ISO/TS 16949 Audit Report

ISO/TS 16949 Audit Report

* Example Report *

North America +1-813-252-4770

Latin America

+52-1-333-2010712

Europe & Middle-East +49-8122-552 9590

Asia & Asia Pacific +886-2-2832-2990

Email

[email protected]

www.proqc.com

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The auditor should review the audit results with the supplier, but cannot provide the supplier a copy of the audit. The audit is the property of the client.

CORRECTIVE ACTIONS:It is recommended that the client request a corrective action (improvement plan) based on the results of the audit. The improvement plan should include the following: - Detailed description of action plan. - Name of the person responsible for the improvement activity. - Date when the improvement will be completed.

N/A = Does Not Apply

Non-Conformance = - No objective evidence to support the question (regardless of the procedure). - Lacking some objective evidence and no written procedure.

RESULTS/RECOMMENDATIONS: (Automatically Calculated)The score is based on the percent of questions that Complies with Requirements, percent that Needs Improvement, and the percent that have a Non-Conformance. Each client should review how the supplier was evaluated for each question and base their decisions on factors that are important to their organization and product(s).

AUDIT REPORT:The following sections are completed by the auditor: - Scope of the Audit - Recommendations - Strengths of the Supplier's Quality System and Manufacturing Process - Opportunities for Improvement (Weaknesses in the Supplier's Quality System and/or Manufacturing Process)

RESULTS REVIEW WITH SUPPLIER:

This audit checklist was created based on requirements defined in the following standards:

SCORING:

- ISO/TS 16949 standard

The intent of the audit is to assess the compliance level of suppliers to these requirements, and to provide adequate information to the client for use in business decisions.

- AIAG Standard

GUIDELINE FOR SCORING CONFORMANCE:

Improvement Needed = - Has objective evidence, but procedure needs improvement. - Has objective evidence, but no written procedure. - Has written procedure, but is lacking some objective evidence to support the question.

Each question is assessed for conformance to the requirements of the applicable standards, and the auditors knowledge of the product and/or process This must be clear to the supplier at the opening meeting.

ISO/TS 16949 Quality Management System Audit Rev.GUIDELINES

PURPOSE:

Scores are assigned based on what is done for the Pro QC client regardless of what is done for other clients. For example, if control plans are developed for other clients but not for the Pro QC client, the score must be NC. Scoring must be explained to the supplier at the opening meeting.

Complies with the Requirements = CImprovement Needed = INon-Conformance Found = NC

Complies with Requirements = - Has objective evidence to support the question, and - Has a written procedure (when required).

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NAME : NAME :ADDRESS : ADDRESS :

CITY : CITY :COUNTRY: COUNTRY:

PHONE : PHONE :FAX : FAX :

Mr./Mrs. Title: Email:







92.93%

Category 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT7. PRODUCT REALIZATION6. RESOURCE MANAGEMENT5. MANAGEMENT RESPONSIBILITY4. QUALITY MANAGEM

ENT Complies ( C ) 96.5% 91.67% 88.46% 91.89% 96.77%

Needed Improvement ( I ) 3.5% 7.58% 11.54% 8.11% 3.23%

Not-complies (NC) 0.0% 0.76% 0.00% 0.00% 0.00%

Not Applicable (N/A) 1.8% 12.12% 0.00% 0.00% 0.00%

1

2

3

4This supplier will need significant time and resources to be compliant to requirements. The best solution will be to source another supplier.

and keep pushing them for improvement.System has several major issues noted. You could temporarily use this supplier and

continue business with this supplier.The system is well documented and implemented effectively. You could start or

The system is acceptable, with minor nonconformities noted. You could use this supplier

There are serious majors issues noted with this supplier that could impact your business.request immediate corrective action in case of long-term business.

RECOMMENDATIONS

AUDIT RESULTS =

Pro QC Personnel XXXXXXXXXXXXXX

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ISO / TS 16949 QMS Audit Form Rev.SUMMARY

SUPPLIER'S INFORMATIONXXXXXXXXXXXXXXX

CLIENT'S INFORMATIONXXXXXXXXXXXXXXXXX

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SUPPLIER'S PERSONNEL PARTICIPATING

XX/XX/XXXXAudit Date Report No.

XXXXXXXXXSupplier Name

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0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

7. PRODUCT REALIZATION

6. RESOURCE MANAGEMENT

5. MANAGEMENT RESPONSIBILITY

4. QUALITY MANAGEMENT SYSTEM

Complies)()C))) Needed)Improvement)()I))) Not3complies)(NC))

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To evaluate the Quality Management System of the supplier.

XX/XX/XXXX

Summary / Recommendations:

Scope of Audit:

to requirement of TS, with staff well trained in the maintenance of QMS. The factory has experience working with

The audited factory is located in XXXXXX. The factory has approximately 500 to 600 people working full-time.

Audit Date Report No.

There are two various productions, with one already certified to ISO/TS 16949.Tthe 2nd, XXXXXXXX, is ongoing in the process to be included in this certification before the end of this current year.


There is sufficient evidence demonstrating that the audited site has an effective QMS functioning according

ISO/TS 16949 QMS Audit Rev.AUDIT REPORT

Supplier Name

overcome few improvements listed here below in order to further reduce quality risk.

1. The factory is TS certified, with the system controlled by well qualified people / auditors (12).Strengths:

8. Excellent supplier management / control, with one supplier TS certified, two committed to complete within a couple of

world class track maker and various others clients which has enhanced to keep themselves at the international standard level. The auditor has full confidence that this organization has enough capability to

2. The people in charge of QM has clear understanding of PDCA and have evidences of their implementation.3. Visualizing system to communicate with worker in the clear language of the importance of client.4. Great history of cooperating with major world-class clients. 5. Adequate manufacturing area, well spaced and in good working condition.6. Testing center with necessary equipment in place and calibrated, with tags.7. Multi-functional team applied in the development of process (APQP / PPAP).

8. Calibration: Internal calibration to be traceable to external source.9. Recording: In-house calibration to be recorded by hand, not in the computer.

4. Management review input: Use PFMEA as input during management review meeting.3. Human resources: Must have a replacement staff, when key people are not available.

months, 13 out of 21 ISO 9001 certified.

Opportunities for Improvement:

2. Competence of people: Skill matrix should be defined and published at testing center.

11. Testing method: Could provide specific work instruction for some testing devices with images.12. TS Certification: The organization should submit a plan for the completion of the TS certification of the 2nd facility to client, and keep them updated on the progress.

1. Quality objectives: KPIs should be updated and published on a monthly basis at various workshops.

5. Predictive maintenance: Tool life circle time to be defined in the tooling CV.6. Control of changes: Must specify a list documents that could be affected by specific changes.

10. Calibration: Employees must have a plan when an equipment is found out of calibration or damaged.

7. Calibration: Should have a calibration program with an alert sign when approaching the expiration date.

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SCORE

4

4.1

4.1q1 C

4.1q2a C

4.1q2b C

4.1q2c C

4.1q2d C

4.1q2e C

4.1q2f C

4.1q3 C

4.1q4 C

4.1q5 C

QUALITY MANAGEMENT SYSTEM

Evidences of this question can be demonstrated throughout the audit.

Yes, the organization has established, documented, implemented and maintains a QMS according to ISO / TS requirements (Exclude 7.3), and has evidences of continually improving its effectiveness.

Has the organization identified the processes needed for the QMS and their application throughout the organization? [ISO/TS 16949:2009, Art 4.2.2]

Yes, the organization identified the processes needed for the QMS, in their Quality Manual (Q/YCQP1001-2011, page 14/36), and their application throughout the organization. SEE PHOTO #2.

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ISO/TS 16949 QMS Audit Form

EVIDENCE TO CHECK FINDINGS

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C = Complies with the requirements, I = Improvement Needed, NC = Not Complies, N/A = Not Applicable

Has the organization established, documented, implemented and maintained a QMS and continually improved its effectiveness in accordance with ISO/TS 16949:2009?

Rev.AUDIT CHECKLIST

Supplier Name Audit Date Report No.XX/XX/XXXX

QUESTIONNAIRES

Has organization determined the sequence and interaction of QMS processes? [ISO/TS 16949:2009, Art 4.2.2]

Yes, the organization determined the sequence and interaction of processes in the Quality Manual (Q/YCQP1001-2011, page 15/36). SEE PHOTO #3.

Has the organization defined criteria and methods to uses to ensure that the operation and control of QMS processes are effective?

Yes, the organization applies the approach of PDCA to monitor performance of processes for effectiveness. Each process has procedures and guidelines and with defined KPIs.

Yes, resources are provided, with qualified operators under an organization chart and with adequate two facilities, with necessary equipments. SEE PHOTOS #4, #5 & #6.

Does the organization monitor, measure and analyze QMS processes? (See Section 8)

Yes, each process identified has specific KPI, with responsibility for their monitoring, for improvement, as general KPI and as KPIs distributed to each process and department. It should the status of satisfaction for the year 20XX, and planning for the year 20XX. SEE PHOTOS #7 AND #8.

Does the Organization implemented actions necessary to achieve planned results and continual improvement of processes needed for the QMS?

Has the organization provided resources and information needed to support the operation and monitoring of QMS processes? (See Section 6)

The organization purchases few components from others suppliers, and gets support from external service for calibration of equipment. All of these external outsources are managed according to the requirements of the Purchase Procedure (Q/YCQP2019-2011).

Yes, the Organization has evidences of implementation of continual improvement thought effective management review

Are processes needed for the QMS managed by the organization in accordance with the requirements of ISO/TS 16949:2009?

Yes, processes are managed with KPIs. SEE PHOTOS #7 and 8.

When the organization outsources any process that affects product conformity with requirements, how is control ensured over such processes? (See 7.4)

General Requirements

Where is the control of outsourced processes that affect product conformity with requirements identified within the QMS? (See 7.4)

It is identified in the purchase.

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SCORE

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Rev.AUDIT CHECKLIST


QUESTIONNAIRES

T4.1.1q1 C

4.24.2.1q1a

C

4.2.1q1b

C

4.2.1q1c

C

4.2.1q1d

C

4.2.1q1e

C

4.2.24.2.2q1a

C

4.2.2q1b

C

4.2.2q1c

C

4.2.34.2.3q1

C

Does the quality manual include a description of the interaction between the processes of the QMS? ISO/TS 16949:2009, Art 4.2.2(c)

a) Check if there a document in annex of QM or out of the QM, as document describing interaction between processes. b) Take photo of the map.

Does the organization have the documented procedures required by ISO 9001:2008? ISO/TS 16949:2009, Art 4.2.1(c)

a) Review the procedure master list and confirm that all mandatory procedures are included. b) Take a photo of the master list.

Yes, the factory has about 26 procedures as guidelines for the implementation of QMS according to TS requirements, listed in QM, page 35/36. SEE PHOTO #10.

a) Review where it's written and note the doc, if any. b) Check if the QP/QO posted in a visible place for all employee to view. c) Take a photo.

Yes, the Quality Policy is documented in the Quality Manual (Q/YCQP1001-2011, rev C), published and signed by GM. SEE PHOTO #9. Quality objectives are also listed, with a distribution to each department. SEE PHOTO #7.

Review the Quality Manual, and note the doc. and rev.

Yes, the factory has a Quality Manual 20XX (Q/YCQP1001-2011, rev C) published in 20-09-30.

a) Review the master list for record and confirm that all records monitored are included. b) Take photo of the master list.

Yes, the factory has procedure for the control of record (Q/YCQP2013-2011, Rev. B/0.) There is a master list of ten pages describing all Quality Record to save, including saving place, and time. SEE PHOTO #11.

Check if doc numbers of procedures are written at relevant section of the QM to indicate appropriate procedure applied.

Yes, the QM contains references of procedures/documents to use. The name of the procedures are written as link.

Documentation RequirementsDoes the organization have documented statements of a quality policy (QP) and quality objectives (QO)? ISO/TS 16949:2009, Art 5.3, 5.4.1

If any, is the scope of the quality management system identified in the QMS, including details of and justification for exclusions? ISO/TS 16949:2009, Art 4.2.2(a)

If any justification for exclusions, then note the page of QM in which is written.

Yes, the scope of the QMS is described in the TS certification, with exclusion of 7.3, See page 10/36, where it declared to exclude 7.3, 7.3.2.1, 7.3.3.1.

Does the quality manual (QM) contain or reference the documented procedures established for the QMS? ISO/TS 16949:2009, Art 4.2.2(b)

Are adequate documents in place to ensure the effective planning, operation and control of t organization’s processes? ISO/TS 16949:2009, Art 4.2.1(d)

Evidences of this question could be demonstrated throughout the audit.

Yes, there is process map described in the QM page 14/36, with five Customer related processes (C1, C2, C3, C4), supporting processes, and management processes, including their relation in page 15/36 of the QM. SEE PHOTOS #2 & #3.

Does Organization have a quality manual? ISO/TS 16949:2009, Art 4.2.1(b)

Yes, documentation is visible at each place as guideline.

Does documentation include the records required by ISO 9001:2008? ISO/TS 16949:2009, Art 4.2.1(e)

Does the organization have adequate control over outsourced processes to ensure conformity to all customer requirements? (See 7.4)

Yes, incoming inspections are conducted per random sampling. Suppliers are selected per requirement, and are evaluated on an annual basis.

Quality Manual

Yes, there is procedure for the control of document (Q/YCQP-2012-2011). Checked mold maintenance document (Q/YCQP-3007-01-20XX) distributed in 20XX-03-13, and has signature of related department. Record are written in form (Q/YCQP-4012-02, A/0).

Control of Documentsa) Ask if there is a master list containing all documents for QMS, with doc title, current revision and distribution record / name of users. b) Select few docs from the master list, and cross check on site (user hands) if these docs have same doc. nb, rev. nb, and accurate nb of copy distributed.

Are the documents required by the QMS controlled? ISO/TS 16949:2009, Art 4.2.3

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SCORE

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Rev.AUDIT CHECKLIST


QUESTIONNAIRES4.2.3q2a

C

4.2.3q2f

C

4.2.3q2g

C

C

4.2.3.1T4.2.3.1q1

I

T4.2.3.1q2

C

T4.2.3.1q3

C

Yes, document has OBSOLETE stamp putted in the drawing, SEE PHOTO #12 of drawing Nb. SA14056-D as example.

Is there any evidences of how to easily identify obsolete documents to prevent them for unintended use? ISO/TS 16949:2009, Art 4.2.3

a) Check if there is visible "UNDER CONTROL" stamp on new revised doc, and if there is "OBSOLETE" stamp on old rev. of same doc. b) Note doc. Nb reviewed and take photo of those stamps if any.

Engineering SpecificationsDoes the company have a process to assure the timely review, distribution and implementation of customer specifications and changes?Does it meet customer-required schedule(s)? ISO/TS 16949:2009, Art 4.2.3.1

Yes, the requirement to complete the review and distribution is been defined for two weeks in the (Q/YCQP2012-2011, section 6.8.2)

What records do you have showing implementation dates of changes? Is there evidence showing that documents are updated? ISO/TS 16949:2009, Art 4.2.3.1

a) Check if the company maintains a record of changes in engineering specifications from customers or regulatory or industry documents? b) Randomly select two cases from the list, and ask them to show you record of implementation of such changes in others documents (ie FMEA, Control Plans...etc).

Yes, records are available.

Does the review occur in two weeks or less? ISO/TS 16949:2009, Art 4.2.3.1

Check if the company includes time spent to implement.

a) Ask the responsible to explain how to prevent the use of obsolete documents. b) Check if there is a documented procedure for: - Identification of obsolete doc. - Retention period and location c) Note the doc nb. and current rev. in this report.

Is there a documented procedure that defines the controls needed for prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose? ISO/TS 16949:2009, Art 4.2.3

Yes, there are requirements for the control of external documents (Q/YCQP-2012-2011, step 6.8). There is a master list of external documents written in form (Q/YCQP-4012-07, a/1). An obsolete stamp is putted in the drawing for identification. SEE PHOTO #12.

Is there a documented procedure that defines the controls needed for ensure that documents of EXTERNAL origin are identified and their distribution controlled? ISO/TS 16949:2009, Art 4.2.3

a) Ask for the procedure of document control, and note its doc. nb and current revision in the report. b) Check if this procedure contain clear requirements need for: - Ensuring the legibility and identification - Authorities for approve prior to issue - Ensure that only latest rev. at workplace - Ensure the identification of changes

a) Ask if there is a masterlist containing all documents for QMS, with doc title, doc. Nb. Current revision. And distribution record / name of users. b) Select few docs from the masterlist, and cross check on site (User hands) if these docs have same doc. nb, rev. Nb, and accurate nb of copy distributed.

Yes, the is requirements for the control of external documents (Q/YCQP-2012-2011, step 6.8). There is a masterlist of external document written in form (Q/YCQP-4012-07, a/1). An obsolete stamp is putted in the drawing for identification. SEE PHOTO #12 of drawing Nb. SA14056-D as example.

a) Check if this process is included in any document, note its doc. nb and rev. b) Check if FMEA, Control Plans…etc are included as potential document to review as per customer-required schedule(s).

Yes, the company has a process (SP1) with detail described in the procedure (Q/YCQP2012-2011, section 6.8) for update and timely distribution of updated customer specification and changes. It does not have clarification of what others documents could be affected by specific changes.

Is there a documented procedure that defines the controls needed for approve INTERNAL documents for adequacy prior to issue? ISO/TS 16949:2009, Art 4.2.3

Yes, it described in the procedure (Q/YCQP-2012-2011), step 6.2. The authority regarding document review and approval is defined in the procedure (Q/CYQP-2012-2011, B/0) page 6/6.

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SCORE

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Rev.AUDIT CHECKLIST


QUESTIONNAIRES

4.2.44.2.4q1

C

4.2.4q2

C

4.2.4q3

C

T4.2.4.1q1

C

5

5.15.1q1a

C

5.1q1b

C

5.1q1c

C

5.1q1d

C

5.1q1e

I

T5.1.1q1

C

Have the record requirements been reviewed to ensure conformance with regulatory and customer requirements? ISO/TS 16949:2009, Art 4.2.4.1

Should be reviewed throughout the audit. Review few records at every process to see if there is signature / name of the operator and for the reviewer and approver.

Yes, records are to be review by a supervisor, with signature as conformity.

Should be reviewed throughout the audit. Yes, records are available

Does top management ensure the availability of resources to support and continually improve the QMS?

a) Manpower list at each position b) Machine and facility

The factory does not have a replacement person for lab testing.

What records exist that provide evidence of conformity to requirements and of the effective operation of the QMS? (Should be reviewed throughout the audit) ISO/TS 16949:2009, Art 4.2.4

Yes, the factory has a procedure for management review (Q/YCQP-2016-2011, B/0). The last management review was conducted in 20XX-12-21. There is a form for plan. (Q/HLQP-4016-01)

Does Organization have a documented procedure defining the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records? ISO/TS 16949:2009, Art 4.2.4

Review the procedure and note its doc. nb and current revision.

Yes, the procedure (Q/YCQP2013-2011) provide guidelines for the control of records listed in the masterlist.

Are records legible, readily identifiable and retrievable? ISO/TS 16949:2009, Art 4.2.4

a) Check if the company has a masterlist that with all quality records with detail of: - Name / template nb. - Creation method (handwriting / elec) - Resp. for initiate and approve. - Retention period / location - Saving form (in paper or electronic) - Disposal method after expiration. b) Take photo of the masterlist

The company has a masterlist of records that must be maintained in the factory, with details of their location and retention period, SEE PHOTO #11.

Yes, the factory uses a multi-functional team, with a delegate to supervise the process. Records are available.

Does top management communicate the importance of meeting customer and statutory and regulatory requirements to the organization?

a) Review records (with attendance) of meeting held by top management. b) Review records of meeting related to any new project.

Has company established quality objectives and communicated all members? (See 5.4.1)

a) Check if the quality objectives are hand signed by all managers and published. b) Ask them to explain and demonstrate that quality objectives are aligned to fit with policy.

Yes, quality objectives are also listed, with a distribution to each department. SEE PHOTO #7.

Does top management conduct management reviews? (See 5.6)

Yes, the communication of customer will be communicated to members following the APQP process, to be checked during product/ process realization, with record attached.

a) Check if there a documented as guideline to conduct management reviews, and note the doc. nb / rev. b) Review record of last two management reviews.

Does top management review product realization and support processes to ensure effectiveness and efficiency? (5.6?)

MANAGEMENT RESPONSIBILITY

Control of Records

Management Commitment

Has a company quality policy (QP) been established? (See 5.3)

a) Check if there QP documented, hand signed by top management. b) Check if QP is posted in public board for all employees to view. And, eventually take a photo of it.

Yes, the Quality Policy is documented in the Quality Manual (Q/YCQP1001-2011, rev C), published and signed by GM. SEE PHOTO #9.

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SCORE

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Rev.AUDIT CHECKLIST


QUESTIONNAIRES

5.25.2q1

C

5.35.3q1a

C

5.3q1b

C

5.3q1c

C

5.3q1d

C

5.3q1e

C

5.4

5.4.15.4.1q1

C

5.4.1q2

C

T5.4.1.1q1

C

5.4.25.4.2q1a

C

Is there an established process to review the quality policy for continuing suitability?

Yes, from management review meeting.

Are the contents of the quality policy relevant to the organization and measurable?

Read the quality policy and ask them to explain how the company measures them.

Yes, the contents of the quality policy relevant to this factory are measurable with KPIs defined, SEE PHOTOS #7 AND #8 for the year 20XX. There is plan of how these KPIs are monitored. SEE PHOTO #8.

Is the quality policy communicated and understood within the organization?

a) Check if there is QP documented and hand signed by top management. b) Check if QP is posted in public board for all employees to view.

Yes, the Quality Policy is documented in the Quality Manual (Q/YCQP1001-2011, rev C), published and signed by GM, posted in published place visible by all. SEE PHOTO #9.

Does top management ensure that the quality policy is appropriate to the purpose of the organization?

Read the quality policy. Yes, the quality policy is well appropriate, and applicable to their facility.

Does the quality policy include a commitment to comply with requirements and continually improve QMS effectiveness?

Read the quality policy. Yes, the quality policy includes a commitment to comply with requirements and continually improve QMS effectiveness.

Yes, the company has nominated a responsible party to act as Customer Rep. with responsibility to ensure that customer requirements are determined. SEE PHOTO #13. (Q/YCQP1001-2011, page 5/36). The factory also maintains a record describing all customer requirement records. (Q/YCQP-4003-32-2012) SEE PHOTO #14.

Customer Focus

Has top management established quality objectives (including those needed to meet requirements for product) at relevant functions and levels within the organization?Are the quality objectives consistent with the quality policy? What are the measurements?

a) Ask them to explain how quality objectives are aligned to fit with quality policy. b) Review record of measurement of last year, and for this year. c) Check if the result are published and take a photo of quality objectives.

Yes, the quality objectives are consistent with the quality policy. SEE PHOTO #8.

Are quality objectives and metrics included in the business plan?

Check if the quality objectives are hand signed by all managers and published.

Yes, it is included. SEE PHOTO #8.

Does the company ensure that the planning of the QMS is carried out in order to meet the requirements given in ISO /TS 16949:2009 section 4.1, as well as the quality objectives?

Check if the quality objectives are hand signed by all managers and published.

Yes, quality objectives are also listed, with a distribution to each department. SEE PHOTO #7.

Quality Management System Planning

Planning

Quality Objectives

Has top management ensured that customer requirements are determined and met with the aim of enhancing customer satisfaction?

a) Check if there is any responsible person or group dedicated for identification of customer requirements. b) Check if there any records showing a list of identified requirements per customer, and related procedures or method applied to fit them.

Quality Policy

Yes, the factory uses the strategy of internal audit, process audit, and product audit to monitor the effectiveness of QMS as input for management review.

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SCORE

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Rev.AUDIT CHECKLIST


QUESTIONNAIRES5.4.2q1b

C

5.5

5.5.15.5.1q1

I

T5.5.1.1q1

C

T5.5.1.1q2

C

T5.5.1.1q3

C

5.5.25.5.2q1

C

5.5.2q1a

C

5.5.2q1b

C

5.5.2q1c

c

T5.5.2.1q1

C

T5.5.2.1q2

C

Is there a ISO/TS 16949 Management Representative (MR)?

Yes, there is an Organization Chart in the Quality Manual (Q/YCQP1001-2011, page 6/36) and detail of job description in pages 8/36, 9/36. However, there is no document detailing replacement people in the event of the absence of a key person, for example at the Testing Center.

Are managers responsible for corrective action informed of nonconforming products or processes?Are they informed in a timely manner?

Do personnel responsible for product quality have the authority to stop production to correct quality problems?

Yes, it documented in the QM, page 4/36. Mr. XXX is nominated as Management Representative.

Review JD for Quality Manager / Supervisor and check if this is included.

Does their responsibility and authority include selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development?

Review JD for customer representative and check if this is included.

Yes, it is included.

Yes, it is defined in the QM, page 5/36.

Are responsibilities and authorities defined and communicated within the organization? (Verify throughout audit)

a) Check the organization chart and take photo. b) Check if there is detailed job description for every position within the organization. c) Check if there is a planning for replacement in the absence of key person, and related training record / qualifications.

a) Review the organization chart and the position of MR, including report line. b) Review his last report submitted to top management (Is this signed by the MR?)

a) Check if there a document that describes the flow for the communication of quality issues, and note the doc. nb / rev. b) Check if a record of internal / external complaints are maintained.

Responsibility and Authority

Yes, it is implemented accordingly and records are available.

Yes, following the procedure (Q/YCQP2010-2011), with responsibility under Manager of Technical Department.

Yes, it is defined in the JD of the Quality Department, No. 9.

Has top management designated as Customer Representative to ensure that customer requirements are addressed?

Does the MR have the responsibility to ensure the promotion of awareness of customer requirements throughout the organization?

Review JD for MR, and check if this is included. Yes, it is included.

Responsibility, Authority and Communication

What personnel on each shift have responsibility for ensuring product quality?

Check if there is a representative of the Quality Department in charge of quality for the whole company. Note his/her name.

Check if there is nomination letter and take photo.

a) Check if there is a document as guideline to handle any changes that could potentially happen, note doc. nb / rev. b) Check if the company has a reaction plan with responsible for implementing changes.

Check if there is nomination letter, take photo of that letter.

Does the MR have the responsibility to report to top management on the performance of the QMS and any need for improvement?

Management Representative

Does the MR have responsibility and authority to ensure that processes needed for the QMS are established, implemented and maintained?

Review JD for MR and check if this is included.

Yes, each facility under this organization has responsibility of quality to ensure the quality of product.

How do you ensure that the integrity of the QMS is maintained when changes to the QMS are planned and implemented?



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QUESTIONNAIRES

5.5.35.5.3q1

C

5.65.6.1q1

C

5.6.1q2

C

5.6.1q3

C

T5.6.1.1q1

C

T5.6.1.1q2

C

T5.6.1.1q3

C

5.6.25.6.2q1

C

T5.6.2.1q1

I

5.6.35.6.3q1

C

What is the frequency that top management reviews the organization's QMS?

Review OutputWhat decisions or actions have resulted from management reviews for each of the following?a) improvement of the effectiveness of the quality management system and its processesb) improvement of product related to customer requirements, andc) resource needs

a) Verify if there is document specifying the type of output for the management review, note the doc. nb/ rev. b) Verify if all mandatory outputs are listed, and with evidences for the last 2 management review meeting.

Review input

Check records of last two management reviews and compare status of improvement between both.

Management ReviewCheck if it documented to conduct management review at least one time per year and in specific circumstances. Note the doc. nb / rev.

It is written in the procedure that the management review will be conducted one time per year.

How is information regarding the effectiveness of the QMS communicated within the organization?

a) Check if the company has defined clear methods (email, fax, telephone, meeting, paper record) for communication of information. b) Check if the implementation of these are effective and their efficiency monitored (On time delivery, accuracy).

The method of communication is defined in related procedure, and change depending to the type of information. Email, ERP system mainly is used, including public board, to inform about performance. SEE PHOTO #15.

Can you show me records from recent management reviews?

Yes, reviewed the record of last management review conducted in 20XX-12-22.

Can you show management review records including monitoring of quality objectives, and cost of poor quality metrics? (Verify records)

Verify records of last two management review.

Verify records of last two management reviews. Record of review are checked for the year 20XX. Performance trends of the year 20XX recorded in document ( Q/YCQP-4016-05, B/0).

Can you show records providing evidence of achievement of the quality objectives specified in the business plan, and customer satisfaction with product supplied?

Verify records performance of each objectives and take photo.

Can you show me that each of the following were included in review(s)?a) results of audits,b) customer feedbackc) process performance and product conformityd) status of preventive and corrective actionse) follow-up actions from previous management reviewsf) changes that could affect the quality management system, andg) recommendations for improvement

Yes, decision of output are listed in the form Q/YCQP-4026-02 (a/0).

What kinds of information are reviewed in management reviews? (Must include suitability, adequacy and effectiveness of QMS; improvement; & changes to the QMS, quality policy and objectives)

Check the scope of management review suitability, adequacy and effectiveness of QMS; improvement; & changes to the QMS, quality policy and objectives.

According to the last management review conducted in 20XX-12-21, following are reviewed written in Q/YCQP-4016-03 (a/0): - Policy and objective - Last internal audit record - Improvement opportunity

Record are available. SEE PHOTO #16.

Yes, recorded in the form Q/YCQP-4016-05, B/0)

Do management reviews include all requirements of the quality management system and performance trends? (Verify records)

Do records show input to management review includes analysis of actual and potential field-failures and their impact? (See also 7.3.4.1)

Did not include PFMEA as input to management review.

a) Verify if there is document specifying the type of input for the management review and note the doc. nb/ rev. b) Verify if all mandatory inputs are listed, and include evidences for the last two management review meeting.

Yes, all inputs are included in the file Q/YCQP-4016-03 (a/0).

Internal Communication

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QUESTIONNAIRES

6

6.26.1q1a

C

6.1q1b

C

6.3

6.2.16.2.1q1

C

6.2.26.2.2q1a

C

6.2.2q1b

C

6.2.2q1c

C

6.2.2q1e

C

T6.2.2.1q1

C

T6.2.2.1q2

I

T6.2.2.2q1

C

RESOURCE MANAGEMENT

The factory has procedure (Q/YCQP2017-2011) for guideline for the identification of training. Training are for new hiring people and for annual training.

What are the education, training, skills and experience required by this job/task? How does this person meet those qualifications?

Training of technical people has been planned in the document (Q/YCQP-4-17-14-2012) for the current year, for Autocad, GB2828, ERP system, SEE PHOTO #28. No record to attest the capability of employee having skill in PRO / E. for example.

The method of evaluation is defined in the file (Q/YCQP-4017-14-2012). SEE PHOTO #26.

a) Verify if there is method for evaluating effectiveness of training provided, and name of examiner. b) Verify of the trainer is the same peron that conduct evaluation.

When you provide training or other actions to satisfy competence needs, how do you evaluate the effectiveness of those actions? (records)

How do you determine the necessary education, training, skills and experience for people performing work affecting product quality?

The factory has defined skill matrix for each level of employee, documented in the file (Q/YCQP-4017-14-2012). SEE PHOTO #24.

Verify if the factory has system for identification of training need.

Select three training topics from the training program, and verify if related training records are available and fit with the program.

Yes, records are available. SEE PHOTO #27.

What records do you have showing that product design personnel are competent to design and are skilled in the identified tools and techniques?

The factory has identified specific design software such as PRO / E, Autocad and solid work.

Verify design personal skill matrix and related certificate / training record.

What training or other actions do you provide to satisfy the needs of personnel?

What tools and techniques has the organization identified as necessary for product design personnel?

a) Verify if Autocad, Pro/E…ERP system or any similar system is applied for design personnel. b) Note revision number of those design tools.

Can you show me documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting product quality?

Check the existence of the procedure, and note doc. nb / rev.

Yes, the record of training are available in the document (Q/YCQP-4017).

Where do you maintain records of education, training, skills and experience?

a) Verify if a periodical (annual) training plan is documented. b) Take a photo of the training program.

There is an annual training program documented in the file (Q/YCQP-4017-14-2012) for the year 20XX, and approved by the leader in 20XX-01-07. SEE PHOTO #25.

Provision of Resources

What resources has the organization provided to ensure that customer requirements are met?(See 6.2, 6.3, 6.4)

Evidence on question (See 6.2, 6.3, 6.4) will be acceptable.

The factory has all necessary workshops, and equipment, including lab service. SEE PHOTOS #5, #6, AND #17. TESTING CENTER - SEE PHOTOS #18, #19, #20, #21, #22.

General

Competence, Awareness and Training

What resources has the organization provided to implement and maintain the QMS and continually improve its effectiveness?

Review factory profile. The factory provided manpower resource for the QMS, and ERP system for internal communication, etc.

Human Resources - General

a) Verify of the factory has skill matrix defined for key personnel. b) While auditing, select some personnel performing work affecting product quality.

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QUESTIONNAIREST6.2.2.2q2

I

T6.2.2.3q1

C

T6.2.2.3q2

C

T6.2.2.4q1

C

T6.2.2.4q2

C

T6.2.2.4q3

C

6.36.3q1a

C

6.3q1b

C

6.3q1c

C

6.3.1T6.3.1q1

C

What process has been established to measure the extent to which personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives?(See 6.2.2d)

What groups are involved in developing plant, facility and equipment plans?(Must be multidisciplinary)

Verify if there is map route describing position of machine, storage of material, moving of people.

What supporting services (such as transport or communication) are needed to ensure that product meets requirements? How are they maintained?

Listed in the factory profile and take photos. Yes, the factory use automatic conveyor at the painting process.

The maintenance department is in charge of this. There is visible map route and layout at each workshop. SEE PHOTO #35.

a) Visit the facility, specially the condition of how product / material are stored. b) Verify if the factory has a maintenance program.

Yes. SEE PHOTO #5, #6 & #17.Are the buildings, workspace and utilities provided appropriate to achieve conformity to product requirements? How are they maintained?

Plant, Facility and Equipment Planning

a) Any promotion activities? b) Employee satisfaction survey and record? c) Are KPIs published at each workplace for employee to review?

1. Salary increase of 10% to 15% 2. KPIs are published on site. 3. Employee satisfactory survey (Q/YCQP 4021-05) conducted in 20XX-11-20, and summarized in Q/YCQP4021-06.

Does the process include the promotion of quality and technological awareness throughout the whole organization?

a) Is the promotion documented and communicated ? b) Any evidence records for quality / technological?

By meeting, and posting of process files on site as work instruction and red sign on specify product/process characteristic. SEE PHOTOS # 29 & #30.

Infrastructure

What kinds of on-the-job training do you provide for people in new or changed jobs? Does this include contract and agency personnel?

Review the records, if any.

What kind of process equipment (both hardware and software) is necessary to conform to product requirements? How is the equipment maintained?

Listed in the factory profile, take photos. Yes, for client, only need an assembly line. SEE PHOTOS #32, #33 & #34. The factory also has a stamping workshop. SEE PHOTOS #5 & #6.

Yes, a promotion is planned to enforce quality and technological awareness throughout the whole organization. SEE PHOTO #31.

What records do you have that personnel performing specific assigned tasks are qualified - especially to meet customer requirements? (See 6.2.2e)

a) Verify record of training / certificate of personnel performing key process (for example). b) Verify record of training / certificate of personnel for specific client requirement, note the specific client is possible.

Training of technical people has been planned in the document (Q/YCQP-4-17-14-2012) for the current year, for Autocad, GB2828, ERP system. SEE PHOTO #28. No record to attest the capability of employee having skill in PRO / E, for example.

Record of training are available. Contract and agency are not used in this factory.

How do you inform personnel about the consequences to the customer of nonconformity to quality requirements? (Sample throughout organization)

Select a few workers at the manufacturing area, and ask them to show the defect part and explain the consequence of this defective part.

What process has been established to motivate employees to - achieve quality objectives- to make continual improvements, and- to create an environment to promote innovation

a) Is there any questionnaire test for employee to evaluate their knowledge?

Yes, there is questionnaire test applied as part of test exam. SEE PHOTO #26.

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QUESTIONNAIREST6.3.1q2

C

T6.3.1q3

C

6.3.2T6.3.2q1

C

6.46.4q1

C

T6.4.1q1

I

T6.4.2q1

C

7

7.17.1q1

C

7.1q2

C

7.1q3a

C

7.1q3b

C

Verify if there a process map or flow chart for product realization and note doc nb / rev.

Can you show that plant layouts optimize material travel, handling and floor space use, and facilitate synchronous material flow?

a) Is the pathways visible defined for material storage, machines position and peoples rotation? Take photo. b) Is the direction of moving clearly marked?

Where in the product realization process do you determine the quality objectives and requirements for products?

a) Verify if the step for the identification of product requirements are planned. b) Check if there a record as example of any product.

Yes, it planned, as for example of the development of product / project #198911-E. SEE PHOTO #36. The identification is planned with the output recorded in the form (Q/YCQP-4003-32-2012).

The planning of production realization is documented as project planning such as for the case of project #198911-E. SEE PHOTO #36.

Yes, the guidelines are described in the procedure (Q/YCQP2004-2011), under responsibility of production department.

Is the planning of product realization consistent with the requirements of the other processes of the QMS? Verify there are no inconsistencies or conflicts between quality system procedures.

Check the relation between this process with others process. Define where it gets input and where its output goes.

Defined with previous process as marketing dev, order review, product development, and with next process as continuous improvement.

Record of periodical evaluation of time used to move material from this location to another place, a long a certain pathway.

With periodical evaluation of each process.What methods are used to evaluate and monitor the effectiveness of existing operations?

Are the processes needed for product realization identified?

When planning for product realization, how do you establish processes, documents, and provide resources specific to the product?

a) Verify if there is planning. b) Check if there a record as example of any product.

Yes, it is clean and well organized at the stamping plant and assembly plant.

How are product safety and potential risks to employees addressed by the organization?

Each machine has user manual visible. Could better be written with images that indicate what to do when using it, both at workshop and testing center.

Yes, there is contingency plan for labor shortage, key equipments failure…etc.

Yes, the plant layouts optimize material travel, handling and floor space use, and facilitate synchronous material flow. SEE PHOTOS #5 & #6.

Has the organization defined the adequate work environment required to achieve conformity to product requirements? How is this environment managed and maintained?

a) Verify is adequate temperature / humidity, noise, odors, cleanliness, lighting, etc. are defined as basic condition for work environment. b) Verify if those conditions are checked and recorded.

Yes, as required in the procedure. (Q/YCQP2018-2011)

Can you show contingency plans for each of the following?- Utility interruptions- Labor shortages- Key equipment failure(s)- Field returns

a) Verify if there is a documented plan to handle sudden short down in the planning, take photo of the plan. b) Ask if such situation happen, and what was the impact. c) Does the contingency plan describe responsibility?

Work Environment

Planning of Product Realization

Does the organization maintain the state of order, cleanliness and repair needed for products and manufacturing processes? (Verify throughout audit)

PRODUCT REALIZATION

Contingency Plans

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QUESTIONNAIRES7.1q3c

C

7.1q3d

C

7.1q4

C

7.1.1T7.1.1q1

C

7.1.2T7.1.2q1

C

T7.1.2q2C

7.1.3T7.1.3q1

C

7.1.4T7.1.4q1

C

T7.1.4q3

C

T7.1.4q5

C

7.2

7.2.17.2.1q1a

C

7.2.1q1b

C

7.2.1q1c

C

Where are acceptance criteria defined? When required, does the customer approve them?

Check a record of such acceptance criteria, and check if there is an evidence that it was approved by the customer.

Acceptance criteria are defined for each stage as guideline to accept the completion of each stage

Yes, the acceptance level zero defects is applied.

Changes that happen during process development are monitored according to guidelines detailed in the procedure. (Q/YCQP-2003-2011)

Are changes validated before implementation?

When attribute data sampling, is the acceptance level zero defects?

Check the inspection criteria.

What process is there to control and react to changes that impact product realization?

Planning of Product Realization – SupplementalDoes the quality plan include customer requirements and reference to technical specifications?

Review the quality plan Yes, it included, example of the project #198911-E

What are the outputs of product realization planning? Are they in a form suitable for the organization?

Verify if there a documented planning.

How does the organization ensure the confidentiality of customer-contracted products, projects under development, and related product information?

Yes, changes re-validated by a group of team members before to process.

Determination of Requirements Related to the Product

Do you have evidence that any additional verification/identification requirements required by the customer are met?

By customer property (Q/YCQP2005-2011).

Change Control

How do you determine verification, validation, monitoring, inspection and test activities specific to the product, and the criteria for product acceptance?

Yes, forms are used to record output of the product realization.

Does the organization determine requirements specified by the customer, including the requirements for delivery and post-delivery activities?

Yes, the organization determines requirements specified by the customer, including for delivery and PPM, as required by the procedure (Q/YCQP3001-2008) and document them in (Q/YQCP-4003-32-2012). SEE PHOTO #14.

Customer-Related Processes

What records exist showing that both the realization processes and the product meet requirements?

Check if there a record as example of any product.

Records of the four stages are available, example of the project #198911-E.

a) Verify if there is planning defining method for verification, validation…etc. b) Check if there a record as example of any product.

The stage of verification, validation and monitoring of production realization are documented as project planning such as for the case of project #198911-E. SEE PHOTO #36.

Acceptance Criteria

Confidentiality


Yes, it included in the document (Q/YQCP-4003-32-2012). SEE PHOTO #14.

Does the organization determine statutory and regulatory requirements related to the product?

Yes, it is included in the document (Q/YQCP-4003-32-2012). SEE PHOTO #14.

Does the organization determine not stated by the customer but necessary for specified or intended use, where known?

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QUESTIONNAIRES7.2.1q1d

C

T7.2.1.1q1

C

7.2.27.2.2q1a

C

7.2.2q1b

C

7.2.2q4

C

T7.2.2.2q1

C

7.2.37.2.3q1

C

C

7.3

7.3.17.3.1q1

C

7.3.1q2a

C

7.3.1q2b

C

7.3.1q2c

C

Design and Development PlanningCan you explain to me the process used by the organization to plan and control the design and development of product?

There is a procedure Q/YCQP-2003-2011 for development of process according to APQP / PPAP.

According to change procedure. There are a few examples of how changes were implemented.

What method(s) are used to communicate with customers regarding - product information- enquiries, contracts, or order handling including amendments?- feedback, including customer complaints

Procedure (Q/YCQP2021-2011), via customer representative.

What documents do you have that show investigation and confirmation of manufacturing feasibility in the contract review process for proposed products, including risk analysis?

Yes, there are few case where feasibility were conducted.

How do you ensure that product requirements are defined and reviewed before committing to supply product?

Design and Development

The procedure Q/YCQOP-2003-2011 is been developed to required a mandatory step to conduct the feasibility before launching the project.

Does the organization determine any additional requirements determined by the organization.

When product requirements are changed, how do you ensure that relevant documents are changed and that relevant personnel are made aware of the changes?

Review of Requirements Related to the Product

Does the organization meet customer requirements for designation, documentation and control of special characteristics?

Yes, all requirements are meet according to the PSW signed by CVGS.

What kind of review is done to ensure that the organization has the ability to meet requirements before committing to supply product?

A feasibility review is conducted involving all departments, and each department will review product requirements and sign to conform that they have the capability to meet client requirements.

Yes, it is included in the document (Q/YQCP-4003-32-2012). SEE PHOTO #14.

Do your customers require information to be communicated in specific languages and/or formats? If so, how do you meet those requirements?

Yes, specific format to use, and in English must of the time. The factory has people with English capability, such as Ms. XXX, the Customer Rep.

Customer Communication

What are the stages in the design and development process?

There are four stages for the development, for example of the project CVGS (OEM), for part 198911-E, the plan is documented in Q/YCQP4003-04.

Are the review, verification and validation activities appropriate to each design and development stage planned?

Yes, there are review, verification and validation at each stage. Example of part 198911-E, the plan is documented in Q/YCQP4003-04.

Are design and development responsibilities and authorities defined?

Yes, responsibility is well defined. Example of part 198911-E, the plan is documented in Q/YCQP4003-04.

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QUESTIONNAIRES7.3.1q3

C

T7.3.1.1q1

C

7.3.27.3.2q1a

N/A

7.3.2q2

N/A

7.3.2q3

N/A

7.3.2.1T7.3.2.1q1

N/A

7.3.2.3T7.3.2.3q1a

C

T7.3.2.3q1b

C

T7.3.2.3q1d

C

How does the organization ensure effective communication and clear assignment of responsibility between different groups involved in design and development?

Yes, responsibilities are well defined. Example of part 198911-E, the plan is documented in Q/YCQP4003-04.

The factory does not have design responsibility.

What are the design inputs relating to each of the following product requirements? a) functional and performance requirementsb) applicable statutory and regulatory requirementsc) where applicable, information derived from previous similar designs, andd) other requirements essential for design and development.Where are they recorded?


Design and Development Inputs

Do you use a multidisciplinary approach to prepare for product realization? Does it include:- development/finalization and monitoring of special characteristics- development and review of FMEAs, including actions to reduce potential risks,- development and review of control plans.

NOTE A multidisciplinary approach typically includes the organization's design, manufacturing, engineering, quality, production and other appropriate personnel.

Yes, there is multidisciplinary approach, with mission to develop and finalize special characteristic, record are available

Where are product design input requirements documented? (including the following:- contract reviews of requirements such as special characteristics, identification, traceability and packaging- a process to deploy information gained from previous design projects, competitor analysis, supplier feedback, internal input, field data, and other relevant sources, for current and future projects of a similar nature- targets for product quality, life, reliability, durability, maintainability, timing and cost.)Can you show me they are reviewed?


Product Design Input

How & when are the design inputs reviewed for adequacy?


How does the organization ensure that requirements are complete, unambiguous and don’t conflict with each other?

NOTE: Special characteristics (see 7.2.1.1) are included in this requirement.

Can you show me that all special characteristics are identified and included in drawings, FMEAs, control plans, and operator instructions?

Special characteristics are defined in the form (Q/YCQP4003-08).

Special Characteristics

Do they include process steps that affect special characteristics?

Yes, customer-specified symbols are used in PFD, PFMEA, CONTROL PLAN and work instruction. SEE PHOTOS #29 & #30.

Are the customer-specified (or equivalent) symbols used?

Yes, customer-specified symbols are used in PFD, PFMEA, CONTROL PLAN and work instruction. SEE PHOTOS #29 & #30.

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QUESTIONNAIRES

7.3.37.3.3q1

C

T7.3.3.1q1

N/A

T7.3.3.1q1

C

7.3.47.3.4q1a

C

7.3.4q2

C

7.3.4q3

C

7.3.57.3.5q1

C

7.3.5q2

C

7.3.67.3.6q1

C

7.3.6q3

C

Design and Development OutputsHow can design and development outputs be verified against the inputs? (see 7.3.5q1) Are these outputs approved prior to release?

Outputs of development are verified by dimensional checking, and compared to requirements. Records are maintained.

Can you show that the product design outputs include- design FMEA, reliability results- product special characteristics, specifications- product error-proofing, as appropriate- product definition including drawings or mathematically based data- product design reviews results, and - diagnostic guidelines where applicableAre the outputs expressed in terms that can be verified and validated against product design input requirements?

Not applicable.

Can you show that the manufacturing process design outputs include- specifications and drawings,- manufacturing process flow chart/ layout,- manufacturing process FMEAs,- control plans,- work instructions,- process approval acceptance criteria,- data for quality, reliability, maintainability and measurability- results of error-proofing activities, as appropriate, and - methods of rapid detection and feedback of product/manufacturing process nonconformities.

The manufacturing process design output shall be expressed in terms that can be verified against manufacturing process design input requirements and validated.

Yes, the outputs include all the data, full dimension report (Q/YCQP-4003-13), PFD, PFMEA, Control plan (Q/YCQP-4003-30), Ppk (Q/YCQP-4003-18), etc.

Design and Development ReviewAt what stages of design and development do you perform reviews to evaluate if the results meet requirements? (See 7.3.1q2b)

Can you show me some problems that have been identified and actions proposed at these reviews?

The review is performed to evaluate the progress of the APQP planning. It can be done at each stage.

What functions are represented at these reviews? At each stage, are all functions concerned with that stage represented?

All function are represented.

Can you show me records of the results of the reviews and any necessary actions taken?

SEE PHOTO #39.

What verification activities are performed to ensure that the design and development outputs have met the input requirements? (See 7.3.3q1)

Verification is performed by checking size, functionality and visual appearance and comparing it to requirements in the drawing.

Design and Development Verification

Can you show me records of the results of the verification activities and resulting actions?

SEE PHOTO #40.

Design and Development ValidationWhat design and development validation activities are performed to ensure that the product is capable of meeting the requirements for the intended use?

The validation is done by the client, after sending the PPAP document and sample to them. The client will send a PSW as sign of approval.

Can you show me records of the validation activity results and any follow-up actions?

SEE PHOTO #41.

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C

7.3.77.3.7q1

C

7.3.7q2

C

7.4

7.4.17.4.1q1

C

7.4.1q2

C

7.4.1q3

C

7.4.1q4

C

7.4.1q5

C

T7.4.1.1q1

C

T7.4.1.2q1a

I

T7.4.1.2q1b

C

T7.4.1.2q2

C

PURCHASING

Purchasing Process

Is design and development validation performed in accordance with customer requirements, including program timing?

Yes, the customer will conduct the validation .

How are design and development changes identified? Where are the records kept?

Changes could be identified from internal or from customer, and will be handled according to the procedure (Y/QCDP2010-2011)

Control of Design and Development Changes

Yes, changes are reviewed, verified, validated, and approved before implementation. Records are available.

Are changes reviewed, verified, validated, and approved before implementation?

How do you ensure that purchased product conforms to specified purchase requirements?

The factory has a procedure as guideline for ensuring the conformity of product (Q/YCQP2019-2011).


Can you show me records of the results of supplier evaluations and any necessary actions? Verify that criteria have been met.

How do you determine the type and extent of control applied to the supplier and the purchased product?

The factory has a master list of qualified supplier recorded in the form Q/YCQP-4019-03. SEE PHOTO #42.

How do you evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements?

The factory will conduct investigation of the supplier and record it in the Q/YCQP-4019-05.

Can you show me the criteria for selection, evaluation and re-evaluation of suppliers?

Yes, recorded in the form Q/YCQP-4019-06, conducted in 20XX-01-20 as yearly evaluation approved by General Manager, with hand signed by himself. SEE PHOTO #43.

What evidence is there that all purchased products or materials used in product conform to regulatory requirements?

The factory conduct monthly evaluation of each supplier about QUALITY (40), DELIVERY(20), SERVICE(20) and PRICE(10), and data is recorded automatically in the ERP system in the form Q/YCQP-4019-07.

What supplier development actions are being taken toward the goal of supplier conformity with TS 16949?

Yes, two suppliers have provided commitment to achieve the goal of TS certification by the end of the year 20XX. One out of twenty-one has passed the TS, SEE PHOTO #44.

Do your suppliers’ quality management systems conform with ISO 9001:2000?

NOTE: The prioritization of suppliers for development depends upon, for example, the supplier’s quality performance and the importance of the product supplied.

Yes, 13 suppliers are certified to ISO 9001, and those suppliers are more important.

Are all of your suppliers registered to ISO 9001:2000?If not, do you have written waivers from applicable customer(s)?

Yes, 13 suppliers are certified to ISO 9001, and those suppliers are more important.

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C

7.4.27.4.2q1a

C

7.4.2q1b

C

7.4.2q1c

C

7.4.2q2

C

7.4.37.4.3q1

C

T7.4.3.1q1

C

T7.4.3.2q1

C

7.5

7.5.17.5.1q1a

C

7.5.1q1b

C

7.5.1q1c

C

Purchasing Information

Verification of Purchased Product

Production and Service Provision

Control of Production and Service Provision

Do your customer(s) specify supplier(s) in contracts/ purchase orders? This includes products, materials, services, tooling, & gages, etc.If so, can you show that the customer-designated sources are being used as required?

Yes, all information is included in the plan. The factory has a written program to monitor suppliers.

Do orders/contracts include requirements for approval of product, procedures, processes and equipment?

Yes, reviewed the order number 2014030757 and all information are included.

Do require any qualification of supplier personnel? If so, can you show where the requirement is documented?

Yes, completed.

Do you have any QMS requirements of your suppliers? If so, can you show me where they are required?

Yes, documented.

How does the organization ensure the adequacy of purchasing requirements before communicating them to the supplier?

Communication is done by email, or physically with sign from supplier in the purchase order.

What inspection or other activities are used to ensure that purchased product meets your purchasing requirements?

Incoming inspections are conducted following criteria defined in file (Q/YCQP - 3023-03-2012), SEE PHOTO #45.

What processes are in place to assure the quality of purchased product?

Must include one or more of following:- evaluation of supplier statistical data- receiving inspection and/or testing- second- or third-party audits of suppliers, along with records of acceptable quality- laboratory part evaluation- another method agreed with the customer

Incoming inspections are conducted following criteria defined in file (Q/YCQP - 3023-03-2012). SEE PHOTO #45. And records are maintained in form (Q/YCQP - 4023-03-2012). SEE PHOTO #46.

How do you monitor supplier performance?

Must include the following indicators:- delivered product quality- customer disruptions including field returns- delivery schedule performance (including incidents of premium freight)- special status customer notifications related to quality or delivery issues

The factory conducts monthly evaluation of each supplier about QUALITY (40), DELIVERY(20), SERVICE(20) and PRICE(10). Data is recorded automatically in the ERP system in the form (Q/YCQP-4019-07). SEE PHOTO #47.

When carrying out production (or service) is information that describes the characteristics of the product available?

Yes, information that describes the characteristics of the product available in work Instruction, for example of part 752116400.

When carrying out production (or service) are appropriate work instructions available if needed? (See 7.5.1.2)

Yes. SEE PHOTO #29.

When carrying out production (or service) is suitable equipment used for carrying out production (or service)?

Yes, equipment is available.

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Rev.AUDIT CHECKLIST


QUESTIONNAIRES7.5.1q1d

C

7.5.1q1e

C

7.5.1.1T7.5.1.1q1

C

T7.5.1.1q2

C

T7.5.1.1q3

C

T7.5.1.1q4

C

7.5.1.2T7.5.1.2q1

C

T7.5.1.2q2C

7.5.1.3T7.5.1.3q1

C

T7.5.1.3q2

C

7.5.1.4T7.5.1.4q1

C

Verification of Job Setups

Preventive and Predictive Maintenance

Control Plan

When carrying out production (or service) are appropriate gages, etc. used in production (or service)? (See 7.6)

Yes, gages are available.

When carrying out production (or service) are appropriate kinds of monitoring and measurement done? (See 8.2.4)

Yes, necessary monitoring is conducted, according to in-process inspection.

Can you show me control plans for system, subsystem, and component/ material levels for product supplied?

Review control plans to ensure they:- list controls used for manufacturing process control- include methods for monitoring of control of special characteristics - include customer-required information, if any

Yes, there is control plan developed for each product in which a PPAP is been required. SEE PHOTO #48.

Can you show me control plans for both pre-launch and production?

Yes, there is a control plan developed for each product in which a PPAP has been required. SEE PHOTO #48.

Can you show how the control plans take into consideration design FMEA and process FMEA information?(See Annex A)

Yes, there is control plan developed for each product in which a PPAP is been required. SEE PHOTO #48.

Can you show that specified reaction plans have been carried out when a process becomes unstable or not statistically capable?

SEE PHOTO #48.

Do all employees responsible for processes that impact product quality have documented work instructions? Are they accessible for use at the workstation?

Verify throughout audit. Yes. SEE PHOTOS #29 & #30.Work Instructions

How are the work instructions developed?

SEE PHOTOS #29 & 30.

Can you show me records of job setups that are being performed? Do they occur at the initial run of a job, material changeover, or job change?

Yes, records are written. See photo of U77-1066-MJ-01.

What work instructions do you have for job setup personnel?

Yes. SEE PHOTOS #29 & #30.

How do you identify key process equipment? Can you walk me through your total preventive maintenance system?

Verify that the TPM system includes the following:- planned maintenance activities- packaging and preservation of equipment, tooling and gauging- availability of replacement parts for key manufacturing equipment- documenting, evaluating and improving maintenance objectives

There is a procedure Q/YCQP-2006-2011, B/0 that defined key process equipment in section 3.1 and provided guideline for their maintenance and reparation.

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I

7.5.1.5T7.5.1.5q1

C

T7.5.1.5q2

C

T7.5.1.5q3C

T7.5.1.5q4

I

T7.5.1.5q5

C

T7.5.1.5q6

C

T7.5.1.5q3

C

7.5.1.6T7.5.1.6q1

C

7.5.3

C

C

C

Management of Production Tooling

Identification and Traceability

What resources have the organization provided for tool and gage design, fabrication and verification activities?

The factory has capability for tooling design and production, but will also assigned the design and production responsibility to an external supplier.

There is accumulation time of use in the record CV of each tooling, for example 345844-SHEET2-M1-01, with indication of some per production and its accumulate, but not standard number of time. No reaction of what do to after reach the time.

What predictive maintenance methods do you use? Can you demonstrate that predictive maintenance has resulted in continual improvement of the effectiveness and efficiency of production equipment?

Accident occurrence are recorded in the form Q/YCQP4006-08 and their root cause is investigated in the form Q/YCQP-4006-06 (B/0). See example of machine #YC29. Data collected are not properly used to develop an efficient predictive action.

Does the production tooling management include maintenance and repair facilities and personnel?

There is procedure for Q/YCQP-2007-2011 for the maintenance of mold, fixtures, tooling. Specified in the section 3.1

Do you have space for storage, recovery and set-up of tooling?

Yes, the factory has special place for the storage of tooling.

Do you have perishable tool change programs?

Does tool design modification documentation, including engineering change level, tool modification and revision to documentation monitored?

Yes, controlled by technical department.

Tool identification, defining the status, such as production, repair or disposal.

Tool are well identified and protected. SEE PHOTOS #17 & #49.

Are any tooling management activities outsourced? If so, how are these activities monitored?

Yes, some tolling is outsourced.

Can you demonstrate that customer scheduling requirements (such as just-in-time) are being met?

Yes, the factory uses public board to display the status of each order, with principle of JIT.

Production Scheduling

How do you identify product throughout your processes? Verify in production, storage, segregation areas, etc.

Products are identified as required in the procedure (Q/YCQP2008-2011).

How is product inspection status identified? Verify in production, storage, segregation areas, etc.

Each product has label to indicate its detail and status. SEE PHOTO #50.

Can you show me unique identification records for products requiring traceability?

SEE PHOTO #50.

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QUESTIONNAIRES

7.5.47.5.4q1

N/A

7.5.4q2

C

T7.5.4.1q1

C

7.5.5T7.5.5.1q1

C

T7.5.5.1q2

C

7.67.6q1

C

7.6q2

I

7.6q3a

C

7.6q3c

C

7.6q3e

C

7.6q4

NC

7.6q5

I

7.6q6

I

Customer Property

Preservation of Product, Storage and inventory

Control of Monitoring and Measuring Devices

Do you use any customer-owned property, such as product, packaging, drawings, tooling, gages, etcIf so, ask questions below.

Yes, the factory use customer drawing, tooling as customer property.

How do you ensure that customer-owned property is identified, verified, protected, and safeguarded?

Customer property is controlled as defined in the procedure (Q/YCQP2005-2011).

How do you determine the measurements to be taken and the measuring equipment needed to demonstrate conformity with requirements?

How are customer-owned tools and equipment identified?

Customer-owned tools and equipment identified are identified with customer name and part number.

Can you walk me through your inventory management system?How does the system optimize inventory turns over time and assure stock rotation?

Inventory is conducted via ERP system that can provide in real-time the status of stock, and send information to purchase department.

How is obsolete product controlled to prevent its unintended use or delivery?(See 8.3).

Obsolete product is stored in "red" room to avoid them to be mixed with others.

Measuring devices are controlled according to procedure (Q/YQCP2020-2011).

What process is in place to ensure that measurements are taken per the requirements?

A calibration program is in place to ensure it. The factory is experiencing an Excel support tools to alert in the approach of expiration date, but formulas in this system are wrongly defined.

How do you ensure that measuring and test equipment is calibrated or verified proper frequencies with NIST traceable standards? If no such standards exist, where do you record the basis used for calibration or verification?

External calibration is conducted as planned, and are traceable to external national institute.

How are measuring tools identified to enable the calibration status to be determined?

With tags visible at each device.

How do you ensure that measuring its test equipment is protected from damage and deterioration during handling, maintenance and storage?

Equipment is well protected in the testing center under acceptable room condition. SEE PHOTOS #18, #19, #20, #21, #22 & #23.

When equipment is found to be out of calibration, how do you assess and record the validity of the previous measuring results?

There is no specific plan as reaction plan in the case of out of calibration found, and others damage.

What actions do you take on the equipment and any product affected?

There is no specific plan as reaction plan in the case of out of calibration found, and others damage.

Can I see your records of the results of calibration and verification?

Yes, record of in-house are available by computerized. No signature of the person assigned for the in-house calibration.

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Rev.AUDIT CHECKLIST


QUESTIONNAIRES7.6q7

I

T7.6.1q1

C

T7.6.1q2

C

7.6.2T7.6.2q3

I

T7.6.2q6

C

T7.6.2q7

I

7.6.3T7.6.3.1q1

C

T7.6.3.1q2

I

T7.6.3.2q1

N/A

T7.6.3.2q2

N/A

Calibration / Verification Records.

Where are laboratory technical requirements specified for- adequacy of laboratory procedures- competency of the laboratory personnel- testing of the product,- capability to perform these services correctly, traceable to the relevant process standard, and- review of the related recordsHave these requirements been implemented?

Adequacy of listable procedure with images, and competency of lab people is not visible. Not visible is also the capability to perform services correctly and traceable to respective standard.

Can you show me laboratory scope(s) for external/commercial/independent laboratory facilities that include the capability to perform the required inspection, test or calibration?

Laboratory Requirements

Do you use computer software for monitoring and measurement? If so, is its ability to perform that function confirmed prior to initial use and reconfirmed as necessary?

External calibration is conducted as planned, and are traceable to external national institute, while calibration in house does not provide evidence of such traceability to that external national institute.

Can you show me R&R studies for each type of measuring and test equipment system referenced in the control plan?

Is there other statistical studies analyzing the variation in measurement & test results?

GR&R is conducted for related equipment used to conduct product to which PPAP were required.

Do the methods and acceptance criteria conform to those in customer reference manuals on MSA or does the customer approve them?

Yes, the AIAG format is no longer used.

Can you show that calibration records include equipment identification, including the measurement standard against which the equipment is calibrated.

Calibration record are available both for external. SEE PHOTO #51. Record for in-house calibration is also available, but with no proper traceability of standard used.

Statements of conformity to specification after calibration / verification.

SEE PHOTO #51.

Notification to the customer if suspect product or material has been shipped?

Not planned, but has never happened.

Does the organization have an internal laboratory?If so, can you show a documented laboratory scope including its capability to perform inspection, test, or calibration services?

The factory has testing center, not a laboratory, SEE PHOTO 19, 20, 21, 22, 23.

The lab is for internal use, not external or commercial. There is no scope.

Can I see evidence that each laboratory is either accredited, or is acceptable to the customer(s)?

The lab is for internal use, not external or commercial. There is no scope.

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QUESTIONNAIRES

8

8.1

8.1.1T8.1.1q1

C

8.1.1T8.1.2q1

C

8.2

8.2.18.2.1q1

C

T8.2.1.1q1

C

T8.2.1.1q1

C

8.2.28.2.2q1

C

8.2.2q2

C

8.2.2q3

C

8.2.2q4

C

Monitoring and Measurement

How do you obtain information about customer perception as to whether the organization has met customer requirements? How is this information used?

The organization defined a plan to obtain customer feedback in the (Q/YCQP2024-2011) through customer satisfaction survey. The information is used as input to management review meeting.

Customer Satisfaction

What realization process performance indicators are used to monitor customer satisfaction?

Do they include at least:- delivered part quality performance- customer disruptions including field returns- delivery schedule performance (including incidents of premium freight), and- customer notifications related to quality or delivery issues

Client complaint log and customer satisfaction surveys are used, including internal OTD.

How do you monitor manufacturing processes to demonstrate compliance with customer requirements for product quality and process efficiency?

The manufacturing is monitored with daily rate evaluation and at some process with SPC system.

MEASUREMENT, ANALYSIS AND IMPROVEMENT

General

Reviewed records to demonstrate conformance.

Internal Audit

Knowledge of Basic Statistical Concepts

Are internal audits being conducted at planned intervals? Do they determine whether the QMS conforms to the requirements of ISO 9001 and to the other requirements established by the organization? Do they determine whether the QMS is effectively implemented and maintained?

Can you show me an audit plan that takes into consideration the importance of the processes and areas to be audited, and the results of previous audits?

Yes, there is the audit plan described in Q/YCQP-4022-01 (a/0), nb. 2013001, and approved in 20XX-02-09.

Where are the audit criteria, scope, frequency and methods defined?

Yes, the scope of the audit is described in the Q/YCQP-4022-01 (a/0).

Can you demonstrate that selection of auditors and the conduct of audits are objective and impartial, and that auditors don’t audit their own work?

The factory has 12 auditors. And it requires to avoid auditors to be organized independently to their process.

Have appropriate statistical tools for each process been determined and included in the control plan? (See 7.5.1.1)

Yes, appropriate statistical tools for each process has been determined in the procedure (Q/YCQP2024-2011), where SPC are used at process, and graphical statistic of conformity rate applied to each process and result displayed. SEE PHOTO #15.

Identification of statistical tools

How does the organization ensure that basic statistical concepts are understood and utilized throughout the organization? Verify throughout audit,

Appropriate statistical tools for each process has been determined in the procedure (Q/YCQP2024-2011).

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Rev.AUDIT CHECKLIST


QUESTIONNAIRES8.2.2q5

C

8.2.2q6

C

T8.2.2.1q1

C

T8.2.2.2q1

C

T8.2.2.3q1

C

T8.2.2.4q1

C

T8.2.2.4q2

I

T8.2.2.5q1

C

8.2.38.2.3q1

C

8.2.3q2

C

8.2.3q3

C

T8.2.3.1q1

N/A

T8.2.3.1q2

C

Can you show examples of results of process studies being documented with specifications? Are they used for instructions?

SEE PHOTO #52.

When the desired results are not achieved, what actions are taken to ensure that the product meets requirements?

The result was reviewed during a management review meeting, and actions are defined for improvement.

Can you show me process studies that have been performed on new manufacturing processes?

SEE PHOTO #52.

No, not stated in the procedure.

How do you determine competence of internal auditors to audit the requirements of TS 16949? (See 6.2.2.2 – also customer specific requirements).

Certificate of audit is used as evidence.

Can you show that they have achieved the desired results?

Some processes has KPIs displayed, with acceptable result such as for Supplier Monitoring, while customer satisfaction survey shows some need in improvement.

Yes.

Can you show me an annual audit plan? Does it show that audits cover all QMS processes, activities and shifts?

Yes.

What methods are used to monitor and measure the QMS processes?

The internal audit is used as method to monitor and measure the QMS processes, as required in the procedure (Q/YCQP2022-2011). Apart from that, each process has KPIs assigned with a monitoring plan and responsible.

Monitoring and Measurement of Processes

Is there evidence that audit frequency is increased due to nonconformances or customer complaints?

Who ensures that actions are taken to eliminate detected nonconformities and their causes? Are they being taken care of in a timely manner? (verify with records)

The MR is in charge to ensure that NCF are solved, and recorded maintained, see photo , Report nb. 2013-NA-001 for article TS16949-7.3.6

Do you have records showing that each manufacturing process is being audited to determine its effectiveness?

Yes, each process was audited.

Can you show me your internal audit procedure? Can you show me the records of internal QMS audits?

Do you have audit records showing that the entire QMS is being audited?


Yes, records of internal audit are available, see photo Q/YCQP-4022-08.

Are there records showing that products are being audited at appropriate stages of production and delivery? Do the audits verify conformity to all specified requirements?

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C

T8.2.3.1q5

C

8.2.48.2.4q1

C

8.2.4q2

C

8.2.4q3

C

8.2.4q4

C

8.2.4q5

C

T8.2.4.1q1

C

T8.2.4.2q1

C

8.38.3q1

C

How do you ensure that nonconforming products are identified and controlled to prevent unintended use or delivery? (Verify product throughout audit)

The procedure Q/YCQP2024-2011 is been developed as guideline to control non-conform product

Control of Nonconforming Product

Can you show me layout inspection and functional verification results?Do they address applicable customer specifications and correlate with the control plan requirements?Are results available for customer review?

NOTE: Layout inspection is the complete measurement of all product dimensions shown on the design records.

The layout inspection is documented. SEE PHOTO #45.

Do you provide parts designated by customer(s) as appearance items? If so, what support to you have?

If so can you show that you have:- appropriate resources including lighting for evaluation- masters for color, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), as appropriate- maintenance and control of appearance masters and evaluation equipment, and- verification that personnel making appearance evaluations are competent and qualified to do so

How is evidence of conformity with acceptance criteria maintained?

Record are available. SEE PHOTO #46.

Yes, there are master for comparison, and these master (standard) product are approved by the client and put with proper identification to avoid mixing with others product.

Can you show me records that indicate who has authorized release of product to the next stage of the process?

Record are available, SEE PHOTO #46

How do you ensure that product is not released until the all requirements have been met? If product must be released prior to this, how is it approved?

NOTE: When selecting product parameters to monitor compliance to specified internal and external requirements, the organization determines the types of product characteristics, leading to- the types of measurement- suitable measurement means, and- the capability and skills required

At incoming inspection (IQC), in-process inspection (IPQC) and final inspection (FQC), mainly. Work Instruction for the implementation of such operation are available. SEE PHOTO #45.

At what stages of the product realization process do monitoring and measuring activities take place?

At incoming Inspection (IQC), In-process inspection (IPQC) and final inspection (FQC), mainly. SEE PHOTO #45.

What characteristics are checked to verify that product requirements have been met?

Characteristics to check are clearly documented at various, check plan, for IQC, IPQC and FQC, as required in procedure (Q/YCQP2023-2011).

Monitoring and Measurement of Product

Do records show that manufacturing process capability or original customer-approved performance is being maintained?

Yes, there are record that show that process capability was evaluated and approved by the client, thought PSW, see the case of the client CVSG.

May I have a copy of the process flow diagram and control plan for (mfg. process) to review the production line with? Review for adherence to specified requirements.

The copy of PFD, and Control Plan are available.

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Rev.AUDIT CHECKLIST


QUESTIONNAIRES8.3q2

C

8.3q3

C

8.3q4

C

8.3q5

C

8.3q6

C

8.3.2T8.3.2q1

C

8.3.3T8.3.3q1

I

8.48.4q1

C

C

8.4.1T8.4.1q1

C

How do you compare trends in quality and operational performance with progress toward objectives?Does the comparison lead to action to supporting the following?- development of priorities for prompt solutions to customer-related problems- determination of key customer-related trends and correlation for status review decision-making and longer term planning- an information system for the timely reporting of product information arising from usage.

Data is used to compare trends in monthly / annual basis and to display opportunities from improvements. Decisions are taken during management review meetings.

What data is collected and analyzed to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of its effectiveness can be made?

Internal / external PPM, OTD record, supplier performance evaluation, NCF from internal audit, amounts others KPIs assigned, and customer satisfaction are collected.

What information does this analysis provide relating to:- customer satisfaction (See 5.6) - conformity to product requirements (See 5.6)- characteristics and trends of processes and products (See 5.6)- suppliers (See 7.4.1)

Internal / external PPM, OTD record, supplier performance evaluation, NCF from internal audit, amounts others KPIs assigned, and customer satisfaction are collected.

Analysis of Data

Do you have evidence that customers are promptly notified if nonconforming product is shipped?

No evidence saved.

Can you show me instructions for rework? Do they include re-inspection requirements? Are they accessible and utilized?

Yes, there is special place for the reworking, specially for welding reworking.

Customer Information

When nonconforming product is detected after shipment, what actions are taken, such as containment? (Verify corrective action records)

Yes, actions are defined as to inform the client.

Can you show me records of nonconforming product and any actions taken? Are there any records of concessions obtained?

Records are available, product is stored with label at segregate area. SEE PHOTOS #53 & #54.

When nonconforming product is corrected, can you demonstrate that it is re-verified to ensure it conforms to requirements?


Can you show me your documented procedure defining the controls for dealing with nonconforming product?Does it include related responsibilities and authorities?

The procedure Q/YCQP2024-2011 is available and defines responsibilities.

When you have nonconforming product, what methods do you use to deal with it?

a) by taking action to eliminate the detected nonconformityb) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customerc) by taking action to preclude its original intended use or application.

Control of Reworked Product

Analysis and Use of Data

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QUESTIONNAIRES

8.5

8.5.18.5.1q1

C

T8.5.1.1q1

C

T8.5.1.2q1

C

8.5.28.5.2q1

C

8.5.2q2C

8.5.2q3

C

8.5.2q4

C

T8.5.2.1q1

C

T8.5.2.1q2

C

T8.5.2.2q1

C

8.5.2.4T8.5.2.4q1a

C

T8.5.2.4q1b

C

T8.5.2.4q1c

C

Is the time consistent with the determination of root cause, corrective action and monitoring the effectiveness of implementation?

Yes, the time is sufficient.

Can you show me records of analysis of parts rejected by customer manufacturing plants, engineering facilities and dealerships?

Yes, an 8D report is used to identify root cause of problem. For example, the case #130060 on the part number 204327.

How long does the analysis take?Are records made available (to customers) upon request?

The lead time has been defined as couple of weeks in the procedure (Q/YCQP2026-2011).

Can you show that error-proofing methods are used in the corrective action process?

Yes. SEE PHOTO #31.

Where is the process for problem solving defined?Does it lead to root cause identification and elimination? (Review records)

Yes, the procedure (Q/YCQP2026-2011)

If one or more customer requires a specific problem-solving format can you show me records documented as required?

Yes, and 8D report is used to identify root cause of problem. For example, the case #130060 on the part number 204327.

Can you show me a documented procedure defining requirements?

a) Reviewing nonconformities (including customer complaints)b) Determining the causes of nonconformitiesc) Evaluating the need for action to ensure that nonconformities do not recurd) Determining and implementing action needede) Records of the results of action takenf) Reviewing corrective action taken

Yes, the procedure (Q/YCQP2026-2011).

Can you show me records of corrective actions taken?

Yes, and 8D report is used to identify root cause of problem, for example of the case #130060 on the part number 204327.

Do corrective actions records identify and address root cause(s)? Do root causes match actions?

Yes. Verified.

Are actions taken appropriate to the severity of the problem?

Yes, for example of the case #130060 on the part number 204327.

The process for continual improvement is defined in the procedure (Q/YCQP2026-2011).

Can you show that CI efforts focus on control and reduction of variation in product and process characteristics after capability, stability, and conformity?

Yes, there are records of continual improvement. SEE PHOTO #31.

Corrective Action

Rejected Product Test/Analysis

Can you demonstrate that Organization’s QMS effectiveness continually improves? What tools do you use? (See 5.6, 8.2.2, 8.4, 8.5.2, 8.5.3)

The internal audit is used a basic tool to demonstrate that the organization's QMS run effectively.

Where has Organization defined a process for continual improvement?

Improvement

Continual Improvement

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QUESTIONNAIRES

8.5.38.5.3q1

C

8.5.3q2

C

8.5.3q3

C

Are actions taken appropriate to the severity of the problem?

Yes, actions are taken in consideration of the value RPN obtained from the Severity (S), Occurrence (O) and Current Detection Method (D).

Can you show me a documented procedure defining requirements for each of the following? a) determining potential nonconformities and their causesb) evaluating the need for action to prevent occurrence of nonconformities,c) determining and implementing action neededd) records of results of action taken (see 4.2.4), ande) reviewing preventive action taken

Yes, the procedure is Q/YCQP2026-2011.

How do you determine potential nonconformities to take action one? Do preventive action records identify and address root cause(s)?

PFMEA is used as mean tool to determine potential nonconformities, and proposal action are recorded.

Preventive Action

0

Supplier Name Audit Date Report No.

ISO / TS 16949 QMS Audit Form Rev.FACTORY PHOTOS

XXXXXXXXXXXXXXX XX/XX/XXXX XXXXXXXXX

1. Factory's main gate 2. Process map

3.Subsequence between processes 4. Organization

5. Stamping workshop 6. Stamping process & layout

0




9. Company policy posted at a public board 10. Master list of quality procedures

7. Policy & Quality Objectives 8. Distribution of KPIs

11. Master list of quality records 12. Evidence of identification of file under control

0




16. Status of KPI as input for management Review

17. Storage of tooling 18. Meaurement device CMM

15. Status of KPIs published at workshop

13. Nomination letter of management representative 14. List of identified customer special requirement

0




24. Training program

20. Function test

21. Project profile 22. Hardness test

19. Salt spray test device

23. UV machine

0




25. Training program for special job position 26. Traing test record

27. Training record 28 Document

29. Work instruction at assembly line 30. Work instruction at assembly line

0




33. A view of client's product 34. A view of packaging process for client's product

35. A view of layout at workshop 36. APQP file

31. Record of continual improvement. 32. A view of assembly line

0




40. Record of status of pahse 4th of APQP 41. PSW signed by the client for approve

42. List of qualified suppliers 43. Record of supplier evaluation

37. List of special characteristic 39. Record of review at the 1st phase of APQP

0




46. Record of IPQC 47. Record of annual performance of supplier

48. Control plan 49. Indication of tooling status

44. Suppliers certification program 45. Inspection criteria for IQC

0




52. Record of client feedback about quality 53. Non-conforming storage and identification

50 A view of material handling and identification 51. A view of Inspection device & calibration certificate.