In many cases, preliminary studies should be conducted at several points in the evolution of new processes e. These studies should be based on as many measures as possible. When utilizing X-Bar and R charts, at least twenty-five subgroups minimum of four pieces per sub-group are required to obtain sufficient data for decision-making.
When this amount of data is not available, control charts should be started with whatever data is available, or contact the authorized customer representative to develop a suitable plan. The purpose of the initial process study is to understand the process variation, not just to achieve a specific index value. When historical data are available or enough initial data exist to plot a control chart at least individual samples , Cpk can be calculated when the process is stable.
Otherwise, for processes with known and predictable special causes and output meeting specifications, Ppk should be used. There are receipts for referenced part and duns number within the previous six months.
S-IpB for a supplier manufacturing duns is calculated monthly using the following formula: 1. Each Quality PRR receives a weight factor based on the documented impact towards the GM final customer, manufacturing plant and product 2. Divide by total receipts in the last 6 months for that location 4.
Multiply by 1,,, Also included are organizations who are providers of heat-treating, painting, plating or other finishing services. Requirements 4. See cl. Any other language translations are not authorized. NOTE: A process and plan with implementation monitoring for assurance of qualified internal auditors is evidence of compliance.
The frequency of these reviews shall be appropriate to the sub-tier supplier impact on customer satisfaction. Also included are providers of heat-treating, painting, plating or other finishing services. Indirect and service providers are not included in this requirement, e. NOTE 2: The use of customer-designated suppliers to the organization subcontractors does not relieve or eliminate the responsibility of the supplier for ensuring the quality of subcontracted parts, materials and services.
The statement of authorization below provides the requirements and conditions for GM approval. The organization that utilizes 2nd party assessment to comply with clause 7.
GM-approved 2nd Party requirements: 1. The organization 2nd Party must audit annually each qualifying supplier for whom it has performed a 2nd Party assessment, and maintain records of these audits.
Any of the IATF recognized and currently approved auditors may perform such audits when contracted by the organization.
Such decision criteria will be in writing, and applied consistently in the application of this provision. The existence and use of such decision criteria shall be verified by 3rd party auditors. NOTE 1: 2nd Party assessment by a competent auditor and meeting the above requirements will satisfy the self-assessment requirement. NOTE 2: Implementation effectiveness should be based on evidence that the organization has a process in place that includes elements such as auditors identified, schedule for self-assessment in place including schedule adherence, supplier development process identified for applicable suppliers, monitoring of progress, defined corrective action process and record-keeping.
This requirement shall also apply to sub tier suppliers to the organization that provide product manufactured using the techniques described in section 1. The following clauses, 4. Conforming material is handled, stored and identified appropriately. A containment method is in place to ensure that an effective breakpoint has been established. Containment activities and results are documented. Traceability is applied according to the traceability methods of the finished product. Confirm that conforming material is handled, stored and identified appropriately.
Red, Yellow, Green stoplight approach is adhered to for foot printing, containerization, table marking and tagging. Audit that all parts removed from the process are identified, accounted for FTQ , and reconciled to eliminate mishandling of material. Verify use of Department Containment Worksheets, with potential parts locations by operation identified to ensure no parts are missed during a containment and all parts are reconciled. The containment worksheets must cover from the incoming material, process and shipment.
Auto Reject stations with Locked reject bins, with controls on how bins are emptied to ensure all parts are reconciled. Parts should be physically tagged or painted for identification purposes and to drive a physical act during handling, which will reduce the chances of Mis-handling parts. Records shall be maintained. NOTE — Look at: Layered audits are in place to assess compliance to standardized processes, to identify opportunities for continuous improvement, and to provide coaching opportunities.
Layered audit process is led by Management who are competent to conduct the audits. Follow up to address noncompliance is in place. Look for: Layered Audit is utilized as an effective tool to confirm the processes are operating at standard, and enhance continuous improvement.
Leadership utilizes an audit process by going and seeing on the shop floor to check process compliance, employee behavior and knowledge. Leadership uses Layered Audit as an opportunity for coaching. Recognition is used to reinforce the right behaviors. Ask Leadership how Layered Audit works in the organization, who is involved in the layered audit process, what is the frequency of layered audits.
Is the layered audit sheet content relevant for the user have each principle calibrator review respective part of the audit sheet? Check that all findings are recorded on the audit sheet and those not solved within the shift are transferred to countermeasure sheets. Managing Risk 4. PFMEA workshops must be done by cross functional teams, including manufacturing team member input.
NOTE — Look at: Monthly RPN risk reduction reviews by product focused on preventing defects from leaving the work station are held to drive continuous improvement. Action plans for top issues must include: 1. Recommended actions, 2. Responsibility, 3. Reverse PFMEA process is in place to identify new potential failure mode in the shop floor Look for: For evidence of monthly cross functional risk reduction reviews focused on preventing defects from leaving the work station.
Confirm action plans for top issues include: 1. Plant Management shall be included in top risk reporting and approval of countermeasures. NOTE — Look at: The plant shall identify manufacturing processes and error proofing devices which can be bypassed. Standard work instructions are available for each Bypass process. Implemented bypasses are reviewed in daily Leadership Meeting with the goal to reduce or eliminate bypassed operations. Restart verification is documented for defined period e.
Ensure implemented bypasses are reviewed in Fast Response with the goal to reduce or eliminate bypassed operations. Error Proofing 4. NOTE — Look at: All Error Proofing Devices are checked for function failure or simulated failure at the beginning of the shift, when feasible, otherwise according to the process control plan.
Records of verification are available. Look for: Confirm that a list of error proofing devices is available. Confirm that the method of the error proofing verification is defined and documented in the standardized work. Verify that all error proofing devices are checked for function failure or simulated failure at the beginning of the shift, when feasible, otherwise according to the process control plan. Look to see that error proofing masters when used are clearly identified.
Confirm records of verification are available. Verify that a reaction plan is available in the event of error proofing device failure and is understood by the team member. Gage Control 4. Note — Look at: Gage capability e. Check that no gages are past due for calibration. Write down 3 gage numbers at random and verify they are in the gage control system and on some calibration schedule.
Fast Response 4. Plant Quality Manager ensures the applicability and the timely completion of the items being tracked. Plant Staff level personnel actively participate in daily meeting. There is read across of corrective actions to like operations. Confirm that the Plant QM ensures the applicability and the timely completion of the items being tracked. Confirm that the plant staff level personnel actively participate in daily meeting.
Verify that the required documents are reviewed and updated e. Confirm that there is read across of corrective actions to like operations. Formal problem solving activities are initiated according to a specified criteria.
Issues are identified, root causes analyzed and robust actions completed in a timely manner. Problem solving is driven at the Team level and all Teams are involved. Leaders are actively involved coaching and guiding the process.
Look for: Common methods for solving problems that are understood and used by all. A standardized problem solving process exists. A range of problem solving activities are conducted for different problem types and complexities, including single special cause, common repetitive cause, as well as more complex multiple-cause problems.
Ask to talk through some problems with Team Leaders and Supervisors. Ask how many formal problem solving activities the team has worked on in recent months? All teams should be involved in problem solving activities. There should be a standardized process that includes: issue description and definition, containment, probable cause analysis, root cause analysis 5 Whys , countermeasures, implementation plan, verification, approval to close, and escalation or read across if needed.
Look for Leadership involvement reviews, coaching, escalation, support, read across 4. High risk quality focused items from customer feedback and problem solving are included in the Quality Focused audit, or other suitable checklist, and checked each shift. In many cases, preliminary studies should be conducted at several points in the evolution of new processes e. These studies should be based on as many measures as possible. When utilizing X-Bar and R charts, at least twenty-five subgroups minimum of four pieces per sub- group are required to obtain sufficient data for decision-making.
When this amount of data is not available, control charts should be started with whatever data is available. See Production Part Approval Process manual. PPM data can be used to prioritize corrective actions. Definition of defective units varies with customer e. Also included are providers of heat-treating, painting, plating or other finishing services. Quality performance records e. Records of internal quality system audits and management review shall be retained for three years.
Retention periods longer than those specified above may be specified by an organization in their procedures. The organization shall eventually dispose of records.
These requirements do not supersede any regulatory requirements. For EDI assistance, contact See cl. See also the Production Part Approval Process manual.
Any other language translations are not authorized. NOTE: A process and plan with implementation monitoring to assure qualified internal auditors is evidence of compliance.
Indirect and service providers are not included in this requirement, e. Note: The use of customer-designated suppliers to the organization subcontractors does not relieve the supplier of the responsibility for ensuring the quality of subcontracted parts, materials and services. The statement of authorization below provides the requirements and conditions for GM approval. A supply organization that utilizes 2nd party assessment to comply with clause 7. GM-approved 2nd Party requirements: 1.
The supply organization 2nd Party must audit annually each qualifying subcontractor for whom it has performed a 2nd Party assessment, and maintain records of these audits. Any of the IATF recognized and currently approved auditors may perform such audits when contracted by the supply organization.
The organization shall have decision criteria in writing, approved by the customer and applied consistently to determine the specially designated suppliers for which this provision may apply. Such certification shall include the requirements in this document, or in the case of QS, the General Motors-Specific Requirements. See also 4.
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