253 Continual Improvement Process
QA301 The Receipt and Control of Customer Documentation
QA302 Control of External Specifications and Standards
QA314 Preventive & Predictive Maintenance Policy and Program
Data Collection

Individuals Interviewed: Luis Mireles #69581 (ISO engineer), Daniel Gutierrez #64081 (ISO Coordinator), Nancy
Rivas # 44579 (ISO engineer), Carlos Ponce #1552 (ISO engineer), Luz Mota #68263 (ISO Engineer).
Other Process Documents Reviewed (drawings, work instructions, control plans, additional process procedures, etc.):
QA 205 Rev #AO, KTC-QA-F0193a Rev C, KTC-QA-0351 Rev A, KTC-QA-F205b Rev E, QA 242 Rev M, KTC-QA-
Audit Summary

0101 Rev H, Internal audit records, management review record, CAPA system (MQ1), QA-213 Rev. BF.

Strengths:
Excellent Teamwork
Organization
Commitment

Opportunities for Improvement (if assigned preventive action, list CAR #): None.

Nonconformance(s) (list CAR #’s assigned): None.

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Other Audit Notes: None.

This process is effective because (for example, list process metrics being met):
The management review and the Corrective and preventive action process are effective because they were
completed accordance with what is was established in each procedure (MS-210 Rev. C, QA-213 Rev. BF), there is
evidence from the recent and last management review. Also, there were found all the audits being conducted
according with the audit schedule.

Effectiveness Level: 1 The process is – Conforming

[X] 4: Implemented, planned results are achieved (Conforming)

[ ] 3: Implemented, planned results are not achieved and actions to fix are being taken (Partial conformance)
[ ] 2: Implemented, planned results are not achieved and actions to fix are not taken (Nonconforming)
[ ] 1: Not implemented, planned results are not achieved (Nonconforming)

Audit Approval : Daniel Gutierrez (Factory Quality Approval) Date: 09/28/18

Audit Approval : (KTC Corporate QMS Representative) Date:

Revision History
Rev Description Approval Approval Date
A Create form per RFEC # 106641 Gary Kougl L. Bostwick 6/28/11
B Added effectiveness and efficiency measure to process goal per RFEC # 106917 Gary Kougl L. Bostwick 7/19/11
C Added Shift(s) in Audit Information Section per RFEC #228849 B. Jefferson L. Bostwick 11/10/14
D Update document number and change the QA185 to the MS-101 per RFEC #245411 C. Ellis L. Bostwick 4/3/2017
E Update to reverse the effectiveness level ratings per RFEC# 248624 C. Ellis D. Knaggs 9/13/17

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 Process Audit Checklist & Process: (Corrective and Preventive Action)
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Business Management System (BMS) Requirements K Q Observations, Objective Evidence, Notes, and CAR reference
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5.3 Quality Policy (MD)

Is the quality policy understood by personnel involved with the CAPA A Yes, we interviewed Daniel Gutierrez #64081, Nancy Rivas
process? o #44579 and they understood quality policy
Q
k
S
5.4.1 Planning: Quality Objectives (MD)
Have quality objectives and measurements been identified for the CAPA Yes, all these topics are in Management review
A
process? o
Q
k
S
Are the objectives achievable? A Yes, Nancy Rivas showed evidence of completion
o
Q
k
S
Are risks and opportunities considered when the decision is made to not A Yes, all the root cause and addressed by adding the approvers to
o
perform root cause and long term solution? Is this action approved? Q each task
k
S
7.2.3 Internal Communication (MD)
Have communication processes been established to communicate the A Yes, internally is through the Reports weekly by ISO Team
effectiveness of the CAPA process? o showing status and effectiveness and for customer
Q
k communication according to QA-213 Rev. BF Section 4.6.3
S
5.6.2 Review Inputs (MD), 9.3.2 Management Review (QMS)
Has corrective and preventive action data been reviewed with the VP of For top level (VP) used escalation system (see QA-213 Rev. BF
Quality during regular scheduled staff meetings? A Section 4.6.2) to Site Level are reviewed on Management review
o
Q topics
k
Specific corrective actions are not required to be reviewed. S

Have follow-up actions from previous management reviews been Yes, this information is putted into the Management reviewed
reviewed with the VP of Quality during regular scheduled staff A (Site)
o
meetings? Q
k
S

5.6.3 Review Outputs (MD), 9.3.3 Management review outputs (QMS)

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 Process Audit Checklist & Process: (Corrective and Preventive Action)
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Business Management System (BMS) Requirements K Q Observations, Objective Evidence, Notes, and CAR reference
? S

Have corrective actions been issued as needed for QMS elements o A The root cause and long term solutions are reviewed by
reviewed by the VP of Quality during regular scheduled staff meetings? k Q corporate to ensure the actions are adequate as needed
Is the management review recorded? o S
A Yes, the management review is recorded in a binder.
*Check during the audit. k Q
6.1 Provision Of Resources (MD), 7.1 Resources (QMS) S
Have resources been provided to maintain an effective CAPA process? Yes, SW have the ISO team to keep and follow the CAPA
A
o Process and Nancy Rivas is the owner of this activity also the
Q
k owner of the process assigned have the responsibility to
S
implement the actions
6.2 Human Resources (MD)
Based on their education, training and skills are personnel responsible We check this with Yammel (Human resources manager) and
for the CAPA process competent to perform work affecting the A she told us that every candidate need to fill the job description in
o
conformity of product to requirements? Q order to get the job.
k
S

6.2 Human Resources (MD), 7.2 Competence (IATF), 7.3 Awareness (IATF)
Have personnel responsible for answering corrective and preventive A Yes, we checked Nancy Rivas training and we found evidence of
o
actions been adequately trained? Q her training
k
S
Have personnel responsible for the evaluating the effectiveness of o A Yes, all the personnel that evaluates effectiveness has training to
corrective and preventive actions been adequately trained? k Q ensure effectiveness
S
Are personnel aware of the importance of their activities in the CAPA A Yes, all the personnel know the importance and consequences if
process? o not answer correctly
Q
k
S
Are records maintained for all personnel involved in the CAPA process? A Yes, all records are saved in MQ1 System
o
Q k
S
8.3 Control of Nonconforming Product (MD), 8.7 Control of Nonconforming Outputs (IATF)
Are corrective and preventive actions issued for the elimination of Yes, used the methodogies of 5 whys and a long term solution is
detected process non conformances? A implemented
o
Q
k
S

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Business Management System (BMS) Requirements K Q Observations, Objective Evidence, Notes, and CAR reference
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Are corrective and preventive actions issued for the elimination of A Yes, a root cause analysis is conducted and a long term solution
detected product nonconformances? o is implemented
Q
k
S
Do corrective actions for nonconforming product include product re- A Yes, all the product is certificated to ensure the quality
verification to demonstrate conformity to requirements? o
Q
k
S
Do corrective actions for medical devices include documented A Yes this information is part of the DHR
o
concessions or an approved documented rework process as part of the Q
k
containment? S
8.4 Analysis of Data (MD), 9.1.3 Analysis and evaluation (IATF)
Are corrective and preventive actions issued based on customer A Yes, according to QA-213 Rev. BF Section 4.5 Customer
o
feedback, conformity to product requirements and process trends? Q corrective actions
k
S
Are records of data analysis maintained for AQS products and have Yes, all CPR’s are keep into MQ1 System and if not meet the
corrective actions been issued when data does not meet expectations? A expectations are rejected and created a RFI to continue the
o
Q process, based on QA-213 Rev. BF Section 4.5.2
k
S

8.5.2 Corrective Action (MD) , 10.2 Nonconformity and Corrective Action (IATF)
Are corrective actions issued to eliminate nonconformances and prevent A Yes, a root cause analysis is conducted and a long term solution
o
them from recurring? Q is implemented
k
S
Are these corrective actions appropriate to the effects of the o A Yes, the actions are reviewed by approvers who ensure that the
nonconformances? k Q actions are according with the issue.
S
Does the documented procedure adequately define the requirements for Yes, Procedure QA-213 Rev. BF establishes the corporate
the corrective action process? guidelines for the Corrective and Preventative Action (CAPA)
A Program and establishes a system for the consistent
o
Q identification, correction, prevention, oversight, and review of
k
S quality discrepancies as
they affect materials, products, processes, and quality systems.

10.2.3 Problem Solving (IATF)

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Business Management System (BMS) Requirements K Q Observations, Objective Evidence, Notes, and CAR reference
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Is there evidence that problem solving techniques have been used to A Yes, all CPR’s (sample) have loaded the 5 Why’s or 3X5 Why’s
o
identify root causes and long term solutions in corrective actions? Q loaded as common methodologies used but more than one tool
k
S may be used (see QA-213 Rev. BF Section 4.4.1.5)
10.2.4 Error-Proofing (IATF)
Is there evidence that error-proofing methodologies are being utilized in Yes, all CPR’s into MQ1 is used checklist to assure the error
the corrective action process? A proofing before to send to approvals, also QA-213 Rev. BF
o
Q section 4.4.1.10 require these actions
k
S

8.5.3 Preventive Action (MD)

Are preventive actions issued to prevent potential non-conformances? A No Preventive actions, but would be considered as Preventive all
o
Q CPR’s from Internal audit as
k
S
Are the results from preventive actions documented and actions taken? A Yes, all CPR’s are tracking and trending according to QA-213
o
Q Rev. BF Section 4.6
k
S
Is the effectiveness of the preventive actions reviewed? o A Yes, all CPR’s are tracking and trending according to QA-213
k Q Rev. BF Section 4.6
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Business Management System (BMS) Requirements K Q Observations, Objective Evidence, Notes, and CAR reference
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9.2.1 Internal audit(QMS); 8.2.4 (MD); 9.2.1(AS)

Is the organization conducting internal audits at planned intervals to
provide information on whether the quality management system:
a) Conforms to the organization’s own requirements for its quality
management system and the requirements of the ISO 9001:2015
International Standard?
b) Is effectively implemented and maintained?
O A During the internal audit we asked to Carlos Ponce #1552 (ISO
K Q
S
Engineer) she showed us the document KTC-QA-F0193a, Rev.
C that she uses electronically to carry out the internal audit plan,
specifying which plants will be audited, which standards and who
will be the auditors responsible for the audit; making an effective
use and maintenance of the quality management system.

9.2.2 Internal audit (QMS); 8.2.4 Internal audit (MD); 9.2.2 Internal audit (AS)
Has the organization:
a) Planned, established, implemented and maintained an audit
programme, including the frequency, methods, responsibilities, planning
requirements and reporting which takes into consideration the
importance of processes concerned, changes affecting the organization,
and the results of previous audits?
O A The complete plan of internal audits is in the document KTC-QA-
K Q
S
F0193a, Rev. C, clearly describes every standard, plant and
auditor in charge of every audit, the results of the audits are sent
by email to each plant manager, describing findings,
observations and corrective actions if they were found during the
audit.

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Business Management System (BMS) Requirements K Q Observations, Objective Evidence, Notes, and CAR reference
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b) Defined the audit criteria and scope for each audit? A b) Yes, each scope is defined in the document KTC-QA-F0193a
O
Q
K
S
Rev. C
c) Selected auditors and conducted audits to ensure objectivity and c) Yes, the auditors tell us that they would not audit a person in a
impartiality of the audit process? plant and that the person who is in charge of that process.

d) Ensured that the results of audits are reported to relevant
management?
e) Taken appropriate correction and corrective actions without undue
delay?
f) Retained documented information as evidence of the implementation
of the audit programme and the audit results?
d) Yes, the closing meetings that are carried out in each plant,
where they explain everything or that was seen during the audit
and if there was any corrective action.
e) Yes, corrective actions are creating on time, but it is the CAPA
system that manages it and ends completely, reference to the
document QA 205, clause 4.8.
f) Yes, they retain documented information according with the
document DRC-204.

9.2.2.1 Internal audit programme (IATF)

Does the organization have a documented internal audit process? Yes, is the document QA-205, Rev. #AM

Does the process include the development and implementation of an A Yes, have it implemented in document QA-205 Rev. AO, clause
O
internal audit programme? Q 4.3
K
S
Has the internal audit programme cover all quality management system? Yes, in the procedure QA-205, Rev. #AO, clause 4.3.1 says:
Is the audit programme prioritized based upon risk, performance trends, “audit schedules shall be planned taking into consideration the
and criticality of the process? importance/criticality of the processes being audited, risk, internal
and external performance trends, results of the previous audits,
and directives from the management reviews”.

Is the organization including software development capability In the KTC system does not apply the software development
assessments in the programme? capability assessments.

Does the frequency audits is reviewed and adjusted based on Yes, this is explaineds in the procedure QA-205, Rev. #AO, 4.3
occurrence of process changes, internal and external nonconformities, Develop Audit Schedule.
and customer complaints?

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Business Management System (BMS) Requirements K Q Observations, Objective Evidence, Notes, and CAR reference
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9.2.2.2 Quality management system audit (IATF)

Does the organization audit all management systems processes over O A Yes, this information can be found in the document KTC-QA-
K Q
each three-year calendar period to verify compliance with QMS? S
F0193a, Rev. C.

9.2.2.3 Manufacturing process audit (IATF)

Does the organization audit all manufacturing processes over each O A The information was reviewed in document KTC-QA-F0193a,
K Q
three-year calendar period to determine their effectiveness and S
Rev. C which shows the records of the last 3 years calendar
efficiency? period.

Does the organization use customer-specific required approaches for The customer-specific are made depending on the process, and
process audits? verified in floor, but there is not established process yet.

Does the organization have a documented process risk analysis, control Yes, the information is placed on the documents QA-242 Rev. M
plan, and associated documents? and KTC-QA-0101, Rev. H.

9.2.2.4 Product audit (IATF)

Does the organization audit using customer-specific required O A
K Q
approaches at appropriate stages of production and delivery to verify When a customer-specific is required, apply the document KTC-
S
conformity to specified requirements? QA-F0193, Rev C.

7.2.3 Internal auditor competency (IATF)

Does the organization have a documented process to verify that internal O A Yes, both requirements are in the document KTC-QA-0401, Rev
K Q
auditors are competent, taking into account any customer-specific C.
S
requirements?
Does the organization maintain a list of qualified internal auditors?

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Business Management System (BMS) Requirements K Q Observations, Objective Evidence, Notes, and CAR reference
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Does the organization maintain a list of qualified internal auditors? The list of this qualified internal auditors are in the document
KTC-QA-0401, Rev C.
A
O
Are quality management system auditors, manufacturing process K
Q
auditors, and product auditors all able to demonstrate the following S
minimum competencies:

A) understanding of the automotive process including risk-based

thinking;
B) understanding of applicable customer-specific requirements;
C) understanding of applicable ISO 9001 and IATF 16949 requirements;
The quality management system auditors have evidence in
exams and certificates that they understand and apply correctly
all customer-specific, ISO 9001, IATF 16949 and core tools
requirements.

D) understanding of applicable core tool requirements

E) understanding how to plan, conduct, report, and close out audit Yes, the complete work of an audit is carried out following the
findings. document #QA-205, Rev #AO
Do manufacturing process auditors demonstrate techincal O A During the internal audit we asked to Luis Mireles #69581 (ISO
K Q
understanding of the relevant manufacturing process to be audited, S
Engineer) she showed us exams, trainings and certificates about
including process risk analysis and control plan? core tools requirements and IATF Standard.

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Business Management System (BMS) Requirements K Q Observations, Objective Evidence, Notes, and CAR reference
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Do product auditors demonstrate competence in understanding product
requirements and use of relevant measuring and test equipment to verify
product conformity?
O 16949 standard.
K
Where training is provided to achieve competency, is documented
information retained to demonstrate the trainer's competency with the
above requirements?
Is maintenance of and improvement in internal auditor competence
demonstrated through: f) executing a minimum number of audits per
year, as defined by the organization; and g) maintaining knowledge of
relevant requirements based on internal changes and external changes?
Yes, the auditors demonstrate competence by having training
and exams done with reference to core tools, ISO 9001 and IATF
A
Q
S
Yes, all this evidence can be found in the record of each auditor
that retains the training department.
The quality management system auditors are responsible of
check any changes of documentation in the system by e-mail and
the MQ1 system, to ensure each document is with the latest
revision. If any document update is submitted, it’s sent by email
to all interested parties.

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Observations, Objective Evidence, Notes, and CAR
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reference
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ISO 9001, IATF, Medical Devices (13485)

5.1 Management commitment (MD), 5.1.1 Leadership and commitment (IATF), 5.1.1.2 Process effectiveness and efficiency (IATF)
5.1 - Who makes up the Executive and Management Teams? How is O A The effectiveness of the management systems is reviewed
the effectiveness of the management system implemented? K Q through Management Review and is attended by all
S managers staff and Operation director, also daily the
managers take a meeting to discuss all topics of the areas.

5.1 - How are statutory and regulatory requirements communicated to O A All the regulatory requirements are communicated according
the organization? How is it documented? K Q to each product.
S

5.1.1 - What are the Quality, Environmental and Sustainability policies? O A The quality policy is controlled through Management
Are they controlled? K Q Systems Policy Manual MS-101 Rev. BA, and the
S Environmental policy is according with the Environmental,
Health and Safety Policy Manual EHS-101 Rev. L .
agement system measured?

5.1.1 - How are the results of management review communicated to the O A Each manager has the responsibility to communicate the
organization? K Q results of the management review to his work team.
S

5.1.1 - How do Executive and Management Teams determine if O A The managers staff determine the resources needed through
resources are available and adequate? K Q a meeting.
S

5.1.1.2 - How do Executive and Management Teams ensure that O A Through the meet of quality objectives.
product realization and support processes are effective and efficient? K Q
S

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Observations, Objective Evidence, Notes, and CAR
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reference
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5.1.1.2 Process effectiveness and efficiency O A The effectiveness and efficiency is reviewed through internal
K Q audits, also with the achievement of objectives.
S

5.2 Customer Focus (MD), 5.1.2 Customer Focus. (IATF)

5.2 - How are customer requirements determined? How are these O A All the customer requirements are communicated to corp.
requirements documented? K Q However, they have the responsibility to communicated this
S requirements to the corresponding site and to the managers.

5.1.2 - How is product conformity and on-time delivery measured? How O A Through action plans and all these topics are inputs of the
are other customer requirements measured? How are actions taken K Q Management review as metrics
when goals are not met? S

5.1.2 - How does Key Tronic focus on enhancing customer satisfaction? O A This activity is by Corporative, through Score Cards
K Q
S

5.2 Policy (IATF), 5.3 Quality policy (MD)

5.2 - How does top management ensure that the quality policy is O A This activity is through Corporative
appropriate to the purpose of the organization? Are the contents of the K Q
quality policy measurable? S

5.3 - Does the quality policy include a commitment to comply with O A Yes, the quality policy included all these topic
requirements and continually improve the Management System K Q
effectiveness? S

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Observations, Objective Evidence, Notes, and CAR
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reference
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5.3 - Is there an established process to review the quality policy for O A Is reviewed by Managers and Top Management as inputs in
continuing suitability? K Q Management Review – Corporative is responsible to ensure
S this topic according with the procedure Management
Systems Policy Manual MS-101 Rev. BA

5.4 Planning, 5.4.1, Quality Objectives, 5.4.2 Quality management system planning (MD), 6 Planning (QMS)
6.1.1 - Who is responsible to ensure that Key Tronic’s Quality Objectives O A Corporative has the responsibility to established quality
are established at relevant functions and levels? K Q objectives.
S
5.4 - What are the quality objectives for the management system and O A The objectives are Productivity, Quality, Cost, and they are
how are they measured, monitored, and communicated? Are these K Q continually monitored to take actions
objectives documented? S

5.4.1 - What planning is involved in order to achieve the Quality O A Strategic Planning y and developed actions plans
Objectives? K Q
S
5.4.2 - How does Executive Management ensure the integrity of the O A Changes are identified by top management, regarding
Management System when changes are planned and implemented? K Q adequate resources and risk mitigation
S

6.1 Provision of resources (MD), 7.1.1 General (QMS), 7.1.2 People (QMS), 7.1.3.1 Plant, facility and equipment planning
(IATF)

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Observations, Objective Evidence, Notes, and CAR
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reference
? S

7.1.1, 7.1.2 - Does leadership ensure that the appropriate resources are O A Yes, top management provide the necessary resources to
available to support the implementation and maintenance of the QMS? K Q the quality management system.
In cases where internal sources can’t fully support the QMS are external S
providers contracted?
6.1 - Are adequate resources available to ensure customer and O A Yes, top management provide the necessary resources to
regulatory requirements are met? K Q met customer requirements.
S
7.1.3.1 - What kind of methods does the organization has implemented O A This function is performed and covered by HQ during the
to evaluate the manufacturing feasibility for new product or operations? K Q corporate management review.
Are the assessments and manufacturing feasibility include in the S
management review

7.2.3 Communication (MD), 7.3 Awareness (QMS), 7.4 Communication (QMS)

7.4 - How does Management ensure that responsibilities and authorities O A Through policies and procedures described as principle
are defined and communicated within the organization? K Q method of communicating controls.
S
7.3 - How does the organization ensure that employees are aware and O A Link quality objectives and outcomes to the Outcomes to
understand the implications of not conforming to the quality system? K Q bonus program at the operations level.
S
7.3, 7.4 - Please provide examples of responsibilities and authorities O A Intranet sampling of Executive and corporate officer roles
having been communicated through organizational charts, position K Q and Management review records.
descriptions and quarterly employee meetings. Verify that the S
organizational charts are up to date.
7.4 - Is there an organizational chart showing operational responsibility O A Available in Key connection and ISO Drive.
and is it available to all employees? K Q
S
7.2.3 - How does Executive Management establish the interrelation of all O A Through a DHR in each area.
personnel who manage, perform and verify work-affecting quality of K Q
Medical Device programs? S
7.2.3 - How is the performance of the overall management system O A Through the management review and quarterly board
communicated to leadership? K Q meetings.
S

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 Process Audit Checklist & Process: (Management Responsibility)
Objective Evidence Record Audit / File # 18.9 Page _5__ of __8__
O A
Observations, Objective Evidence, Notes, and CAR
Business Management System (BMS) Requirements K Q
reference
? S

7.2.3 - How are customer and regulatory requirements promoted O A Planning, closed loop process, resource allocation and
throughout the organization? K Q Management review for effectiveness.
S
5.6, 9.3, 9.3.1.1, 9.3.2.1 Management review inputs (MD), (QMS), (IATF)
Are all action items from the previous management review closed? If O A Yes, this information was described in “Follow-up actions
not are they on time for completion? K Q from previous management reviews” section in the
S Management Review Meetings 2018.

Is management review scheduled at appropriate frequencies to review O A Yes, quarterly.

the QMS and verify it is in line with the strategic direction of Key Tronic? K Q
S
Have the established quality objectives been met? O A Yes and there were found the graphics in the Management
K Q Review 2018.
S
Does the management review file include information on customer O A Yes, there were found in the Summary (Management Review
satisfaction and feedback from relevant interested parties? K Q Meeting 2018) the section customer feedback and feedback
S from relevant interested parties.

Are resources evaluated for adequacy? If it is determined that resources O A Yes, close loop process.
are not adequate were actions taken or planned to bring in or source out K Q
these resources? S
Is the effectiveness on actions taken to address risks and opportunities O A Measures taken during closed loop process as well as risk
adequate? K Q mitigation efforts to determine adequacy.
S
Are opportunities for improvement identified? Are actions identified to O A Yes, in the management review records there were found a
address these opportunities? K Q section with the improvement actions required.
S

Is the management review conduct at least once a year? O A Yes, during the audit Daniel Gutierrez (ISO coordinator)
K Q showed us the 2018 Management Review records.
S

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 Process Audit Checklist & Process: (Management Responsibility)
Objective Evidence Record Audit / File # 18.9 Page _6__ of __8__
O A
Observations, Objective Evidence, Notes, and CAR
Business Management System (BMS) Requirements K Q
reference
? S

Can you show me the latest management review? O A Yes, there were found evidence of the management at
K Q September 2018.
*Note: Review the requirements on the clause 9.3.2.1 has been meet with the S
management review.

9.3.3.1 Management review outputs. (IATF), 5.6.3 Review inputs. (MD)

9.3.3.1 - Does the organization develop action plans when the when the O A Yes, this activity is through corp.
customer targets are not met? K Q
Can you show me the documents. S

5.6.3 - Does the organization review the decisions and actions taken O A Yes, during the audit Daniel Gutierrez (ISO coordinator)
and keep records of these? K Q showed us the record of Management Review meeting 2018
Can you show me the record of last review output S developed on September.

8.2.4 Internal audit (MD), 9.2 Internal Audit (QMS), 7.2.3 Internal auditor competency (IATF)
8.2.4 - Senior management, during management reviews, shall evaluate O A Yes, this information was described in “Results audits”
the effectiveness and efficiency of the internal auditing process. Please K Q section.
provide evidence of management reviews where the internal auditing S
process was reviewed for effectiveness and efficiency.

7.2.3 - Are auditor competency requirements established? O A Yes, this information is established in the procedure QA-205
K Q Internal Management System Audit Rev. AO “4.4 Auditor
S Competency”

9.2 - Internal audit results are reviewed with the audited departments at O A Yes, they review the results of the audit with the audited
the completion of the audit, how is the department review documented? K Q department through a closing meeting, and they send an
S internal audit report where is described all the issues.

9.2 - Are internal audit results reported to management? In what format O A Yes the internal audit results are reported through the format
are these results communicated? K Q Internal audit report QA-F205b
S

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 Process Audit Checklist & Process: (Management Responsibility)
Objective Evidence Record Audit / File # 18.9 Page _7__ of __8__
O A
Observations, Objective Evidence, Notes, and CAR
Business Management System (BMS) Requirements K Q
reference
? S

8.2.2 Complaint handling (MD)

Are complaints trended and considered an input into CAPA? O A Customer Complaint captured as a distinct category in CAPA
K Q system .
S

Are complaints handled and managed in a timely manner? O A Everything is responded to within 24 hours or less by QA
K Q Corp, MQ1 CAPA system root cause and corrective action.
S

Are records of customer complaints maintained? O A Customer Complaint logged as CPR’s

K Q
S

When complaint product is returned for evaluation, what is the process O A When complaint product is returned a person assigned
to ensure the product is not co-mingled with acceptable product? K Q evaluate the complaint product through the RMA process.
S

When a customer complains what is the process to contain the same or O A Corporate customer complaint handling QA-259 Rev. I
similar product located at Key Tronic? K Q
S

8.5 Improvement (MD), 10.3 Continual Improvement (QMS)

8.5 - What are some examples of current or recently closed projects O A Part of the operations of plant 4 (metal) was relocated to
where changes are made to make improvements to processes, product, K Q plant 5
communication, customer satisfaction, etc.? S
10.3 - Review the management review records. Is continual O A Objectives are expressed as stretch goals and ability to meet
improvement an integral part of this review? Give some examples of K Q is considered continual improvement
improvements. S

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 Process Audit Checklist & Process: (Management Responsibility)
Objective Evidence Record Audit / File # 18.9 Page _8__ of __8__
O A
Observations, Objective Evidence, Notes, and CAR
Business Management System (BMS) Requirements K Q
reference
? S

10.3 - What is the process for determining continual improvement O A QA-253 Rev. L. evidence seen at highest level, Management
projects based on data provided to management review. How are these K Q review records sampled.
projects disseminated and how are they tracked to ensure project S
completion?

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