Manufacturing Audit Guideline Manual 0 Process_Audit_Check_List

GKN Driveline Period 3 2003 GKN Driveline Standard 008542_A Manufacturing Audit Guideline Manual MAGM First Issue Revision Prepared Approved April 1996 Revision # C Gary Rechtin Lutz Schulte Date: March 1999 This Manual is an official GKN Driveline publication and duplicates should not be made. GKN Driveline Period 3 2003 GKN Driveline Standard 008542_A Extra copies can be obtained via a GKN Driveline Line Company GKN Driveline Period 3 2003 GKN Driveline Standard 008542_A Contents: Purpose Field of Validity Procedure Related Standards Table of Contents Purpose: To verify that key manufacturing processes and components meet GKN Driveline and/or customer requirements. Field of Validity: This manual provides guidelines for auditing current and/or new processes and products at GKN Driveline manufacturing plants, Joint Venture companies, and suppliers. Procedure: The MAGM contains three audits – Process, Work Place and Product. They are appropriate for use on new suppliers, product launch preparation, new or existing processes, and new or existing products. At the discretion of the auditing body, only individual sections, i.e. Section C – In-Process Control or portions thereof, may be utilised for evaluation purposes, or to aid in problem resolution. Process audits are conducted utilising Sections A – H; Workplace audits – a subset of sections B – E, G, and H as indicated on the bottom of each page of questions; Product audits – Section I; Special audits – selected sections/questions from Sections A – H. Related GKN Driveline Standards: 300001 Data Interpretation for Normal Distribution 300002 Process Control Charts for Variable Data 300004 Individual Moving Range: Control Charts 300005 Stability Control 300006 Capability Studies 300007 Measurement System Variation 300500 Traceability 320011 Symbols for Critical and Significant Characteristics 300100 FMEA in Driveline 300200 Process Flow and Control Plan 400000 Product Test Standards 600466 Record Retention 003000 Manage Suppliers 003052 Reasons for Rejection GKN Driveline Period 3 2003 GKN Driveline Standard 008542_A TABLE OF CONTENTS 1. AUDIT QUESTINS AND GUIDELINES A Process Quality Planning 1 B Incoming Material 3 C In-process Control 5 D Inspection and Test 13 E Identification and Traceability 17 F Preventive and Corrective Action 19 G In-Process Handling 23 H Storage, Packaging, Preservation and Shipment 25 I Product Audit 27 2. APPENDICES: I Process/Workplace Audit Report Summary Sheet 29 II Process/Workplace Audit Scoring Summary Sheet 30 III Process/Workplace Audit Scoring and Deficiency Report Sheet 31 IV Product Audit Measurement Report 43 GKN Driveline Period 3 2003 GKN Driveline Standard 008542_A Page 1 of 42 Guidelines and suggested areas to be addressed A. PROCESS QUALITY PLANNING 1,2,3. Documentation which defines the process and product being audited should be available in a central location, and should contain the following: - Customer drawing or Contract - Control Plan* - Process F.M.E.A* - Process flowchart* - Initial sample documentation - Engineering change records Where these documents specify or refer to any additional information, this should also be made available. On this documentation, the part number and engineering level must be specified. The auditor will review this documentation and decide about its adequacy. NOTE: The entire planning documentation must be related to the same engineering level. 4. The critical and significant characteristics* should be identified on these documents according to the GKN Driveline Standard or customer requirement. All critical and significant characteristics should be monitored by SPC and also identified on these documents. When SPC is not used, the auditor will evaluate the adequacy of the quality assurance practices. 5,6 The documentation should reflect any process changes. There should also be evidence of customer approval for these changes. 7. Documentation supporting the initial sample approval should be available. It should contain the initial sample certification, test and measurement results, gauge R & R studies for new gauges, and Ppk\Cpk studies. This data should demonstrate the conformity of the product. A corrective action plan (CAP) should be available for all non-conformities. The Initial Sample Inspection Report (ISIR) should also reflect any engineering level change. Related GKN Driveline Standards:* 320011 Symbols for Critical and Significant characteristics. 300200 Process Flow and Control Plan 300100 FMEA in Driveline GKN Driveline Period 3 2003 GKN Driveline Standard 008542_A Page 2 of 42 Question Notes Result A. PROCESS QUALITY PLANNING 1. Are FMEA’s, Control Plans, and Instruction sheets available, linked, and complete (via cross-functional teams) with proper approval. 2. Are all other documents available for Quality Planning purposes? 3. Are all QP documents to the latest engineering level? 4. Are Critical and Significant characteristics identified on the control plans and instruction sheets and appropriately monitored? 5. Are process changes incorporated in this documentation? 6. Is there evidence of customer approval for process changes? 7. Is the Initial Sample file available, complete, and approved by the customer? GKN Driveline Period 3 2003 GKN Driveline Standard 008542_A Page 3 of 42 Guidelines and suggested areas to be addressed B. INCOMING MATERIAL 1. The supplier should have a documented system for assuring the quality of incoming products, consumables and services. The responsibilities for auditing or inspection of incoming goods must be clearly defined by the work instructions. 2. There should be a list of approved suppliers available from which products, consumables and services can be procured. This should be available for reference. 3. Incoming materials should be approved for production by initial sample pass-off. Records of the inspections and subsequent approval should be available for inspection. This should include multiple raw material sources (i.e. two different steel suppliers for one forging.) 4. Materials should be audited on a regular basis prior to use. A schedule should exist. (Ultimately, the goal is to eliminate incoming inspection – material audits are an interim measure.) 5. Sampling plans should be employed to minimise the receiving inspection. The sampling plan employed must be based on zero defect. 6. Supplier performance should be monitored using the information gathered from receiving inspection, with feedback to the purchasing function. Sampling levels should be adjusted according to the suppliers performance. 7. Conformance of the incoming materials should be monitored using statistical techniques such as SPC and/or other records. Wherever possible suppliers shall supply initial process capability data in the form of a Ppk study. 8. Records should be available so that all aspects of the part’s history can be easily examined. 9. A documented procedure for reaction to non-conforming products should exist whereby the rejected materials can be bonded pending sort or returned to the supplier. 10. These procedures should also ensure that the supplier is promptly informed of any non-conformance by issue of a concern notice*. A concern report* showing the corrective action plan must then be submitted by the supplier and updated as appropriate until closure. Related GKN Driveline Standards:* 003000 Manage Suppliers 003052 Reasons for Rejection Concern Report GKN Driveline Period 3 2003 GKN Driveline Standard 008542_A Page 4 of 42 Question Notes Result B. INCOMING MATERIAL 1. Have the responsibilities for the control of incoming material been defined in procedures and instructions? 2. Does the supplier have an approved supplier list? 3. Are incoming materials approved for production? 4. Are materials inspected prior to release to production per documented procedures? 5. Is a sampling plan used? If so, is it based on a zero defect acceptance criteria? 6. Is supplier performance monitored and sampling levels adjusted as required? 7. Is the product conformance monitored through submission of SPC data and/or other records? 8. Do records detail the material history? 9. Is the reaction to non-conforming products well defined? 10. Are suppliers informed in the event of a non-conformance and is corrective action feedback timely, appropriate, implemented and effective? (Work place audit: Items 3 – 10) GKN Driveline Period 3 2003 GKN Driveline Standard 008542_A Page 5 of 42 Guidelines and suggested areas to be addressed C. IN-PROCESS CONTROL 1. During the manufacturing process, capability should be established for all GKN Driveline and customer designated critical and significant characteristics. Capability studies where applicable should be conducted in line with the relevant GKN Driveline Standard. 2. Critical and significant characteristics* should be identified on all documents as specified by the customer or as defined in the relevant GKN Driveline standard in all other cases. 3. It is essential that all customer Cpk criteria (where applicable) are met. In the absence of any documented standard approved by the customer, the level of control should be based on the capability of the process. 4. Documented Corrective Action Plans (CAPs) must be initiated for any process which fails to meet the minimum acceptance criteria. 5,6. Control charts or other suitable means shall be used to monitor the process. All SPC charts should be reviewed on a regular basis for proper charting techniques and then filed for reference purposes. A procedure for the reaction to special cause variation should exist. 7. The use of mistake-proofing is encouraged. 8. Where mistake-proofs are in use they should be checked at periodic intervals to ensure correct operation. These checks should be documented and be available for review at the point of use. 9,10. Instructions for process set-up inspection and routine maintenance should exist at each workstation. Each sheet should contain at least identification of the part including part number and engineering level, and characteristics to be controlled along with checking frequencies, sample size and gauging requirements (or mistake-proofing when used). Instructions in case of non-conformity and the use of SPC (interpretation of charts) should also be available. Process flow routes must be documented. Any deviation from the defined route may require internal approval in addition to customer approval. TPM (Total Productive Maintenance) schedules should be developed and evidence of adherence to these schedules available. The auditor should satisfy him/herself that all inspections and measurements are completed as required. The records available must show that the checks are consistently carried out. GKN Driveline Period 3 2003 GKN Driveline Standard 008542_A Page 6 of 42 Question Notes Result C. IN-PROCESS CONTROL 1. Has process capability been established for all critical and significant features and process parameters? 2. Do symbols appear on process documents and equipment when critical or significant features are present? 3. Do all these features meet GKN Driveline and/or customer requirements? 4. Do CAPs exist for all features which do not meet GKN Driveline and/or customer requirements? 5. Is process capability monitored, and are all process records and charts current and correctly completed? 6. Are SPC charts analysed for trends and acted upon for continuous improvement opportunities? 7. Where mistake-proofing devices are used, do they function correctly? 8. Are verifications of mistake-proof device operation carried out per established schedules? 9. Are clear, concise work, inspection and set-up instructions (including SPC and TPM guidelines) available at the workstation? 10. Are inspections and measurements being performed according to the instructions? (Work place audit: Items 5, 7 – 10) GKN Driveline Period 3 2003 GKN Driveline Standard 008542_A Page 7 of 42 Guidelines and suggested areas to be addressed C. IN-PROCESS CONTROL (cont.) 11. Process parameters that can have a significant impact on part quality should be identified. They include, but are not limited to machine feeds and speeds; induction hardening parameters such as power, time, quench delay; and furnace settings such as time and temperature. 12. It should be evident, from documented procedures, who identifies these parameters, and who approves them. Evidence should indicate that the process is followed. 13,14. If operators are expected to know, verify, or change any identified process parameters, then those parameters should be available in the work area, and acceptable operating ranges should be clearly stated. 15. Operators must understand which parameters they are required to set or verify, and what the acceptable operating ranges are for those parameters. 16,17. If the specified operating range, as documented in work instructions, will not yield acceptable product, the operator’s reaction should be clearly defined and understood. A review of the process should indicate operator understanding and adherence to those reaction instructions. 18. If it becomes necessary to change any of the process parameter specifications, that process should be defined, understood and followed. It should be possible to review objective evidence to substantiate compliance with process change control requirements. 19. Auto feedback devices such as furnace temperature controllers must be identified and calibrated on a routine basis. 20. When defined process parameters are out of control, operator reaction instructions must be clearly defined, including how affected material will be reviewed and dispositioned. GKN Driveline Period 3 2003 GKN Driveline Standard 008542_A Page 8 of 42 Question Notes Result 11. Is there a process to identify critical process parameters, i.e., feed rates, speeds, power settings, temperature, etc. 12. Is identification and approval of critical process parameters documented? Is the process proceduralised and followed? 13. If documented, are the parameters readily available in the work area? 14. Are acceptable operating ranges (min, max) for each parameter defined and documented in the work area? 15. Are operators required to set or verify these parameters; i.e. are operators fully knowledgeable of the procedure, requirements and acceptable operating ranges? 16. Is it clearly defined what the operator’s reaction must be if operating within the acceptable parameter ranges will not yield acceptable product? 17. Is there evidence that this ‘reaction’ is actually practiced? 18. Within the work area, is process change control defined, proceduralised, understood, followed and effective? 19. Where process controls consist of auto- feedback devices or controllers, are they audited/ calibrated/under change control as required? 20. Are reactions to out-of-control process situations clearly defined, understood, documented and practiced in the work area? (Work place audit: Items 11, 13 –20) GKN Driveline Period 3 2003 GKN Driveline Standard 008542_A Page 9 of 42 Guidelines and suggested areas to be addressed C. IN-PROCESS CONTROL (cont.) 21. When process parameters are important for achieving product quality and meeting drawing specifications, they should be addressed in the PFMEA. 22, 23. Often, special training and/or certification is required of operators who will be operating identified special processes. Objective evidence should be available where training on these special processes is required; evidence of the training program itself, as well as certificates of completion or other documented evidence of completion. Responsibility for execution and verification of these plans should be defined. 24. Where appropriate, additional visual aids should be available to assist the operator in the decision making process. These documents or physical samples should be periodically reviewed to ensure continued validity and to check for degradation. These reviews should take place in a timely manner. 25. The authorisation for the start of production should be available. This may be by the signature of the person responsible for the first part manufactured. NOTE: Retention of the first-off part is not mandatory. 26. Clearly identified containers should be made available for both scrap and rework. All non-conformities must be clearly identified and a decision between scrap or rework made. Quarantine area should be available to store non-conforming parts and parts awaiting inspection. These areas must be lockable. 27. Analysis to determine causes and identify trends should be carried out. 28. Where non-conforming material requires rework, instructions outlining the approved rework procedures should be available. 29. All reworked products should be audited for conformance following any rework operation. Critical and significant characteristics should be assured prior to release. 30. The general manufacturing environment should be clean and well organised with specially designated areas for tooling and part storage. GKN Driveline Period 3 2003 GKN Driveline Standard 008542_A Page 10 of 42 Question Notes Result 21. Does the current PFMEA identify and address key process parameters? 22. Are operators of these “special process” required to be formally trained and/or certified? If so, are they? 23. Is there a documented, up-to-date training/certification plan for these operators? Is the responsibility for executing/verifying these plans defined? 24. Are visual aids utilised to communicate acceptable/unacceptable standards in the case of visual inspections? 25. Is first piece inspection carried out and documented? 26. Are all non-conforming parts clearly identified, documented and controlled? 27. Are causes of scrap/rework analysed and CAPs formulated and implemented? 28. Are rework methods documented and approved? 29. Is rework on critical/significant characteristics assured? 30. Are the work areas clean, well lighted, organised, and ergonomic? (Work place audit: Items 24 – 26, 28 – 30) GKN Driveline Period 3 2003 GKN Driveline Standard 008542_A Page 11 of 42 Guidelines and suggested areas to be addressed C. IN-PROCESS CONTROL (cont.) 31. Communications across shifts is important and is encouraged. While numerous techniques are available to accomplish this, some type of effective communication system is needed. 32. Well defined and operated manufacturing processes are necessary in order to meet customer requirements. This section is intended to explore that customer requirements regarding quantities quoted can be met. Related GKN Driveline Standards:* 300001 Data Interpretation for Normal distribution 300002 Process Control Charts for Variable data 300004 Individual Moving Range: Control charts 300005 Stability Control 300006 Capability Studies 320011 Symbols for Critical and Significant characteristics 003000 Manage Suppliers 003052 Reasons for Rejection GKN Driveline Period 3 2003 GKN Driveline Standard 008542_A Page 12 of 42