ISO/TS Audit Report. * Example Report *

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1 ISO/TS Audit Report * Example Report * North America Latin America Europe & Middle-East Asia & Asia Pacific info@proqc.com

2 ISO/TS Quality Management System Audit GUIDELINES PURPOSE: This audit checklist was created based on requirements defined in the following standards: - ISO/TS standard - AIAG 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. SORING: Scores are assigned based on what is done for the Pro Q client regardless of what is done for other clients. For example, if control plans are developed for other clients but not for the Pro Q client, the score must be N. Scoring must be explained to the supplier at the opening meeting. omplies with the Requirements = Improvement Needed = I Non-onformance Found = N N/A = Does Not Apply GUIDELINE FOR SORING ONFORMANE: 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. omplies with Requirements = - Has objective evidence to support the question, and - Has a written procedure (when required). 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. Non-onformance = - No objective evidence to support the question (regardless of the procedure). - Lacking some objective evidence and no written procedure. RESULTS/REOMMENDATIONS: (Automatically alculated) The score is based on the percent of questions that omplies with Requirements, percent that Needs Improvement, and the percent that have a Non-onformance. 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: 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. ORRETIVE ATIONS: 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.

3 Supplier Name ISO / TS QMS Audit Form SUMMARY Audit Date Report No. NAME : NAME : XX ADDRESS : ADDRESS : XX ITY : ITY : XX OUNTRY: SUPPLIER'S INFORMATION OUNTRY: XX Mr./Mrs. Title: XXX Mr./Mrs. Title: XXX Mr./Mrs. Title: XXX Mr./Mrs. Title: XXX Mr./Mrs. Title: LIENT'S INFORMATION XX PHONE : PHONE : XX FAX : FAX : XX SUPPLIER'S PERSONNEL PARTIIPATING XXXXX XXXXX XXXXX XXXXX Pro Q Personnel Mr./Mrs. XXXXX Title: X Mr./Mrs. XXXXX Title: X X X AUDIT RESULTS = 92.93% 4. QUALITY ategory 8 MEASUREMENT, ANALYSIS ADUT REALIZURE MANAMENT RESP MANAGEM 4. QUALITY MANAGEMENT SYSTEM ENT omplies ( ) 96.5% 91.67% 88.46% 91.89% 96.77% Needed Improvement ( I ) Not-complies (N) Not Applicable (N/A) 5. MANAGEMENT RESPONSIBILITY 6. RESOURE MANAGEMENT 3.5% 7.58% 11.54% 8.11% 3.23%.%.76%.%.%.% 1.8% 12.12%.%.%.% 7. PRODUT REALIZATION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT % 1% 2% 3% 4% 5% 6% 7% 8% 9% 1% omplies)()))) Needed)Improvement)()I))) Not3complies)(N)) REOMMENDATIONS The system is well documented and implemented effectively. You could start or continue business with this supplier. The system is acceptable, with minor nonconformities noted. You could use this supplier and keep pushing them for improvement. System has several major issues noted. You could temporarily use this supplier and request immediate corrective action in case of long-term business. There are serious majors issues noted with this supplier that could impact your business. This supplier will need significant time and resources to be compliant to requirements. The best solution will be to source another supplier.

4 Supplier Name ISO/TS QMS Audit AUDIT REPORT Audit Date Report No. Scope of Audit: To evaluate the Quality Management System of the supplier. Summary / Recommendations: The audited factory is located in XXXXXX. The factory has approximately 5 to 6 people working full-time. There are two various productions, with one already certified to ISO/TS 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 to requirement of TS, with staff well trained in the maintenance of QMS. The factory has experience working with 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 overcome few improvements listed here below in order to further reduce quality risk. Strengths: 1. The factory is TS certified, with the system controlled by well qualified people / auditors (12). 2. The people in charge of QM has clear understanding of PDA 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. Excellent supplier management / control, with one supplier TS certified, two committed to complete within a couple of months, 13 out of 21 ISO 91 certified. Opportunities for Improvement: 1. Quality objectives: KPIs should be updated and published on a monthly basis at various workshops. 2. ompetence of people: Skill matrix should be defined and published at testing center. 3. Human resources: Must have a replacement staff, when key people are not available. 4. Management review input: Use PFMEA as input during management review meeting. 5. Predictive maintenance: Tool life circle time to be defined in the tooling V. 6. ontrol of changes: Must specify a list documents that could be affected by specific changes. 7. alibration: Should have a calibration program with an alert sign when approaching the expiration date. 8. alibration: Internal calibration to be traceable to external source. 9. Recording: In-house calibration to be recorded by hand, not in the computer. 1. alibration: Employees must have a plan when an equipment is found out of calibration or damaged. 11. Testing method: ould provide specific work instruction for some testing devices with images. 12. TS ertification: 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.

5 AUDIT HEKLIST = omplies with the requirements, I = Improvement Needed, N = Not omplies, N/A = Not Applicable EVIDENE TO HEK QUALITY MANAGEMENT SYSTEM General Requirements Has the organization established, Evidences of this question can be demonstrated Yes, the organization has established, documented, implemented and throughout the audit. documented, implemented and maintains a maintained a QMS and continually QMS according to ISO / TS requirements 4.1q1 improved its effectiveness in accordance (Exclude 7.3), and has evidences of with ISO/TS 16949:29? continually improving its effectiveness. SORE 4.1q2a Has the organization identified the processes needed for the QMS and their application throughout the organization? [ISO/TS 16949:29, Art 4.2.2] Yes, the organization identified the processes needed for the QMS, in their Quality Manual (Q/YQP11-211, page 14/36), and their application throughout the organization. SEE PHOTO #2. 4.1q2b Has organization determined the sequence and interaction of QMS processes? [ISO/TS 16949:29, Art 4.2.2] Yes, the organization determined the sequence and interaction of processes in the Quality Manual (Q/YQP11-211, page 15/36). SEE PHOTO #3. 4.1q2c 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 PDA to monitor performance of processes for effectiveness. Each process has procedures and guidelines and with defined KPIs. 4.1q2d Has the organization provided resources and information needed to support the operation and monitoring of QMS processes? (See Section 6) Yes, resources are provided, with qualified operators under an organization chart and with adequate two facilities, with necessary equipments. SEE PHOTOS #4, #5 & #6. 4.1q2e 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 2XX, and planning for the year 2XX. SEE PHOTOS #7 AND #8. 4.1q2f Does the Organization implemented actions necessary to achieve planned results and continual improvement of processes needed for the QMS? Yes, the Organization has evidences of implementation of continual improvement thought effective management review Are processes needed for the QMS Yes, processes are managed with KPIs. 4.1q3 managed by the organization in SEE PHOTOS #7 and 8. accordance with the requirements of ISO/TS 16949:29? When the organization outsources any The organization purchases few process that affects product conformity components from others suppliers, and gets with requirements, how is control support from external service for calibration ensured over such processes? (See 7.4) of equipment. All of these external 4.1q4 outsources are managed according to the requirements of the Purchase Procedure (Q/YQP ). Where is the control of outsourced processes that affect product conformity 4.1q5 with requirements identified within the QMS? (See 7.4) It is identified in the purchase.

6 AUDIT HEKLIST T4.1.1q q1a = omplies with the requirements, I = Improvement Needed, N = Not omplies, N/A = Not Applicable Does the organization have adequate control over outsourced processes to ensure conformity to all customer requirements? (See 7.4) Does the organization have documented statements of a quality policy (QP) and quality objectives (QO)? ISO/TS 16949:29, Art 5.3, EVIDENE TO HEK Documentation Requirements a) Review where it's written and note the doc, if any. b) heck if the QP/QO posted in a visible place for all employee to view. c) Take a photo. Yes, incoming inspections are conducted per random sampling. Suppliers are selected per requirement, and are evaluated on an annual basis. Yes, the Quality Policy is documented in the Quality Manual (Q/YQP11-211, rev ), published and signed by GM. SEE PHOTO #9. Quality objectives are also listed, with a distribution to each department. SEE PHOTO #7. SORE 4.2.1q1b Does Organization have a quality manual? ISO/TS 16949:29, Art 4.2.1(b) Review the Quality Manual, and note the doc. and rev. Yes, the factory has a Quality Manual 2XX (Q/YQP11-211, rev ) published in q1c Does the organization have the documented procedures required by ISO 91:28? ISO/TS 16949:29, 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 # q1d 4.2.1q1e Are adequate documents in place to ensure the effective planning, operation and control of t organization s processes? ISO/TS 16949:29, Art 4.2.1(d) Does documentation include the records required by ISO 91:28? ISO/TS 16949:29, Art 4.2.1(e) Evidences of this question could be demonstrated throughout the audit. a) Review the master list for record and confirm that all records monitored are included. b) Take photo of the master list. Yes, documentation is visible at each place as guideline. Yes, the factory has procedure for the control of record (Q/YQP , B/.) There is a master list of ten pages describing all Quality Record to save, including saving place, and time. SEE PHOTO # q1a If any, is the scope of the quality management system identified in the QMS, including details of and justification for exclusions? ISO/TS 16949:29, Art 4.2.2(a) Quality Manual 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 1/36, where it declared to exclude 7.3, , q1b Does the quality manual (QM) contain or reference the documented procedures established for the QMS? ISO/TS 16949:29, Art 4.2.2(b) heck 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 q1c Does the quality manual include a description of the interaction between the processes of the QMS? ISO/TS 16949:29, Art 4.2.2(c) a) heck 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. Yes, there is process map described in the QM page 14/36, with five ustomer related processes (1, 2, 3, 4), supporting processes, and management processes, including their relation in page 15/36 of the QM. SEE PHOTOS #2 & # q1 Are the documents required by the QMS controlled? ISO/TS 16949:29, Art ontrol of Documents a) Ask if there is a master list containing all Yes, there is procedure for the control of documents for QMS, with doc title, current document (Q/YQP ). hecked revision and distribution record / name of users. mold maintenance document (Q/YQPb) Select few docs from the master list, and XX) distributed in 2XX-3-13, cross check on site (user hands) if these docs and has signature of related department. have same doc. nb, rev. nb, and accurate nb of Record are written in form (Q/YQP-412- copy distributed. 2, A/).

7 AUDIT HEKLIST 4.2.3q2a = omplies with the requirements, I = Improvement Needed, N = Not omplies, N/A = Not Applicable Is there a documented procedure that defines the controls needed for approve INTERNAL documents for adequacy prior to issue? ISO/TS 16949:29, Art EVIDENE TO HEK a) Ask for the procedure of document control, Yes, it described in the procedure (Q/YQPand note its doc. nb and current revision in the ), step 6.2. The authority report. regarding document review and approval is b) heck if this procedure contain clear defined in the procedure (Q/YQP-212- requirements need for: -211, B/) page 6/6. Ensuring the legibility and identification - Authorities for approve prior to issue - Ensure that only latest rev. at workplace - Ensure the identification of changes SORE 4.2.3q2f 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 16949:29, Art a) Ask if there is a masterlist containing all Yes, the is requirements for the control of documents for QMS, with doc title, doc. Nb. external documents (Q/YQP , urrent revision. And distribution record / name step 6.8). There is a masterlist of external of users. document written in form (Q/YQP-412- b) Select few docs from the masterlist, and 7, a/1). An obsolete stamp is putted in the cross check on site (User hands) if these docs drawing for identification. SEE PHOTO #12 have same doc. nb, rev. Nb, and accurate nb of of drawing Nb. SA1456-D as example. copy distributed q2g 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 16949:29, Art a) Ask the responsible to explain how to prevent Yes, there are requirements for the control the use of obsolete documents. b) heck of external documents (Q/YQP-212- if there is a documented procedure for: 211, step 6.8). There is a master list of - Identification of obsolete doc. external documents written in form - Retention period and location c) (Q/YQP-412-7, a/1). An obsolete stamp Note the doc nb. and current rev. in this report. is putted in the drawing for identification. SEE PHOTO #12. Is there any evidences of how to easily identify obsolete documents to prevent them for unintended use? ISO/TS 16949:29, Art a) heck if there is visible "UNDER ONTROL" 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. Yes, document has OBSOLETE stamp putted in the drawing, SEE PHOTO #12 of drawing Nb. SA1456-D as example T q1 Does 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 16949:29, Art Engineering Specifications a) heck if this process is included in any Yes, the company has a process (SP1) with document, note its doc. nb and rev. detail described in the procedure b) heck if FMEA, ontrol Plans etc are (Q/YQP , section 6.8) for update included as potential document to review as per and timely distribution of updated customer customer-required schedule(s). specification and changes. It does not have clarification of what others documents could be affected by specific changes. I T q2 Does the review occur in two weeks or less? ISO/TS 16949:29, Art heck if the company includes time spent to implement. Yes, the requirement to complete the review and distribution is been defined for two weeks in the (Q/YQP , section 6.8.2) T q3 What records do you have showing implementation dates of changes? Is there evidence showing that documents are updated? ISO/TS 16949:29, Art a) heck if the company maintains a record of Yes, records are available. 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, ontrol Plans...etc).

8 AUDIT HEKLIST q1 = omplies with the requirements, I = Improvement Needed, N = Not omplies, N/A = Not Applicable 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 16949:29, Art EVIDENE TO HEK ontrol of Records a) heck if the company has a masterlist that with all quality records with detail of: - Name / template nb. - reation 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. SORE 4.2.4q2 Are records legible, readily identifiable and retrievable? ISO/TS 16949:29, Art Should be reviewed throughout the audit. Yes, records are available 4.2.4q3 Does Organization have a documented procedure defining the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records? ISO/TS 16949:29, Art Review the procedure and note its doc. nb and current revision. Yes, the procedure (Q/YQP ) provide guidelines for the control of records listed in the masterlist. T q1 Have the record requirements been reviewed to ensure conformance with regulatory and customer requirements? ISO/TS 16949:29, Art Should be reviewed throughout the audit. Yes, records are to be review by a Review few records at every process to see if supervisor, with signature as conformity. there is signature / name of the operator and for the reviewer and approver. 5 MANAGEMENT RESPONSIBILITY q1a Does top management communicate the importance of meeting customer and statutory and regulatory requirements to the organization? Management ommitment a) Review records (with attendance) of meeting Yes, the communication of customer will be held by top management. b) communicated to members following the Review records of meeting related to any new APQP process, to be checked during project. product/ process realization, with record attached. 5.1q1b Has a company quality policy (QP) been established? (See 5.3) a) heck if there QP documented, hand signed by top management. b) heck 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/YQP11-211, rev ), published and signed by GM. SEE PHOTO #9. 5.1q1c Has company established quality objectives and communicated all members? (See 5.4.1) a) heck 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. 5.1q1d Does top management conduct management reviews? (See 5.6) a) heck if there a documented as guideline to conduct management reviews, and note the doc. nb / rev. b) Review record of last two management reviews. Yes, the factory has a procedure for management review (Q/YQP , B/). The last management review was conducted in 2XX There is a form for plan. (Q/HLQP-416-1) 5.1q1e 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. I T5.1.1q1 Does top management review product realization and support processes to ensure effectiveness and efficiency? (5.6?) Yes, the factory uses a multi-functional team, with a delegate to supervise the process. Records are available.

9 AUDIT HEKLIST q1 = omplies with the requirements, I = Improvement Needed, N = Not omplies, N/A = Not Applicable Has top management ensured that customer requirements are determined and met with the aim of enhancing customer satisfaction? EVIDENE TO HEK ustomer Focus a) heck if there is any responsible person or group dedicated for identification of customer requirements. b) heck if there any records showing a list of identified requirements per customer, and related procedures or method applied to fit them. Yes, the company has nominated a responsible party to act as ustomer Rep. with responsibility to ensure that customer requirements are determined. SEE PHOTO #13. (Q/YQP11-211, page 5/36). The factory also maintains a record describing all customer requirement records. (Q/YQP ) SEE PHOTO #14. SORE q1a Does top management ensure that the quality policy is appropriate to the purpose of the organization? Read the quality policy. Quality Policy Yes, the quality policy is well appropriate, and applicable to their facility. 5.3q1b 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. 5.3q1c 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 2XX. There is plan of how these KPIs are monitored. SEE PHOTO #8. 5.3q1d Is the quality policy communicated and understood within the organization? a) heck if there is QP documented and hand signed by top management. b) heck if QP is posted in public board for all employees to view. Yes, the Quality Policy is documented in the Quality Manual (Q/YQP11-211, rev ), published and signed by GM, posted in published place visible by all. SEE PHOTO #9. 5.3q1e Is there an established process to review the quality policy for continuing suitability? Yes, from management review meeting. 5.4 Planning q q2 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? Quality Objectives heck if the quality objectives are hand signed by all managers and published. 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) heck if the result are published and take a photo of quality objectives. Yes, quality objectives are also listed, with a distribution to each department. SEE PHOTO #7. Yes, the quality objectives are consistent with the quality policy. SEE PHOTO #8. T q1 Are quality objectives and metrics included in the business plan? heck if the quality objectives are hand signed by all managers and published. Yes, it is included. SEE PHOTO # q1a Does the company ensure that the planning of the QMS is carried out in order to meet the requirements given in ISO /TS 16949:29 section 4.1, as well as the quality objectives? Quality Management System Planning 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.

10 AUDIT HEKLIST 5.4.2q1b = omplies with the requirements, I = Improvement Needed, N = Not omplies, N/A = Not Applicable How do you ensure that the integrity of the QMS is maintained when changes to the QMS are planned and implemented? EVIDENE TO HEK a) heck if there is a document as guideline to handle any changes that could potentially happen, note doc. nb / rev. b) heck if the company has a reaction plan with responsible for implementing changes. Yes, following the procedure (Q/YQP21-211), with responsibility under Manager of Technical Department. SORE 5.5 Responsibility, Authority and ommunication q1 Are responsibilities and authorities defined and communicated within the organization? (Verify throughout audit) Responsibility and Authority a) heck the organization chart and take photo. b) heck if there is detailed job description for every position within the organization. c) heck if there is a planning for replacement in the absence of key person, and related training record / qualifications. Yes, there is an Organization hart in the Quality Manual (Q/YQP11-211, 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 enter. I T q1 Are managers responsible for corrective action informed of nonconforming products or processes? Are they informed in a timely manner? a) heck if there a document that describes the flow for the communication of quality issues, and note the doc. nb / rev. b) heck if a record of internal / external complaints are maintained. Yes, it is implemented accordingly and records are available. T q2 Do personnel responsible for product quality have the authority to stop production to correct quality problems? Review JD for Quality Manager / Supervisor and check if this is included. Yes, it is defined in the JD of the Quality Department, No. 9. T q3 What personnel on each shift have responsibility for ensuring product quality? heck if there is a representative of the Quality Department in charge of quality for the whole company. Note his/her name. Yes, each facility under this organization has responsibility of quality to ensure the quality of product q1 Is there a ISO/TS Management Representative (MR)? Management Representative heck if there is nomination letter and take photo. Yes, it documented in the QM, page 4/36. Mr. XXX is nominated as Management Representative q1a 5.5.2q1b Does the MR have responsibility and authority to ensure that processes needed for the QMS are established, implemented and maintained? Does the MR have the responsibility to report to top management on the performance of the QMS and any need for improvement? Review JD for MR and check if this is included. 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?) Yes, it is included. Yes, it is included q1c T q1 Does the MR have the responsibility to ensure the promotion of awareness of customer requirements throughout the organization? Has top management designated as ustomer Representative to ensure that customer requirements are addressed? Review JD for MR, and check if this is included. Yes, it is included. heck if there is nomination letter, take photo of that letter. Yes, it is defined in the QM, page 5/36. c T q2 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.

11 AUDIT HEKLIST q1 = omplies with the requirements, I = Improvement Needed, N = Not omplies, N/A = Not Applicable How is information regarding the effectiveness of the QMS communicated within the organization? EVIDENE TO HEK Internal ommunication a) heck if the company has defined clear The method of communication is defined in methods ( , fax, telephone, meeting, paper related procedure, and change depending record) for communication of information. to the type of information. , ERP b) heck if the implementation of these are system mainly is used, including public effective and their efficiency monitored (On time board, to inform about performance. SEE delivery, accuracy). PHOTO #15. SORE q1 What is the frequency that top management reviews the organization's QMS? Management Review heck if it documented to conduct management It is written in the procedure that the review at least one time per year and in specific management review will be conducted one circumstances. Note the doc. nb / rev. time per year q2 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) heck 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 2XX-12-21, following are reviewed written in Q/YQP (a/): - Policy and objective - Last internal audit record - Improvement opportunity 5.6.1q3 an you show me records from recent management reviews? heck records of last two management reviews and compare status of improvement between both. Yes, reviewed the record of last management review conducted in 2XX T q1 Do management reviews include all requirements of the quality management system and performance trends? (Verify records) Verify records of last two management reviews. Record of review are checked for the year 2XX. Performance trends of the year 2XX recorded in document ( Q/YQP-416-5, B/). T q2 an 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. Yes, recorded in the form Q/YQP-416-5, B/) T q q1 an you show records providing evidence of achievement of the quality objectives specified in the business plan, and customer satisfaction with product supplied? an you show me that each of the following were included in review(s)? a) results of audits, b) customer feedback c) process performance and product conformity d) status of preventive and corrective actions e) follow-up actions from previous management reviews f) changes that could affect the quality management system, and g) recommendations for improvement Verify records performance of each objectives and take photo. Review input Record are available. SEE PHOTO #16. a) Verify if there is document specifying the type Yes, all inputs are included in the file of input for the management review and note Q/YQP (a/). the doc. nb/ rev. b) Verify if all mandatory inputs are listed, and include evidences for the last two management review meeting. T q1 Do records show input to management review includes analysis of actual and potential field-failures and their impact? (See also ) Did not include PFMEA as input to management review. I q1 What 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 processes b) improvement of product related to customer requirements, and c) resource needs Review Output 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. Yes, decision of output are listed in the form Q/YQP (a/).

12 AUDIT HEKLIST q1a = omplies with the requirements, I = Improvement Needed, N = Not omplies, N/A = Not Applicable What resources has the organization provided to implement and maintain the QMS and continually improve its effectiveness? EVIDENE TO HEK RESOURE MANAGEMENT Review factory profile. Provision of Resources The factory provided manpower resource for the QMS, and ERP system for internal communication, etc. SORE 6.1q1b 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 ENTER - SEE PHOTOS #18, #19, #2, #21, # Human Resources - General q1 What are the education, training, skills and experience required by this job/task? How does this person meet those qualifications? General a) Verify of the factory has skill matrix defined for key personnel. b) While auditing, select some personnel performing work affecting product quality. The factory has defined skill matrix for each level of employee, documented in the file (Q/YQP ). SEE PHOTO # q1a How do you determine the necessary education, training, skills and experience for people performing work affecting product quality? ompetence, Awareness and Training Verify if the factory has system for identification of training need. The factory has procedure (Q/YQP ) for guideline for the identification of training. Training are for new hiring people and for annual training q1b What training or other actions do you provide to satisfy the needs of personnel? 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/YQP ) for the year 2XX, and approved by the leader in 2XX-1-7. SEE PHOTO # q1c When you provide training or other actions to satisfy competence needs, how do you evaluate the effectiveness of those actions? (records) 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. The method of evaluation is defined in the file (Q/YQP ). SEE PHOTO # q1e Where do you maintain records of education, training, skills and experience? 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. T q1 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. The factory has identified specific design software such as PRO / E, Autocad and solid work. T q2 What records do you have showing that product design personnel are competent to design and are skilled in the identified tools and techniques? Verify design personal skill matrix and related certificate / training record. Training of technical people has been planned in the document (Q/YQP ) 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. I T q1 an you show me documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting product quality? heck the existence of the procedure, and note doc. nb / rev. Yes, the record of training are available in the document (Q/YQP-417).

13 AUDIT HEKLIST T q2 = omplies with the requirements, I = Improvement Needed, N = Not omplies, N/A = Not Applicable What records do you have that personnel performing specific assigned tasks are qualified - especially to meet customer requirements? (See 6.2.2e) EVIDENE TO HEK 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/YQP ) 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. SORE I T q1 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. Record of training are available. ontract and agency are not used in this factory. T q2 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. By meeting, and posting of process files on site as work instruction and red sign on specify product/process characteristic. SEE PHOTOS # 29 & #3. T q1 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) Any promotion activities? b) Employee satisfaction survey and record? c) Are KPIs published at each workplace for employee to review? 1. Salary increase of 1% to 15% 2. KPIs are published on site. 3. Employee satisfactory survey (Q/YQP 421-5) conducted in 2XX-11-2, and summarized in Q/YQP T q2 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? Yes, a promotion is planned to enforce quality and technological awareness throughout the whole organization. SEE PHOTO #31. T q3 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) 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 # q1a Are the buildings, workspace and utilities provided appropriate to achieve conformity to product requirements? How are they maintained? Infrastructure a) Visit the facility, specially the condition of how Yes. SEE PHOTO #5, #6 & #17. product / material are stored. b) Verify if the factory has a maintenance program. 6.3q1b 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. 6.3q1c T6.3.1q1 What supporting services (such as transport or communication) are needed to ensure that product meets requirements? How are they maintained? What groups are involved in developing plant, facility and equipment plans? (Must be multidisciplinary) Listed in the factory profile and take photos. Plant, Facility and Equipment Planning Verify if there is map route describing position of machine, storage of material, moving of people. 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.

14 AUDIT HEKLIST T6.3.1q2 = omplies with the requirements, I = Improvement Needed, N = Not omplies, N/A = Not Applicable an you show that plant layouts optimize material travel, handling and floor space use, and facilitate synchronous material flow? EVIDENE TO HEK a) Is the pathways visible defined for material storage, machines position and peoples rotation? Take photo. b) Is the direction of moving clearly marked? Yes, the plant layouts optimize material travel, handling and floor space use, and facilitate synchronous material flow. SEE PHOTOS #5 & #6. SORE T6.3.1q3 What methods are used to evaluate and monitor the effectiveness of existing operations? 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 T6.3.2q1 an you show contingency plans for each of the following? - Utility interruptions - Labor shortages - Key equipment failure(s) - Field returns ontingency Plans a) Verify if there is a documented plan to handle Yes, there is contingency plan for labor sudden short down in the planning, take photo shortage, key equipments failure etc. of the plan. b) Ask if such situation happen, and what was the impact. c) Does the contingency plan describe responsibility? q1 Has the organization defined the adequate work environment required to achieve conformity to product requirements? How is this environment managed and maintained? Work Environment 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/YQP ) T6.4.1q1 How are product safety and potential risks to employees addressed by the organization? Each machine has user manual visible. ould better be written with images that indicate what to do when using it, both at workshop and testing center. I T6.4.2q1 Does the organization maintain the state of order, cleanliness and repair needed for products and manufacturing processes? (Verify throughout audit) Yes, it is clean and well organized at the stamping plant and assembly plant. 7 PRODUT REALIZATION q1 Are the processes needed for product realization identified? Planning of Product Realization Verify if there a process map or flow chart for product realization and note doc nb / rev. Yes, the guidelines are described in the procedure (Q/YQP24-211), under responsibility of production department. 7.1q2 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. heck 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. 7.1q3a 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) heck if there a record as example of any product. Yes, it planned, as for example of the development of product / project # E. SEE PHOTO #36. The identification is planned with the output recorded in the form (Q/YQP ). 7.1q3b 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) heck if there a record as example of any product. The planning of production realization is documented as project planning such as for the case of project # E. SEE PHOTO #36.

15 AUDIT HEKLIST 7.1q3c = omplies with the requirements, I = Improvement Needed, N = Not omplies, N/A = Not Applicable EVIDENE TO HEK How do you determine verification, a) Verify if there is planning defining method for validation, monitoring, inspection and verification, validation etc. test activities specific to the product, and b) heck if there a record as example of any the criteria for product acceptance? product. The stage of verification, validation and monitoring of production realization are documented as project planning such as for the case of project # E. SEE PHOTO #36. SORE 7.1q3d What records exist showing that both the realization processes and the product meet requirements? heck if there a record as example of any product. Records of the four stages are available, example of the project # E. 7.1q4 What are the outputs of product realization planning? Are they in a form suitable for the organization? Verify if there a documented planning. Yes, forms are used to record output of the product realization T7.1.1q1 Does the quality plan include customer requirements and reference to technical specifications? Planning of Product Realization Supplemental Review the quality plan Yes, it included, example of the project # E T7.1.2q1 Where are acceptance criteria defined? When required, does the customer approve them? Acceptance riteria heck 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 T7.1.2q2 When attribute data sampling, is the acceptance level zero defects? heck the inspection criteria. Yes, the acceptance level zero defects is applied T7.1.3q1 How does the organization ensure the confidentiality of customer-contracted products, projects under development, and related product information? onfidentiality By customer property (Q/YQP25-211) T7.1.4q1 What process is there to control and react to changes that impact product realization? hange ontrol hanges that happen during process development are monitored according to guidelines detailed in the procedure. (Q/YQP ) T7.1.4q3 Are changes validated before implementation? Yes, changes re-validated by a group of team members before to process. T7.1.4q5 Do you have evidence that any additional verification/identification requirements required by the customer are met? Yes, records are available q1a Does the organization determine requirements specified by the customer, including the requirements for delivery and post-delivery activities? ustomer-related Processes Determination of Requirements Related to the Product Yes, the organization determines requirements specified by the customer, including for delivery and PPM, as required by the procedure (Q/YQP31-28) and document them in (Q/YQP ). SEE PHOTO # q1b Does the organization determine not stated by the customer but necessary for specified or intended use, where known? Yes, it included in the document (Q/YQP ). SEE PHOTO # q1c Does the organization determine statutory and regulatory requirements related to the product? Yes, it is included in the document (Q/YQP ). SEE PHOTO #14.

16 AUDIT HEKLIST 7.2.1q1d = omplies with the requirements, I = Improvement Needed, N = Not omplies, N/A = Not Applicable Does the organization determine any additional requirements determined by the organization. EVIDENE TO HEK Yes, it is included in the document (Q/YQP ). SEE PHOTO #14. SORE T q1 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 VGS q1a What kind of review is done to ensure that the organization has the ability to meet requirements before committing to supply product? Review of Requirements Related to the 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 q1b How do you ensure that product requirements are defined and reviewed before committing to supply product? The procedure Q/YQOP is been developed to required a mandatory step to conduct the feasibility before launching the project q4 T q1 When product requirements are changed, how do you ensure that relevant documents are changed and that relevant personnel are made aware of the changes? What documents do you have that show investigation and confirmation of manufacturing feasibility in the contract review process for proposed products, including risk analysis? According to change procedure. There are a few examples of how changes were implemented. Yes, there are few case where feasibility were conducted q1 What method(s) are used to communicate with customers regarding - product information - enquiries, contracts, or order handling including amendments? - feedback, including customer complaints ustomer ommunication Procedure (Q/YQP ), via customer representative. 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 ustomer Rep. 7.3 Design and Development q1 an you explain to me the process used by the organization to plan and control the design and development of product? Design and Development Planning There is a procedure Q/YQP for development of process according to APQP / PPAP q2a What are the stages in the design and development process? There are four stages for the development, for example of the project VGS (OEM), for part E, the plan is documented in Q/YQP q2b 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 E, the plan is documented in Q/YQP q2c Are design and development responsibilities and authorities defined? Yes, responsibility is well defined. Example of part E, the plan is documented in Q/YQP43-4.