RUN @ RATE GP-9 - Risk Analysis, Quality Assurance, ISO ...



RUN @ RATE GP-9

I. PURPOSE

The purpose of a Run @ Rate is to verify:

A. the supplier's actual manufacturing process is capable of producing components that meet GM's on-going quality requirements, as stated in the Production Part Approval Process (PPAP), at quoted tooling capacity for a specified period of time; and

B. the supplier's actual manufacturing process conforms to the manufacturing and quality plan documented by the supplier in PPAP, GP-12 and other required documentation.

During a Run @ Rate, all production tooling is to be in place and running at full capacity, utilizing all regular production, direct and indirect, personnel and support systems.

II. SCOPE

All new parts require a Run @ Rate, unless exempted by the supplier quality engineer and approved by the Supplier Quality and Purchasing Directors of the procuring division.

III. SELECTION PROCESS

All new part numbers will be evaluated by GM, taking into consideration factors such as the following: history; new technology; irreversible tooling changes; and new supplier facilities. The need for the Run @ Rate will be confirmed by the Supplier Quality Engineer, and approved by the Supplier Quality and Purchasing Director(s) of the procuring division. The supplier will be notified of the need to perform a customer monitored or supplier monitored Run @ Rate as early in the Advanced Product Quality Planning Process as possible. Note: See Section VIII for Additional Requirements for Supplier monitored Run @ Rate.

IV. GENERAL INFORMATION

A. DURATION OF RUN @ RATE

The number of components to be produced during the Run @ Rate should be sufficient to demonstrate manufacturing process capability and should be predetermined by the supplier and the procuring division's Supplier Quality Engineer(s). Factors such as product complexity, shelf life, storage, cost and single shift vs. multiple shift operations are taken into consideration in determining the length of the Run @ Rate. The default length of the Run @ Rate is one day of the customer's daily production requirement at full acceleration.

B. TIMING OF RUN @ RATE

The Run @ Rate should be performed after the supplier has attained an acceptable PPAP submission and prior to start of production acceleration. Although encouraged to be performed as early as possible, a key consideration in establishing the Run @ Rate date is the stability of the design. The exact date should be predetermined by the procuring division and the supplier.

C. REQUIRED PARTICIPATION

1. Customer Monitored –

Customer - A representative from the procuring division is to be present for the entire Run @ Rate. No portion of the Run @ Rate is to be performed without representation of the procuring division, without prior approval. The lead GM representative typically will be the Supplier Quality Engineer, with participation of the Buyer and/or Release Engineer upon request.

Supplier - The lead supplier representative is to be the project manager or manager appointee.

2. Supplier Monitored –

The lead supplier representative is to be the project manager or manager appointee.

Note: Equipment and/or subcontractors may be asked to participate.

D. SUPPLIER PREPARATION FOR RUN @ RATE.

To make effective use of time, the supplier should conduct a practice Run @ Rate and/or production simulations, as well as complete as much of the Run @ Rate Worksheet (Attachment B), before the official Run @ Rate is conducted.

E. INVENTORY.

If parts are produced ahead of production schedules, the supplier will hold all parts produced until authorized to ship. The supplier will ensure that sufficient production containers and packaging are available to prevent part damage.

V. RUN @ RATE REVIEW CONTENT

The Run @ Rate will verify that the results of the supplier's actual manufacturing process meet customer requirements for on-going quality, as stated in PPAP, and quoted tooling capacity. Also, it will verify that the supplier's actual process is to plan, as documented in PPAP, GP-12 and the other documentation listed below.

During the Run @ Rate, the following will be reviewed: documentation; the manufacturing process and results; part quality requirements and results; sub-supplier requirements and Run @ Rate results; and packaging.

A. DOCUMENTATION:At the time of the Run @ Rate, the following support documentation should be available for review:

1. PPAP package including:

a) Process flow diagram

b) Process control plan, with reaction plan

c) DFMEA/PFMEA

d) Master part(s)

2. GP-12 (Pre-launch) control plan

3. Tool capacity information

4. Operator/inspection instructions

5. Prototype/pilot concerns (PR/R's)

6. Sub-contractor control/capacity data

7. Sub-contractor material schedules and transportation

8. Packaging/labeling plan

9. Acceleration plan.

Note: All documentation must be complete and correct.

B. MANUFACTURING PROCESS – ACTUAL TO PLAN

1. The product is being manufactured at the production site using the production tooling, gaging, process, materials, operators, environment, and process settings.

2. The actual process flow agrees with the process flow diagram, as documented in PPAP.

3. Operator instructions/visual aids are available and adhered to at each work station.

4. All in-process documents, such as process control charts, are in place at the time of the Run @ Rate. The documentation is utilized to drive a defined reaction plan and corrective action process.

5. Production boundary samples, when required, are available at required work stations.

6. Maintenance plans are in place; repair and maintenance parts are available; and there is planned downtime for preventative maintenance.

Note: All of the preceding requirements must be met to pass the Run @ Rate.

C. MANUFACTURING CAPACITY RESULTS

The following will be verified while the process is running.

1. Net output from each operation can support quoted capacity.

2. During the Run @ Rate, the tooling must meet the quoted up time requirements (net vs. gross quoted output). Any unexpected downtime must be documented and corrective action taken.

3. All line changeovers, if any, can be performed within the quoted tooling capacity requirements.

4. The net through-put of good pieces (scrap taken out, any allowable rework) meet daily quoted capacity.

5. The acceleration plan is sufficient to meet requirements.

Note: All of the preceding five requirements must be met to pass the Run @ Rate.

D. PART QUALITY PLAN TO ACTUAL

1. All production checking fixtures must be complete, with acceptable measurement system studies (i.e., gage R and R) performed, and operator instructions/visual aids available.

2. All in process gaging and controls must be complete, functional and in place.

3. The process control plan (normal and GP-12) must agree with the actual process. Production part checks and statistical monitoring must take place as outlined on the process control plan.

4. Potential failure modes, as identified in the PFMEA, are addressed through error-proofing or the control plan.

5. The process control plan reaction plan as well as the supplier's corrective action process to ensure containment and correction should be available for review.

Note: All of the preceding five requirements must be met to pass the Run @ Rate.

E. PART QUALITY RESULTS

1. All parts produced off production tooling during the Run @ Rate meet GM's requirements for ongoing quality, as stated in PPAP.

2. The manufacturing process is in control.

3. The manufacturing process demonstrates the required capability.

4. The process control plan is sufficient to effectively meet the design record requirements (i.e., control points, frequency of checks, etc.).

5. Nonconformances

Note: The total number of parts produced, the pieces rejected and the pieces reworked need to be documented on the summary sheet.

a) The non-conformances yielded by the process were identified by the normal PPAP control plan. If identified by the GP-12 Process Control Plan or an activity outside documented plans, corrective action is required.

b) The PFMEA identified the potential failure modes. If not, the PFMEA needs to be updated and corrective action put in place.

c) All rework and repairs effectively correct the nonconformance(s).

d) All prototype and pilot concerns, if any, have been corrected and validated.

Note: All of the preceding five requirements must be met to pass the Run @ Rate.

F. SUBCONTRACTOR REQUIREMENTS

1. Subcontractor(s)' abilities to meet the customer's quality and capacity requirements must be confirmed by the supplier prior to the Run @ Rate being conducted at the supplier's facility. Verification of the subcontractor(s)' manufacturing processes should be accomplished through a Run @ Rate or similar process conducted by the supplier.

2. Controls must be in place to isolate incoming material until it has been approved.

Note: The preceding requirements must be met to pass the Run @ Rate.

G. PACKAGING AND HANDLING

1. In process and final shipment packaging will be reviewed for preservation of part quality and ease of use by supplier's operators loading and unloading parts. (Refer to GM 1738 for requirements.)

2. The supplier's method for in process and final shipping packaging and handling must effectively eliminate the potential for process errors or mixed stock.

VI. CORRECTIVE ACTIONS REQUIRED

A. Actual to Requirements. If the results of the actual manufacturing process do not meet customer requirements for on-going quality and quoted tool capacity, corrective action must be taken to correct any non-conformances.

B. Actual to Plan. If the manufacturing and quality plan do not agree with the actual process, changes must be made to bring them into agreement.

C. Nonconformances. If nonconformances occurred during the Run @ Rate which were not identified previously by the normal PPAP control plan, a corrective action plan needs to be put in place (i.e., error proofing or a change in the control plan) and documented in the PFMEA and/or process flow diagram.

VII. APPROVAL

Upon completion of the Run @ Rate, the worksheets must be reviewed for completeness and a decision made whether or not to approve the review. The Run @ Rate can have one of three results: pass; open or fail.

A. Pass

1. Definition

Pass indicates that all Run @ Rate requirements were met. The supplier demonstrated the capability to produce parts that meet GM's on-going quality requirements at quoted capacity (net output). All key product characteristics were monitored and meet Cpk/Ppk requirements. GP-12 requirements were met. The supplier's actual manufacturing process agreed with the manufacturing and quality plan, as documented by the supplier in PPAP, GP-12 and other required documentation. Quality systems were documented and practiced.

B. Open

1. Definition Open indicates that some minor non-conformances to the requirements were found that need to be corrected. Examples of this are net output meets volume requirements but not quoted capacity; quality systems have minor deficiencies (i.e., preventative maintenance system lacking, lack of error proofing, incomplete or inadequate operator instructions/visual aids, operator training not complete, minor deficiencies in meeting customer's ongoing quality requirements).

2. Corrective Action Required A documented Action Plan to correct the non-conformances is required. At a minimum, it must include the name of the individual at the Supplier who is responsible for implementing the Corrective Action and the timing and validation of the Corrective Action Plan. This plan is due to the GM Run @ Rate Supplier Quality Engineer for approval, within two (2) business days of the completion of the Run @ Rate.

3. Verification of Corrective Action GM verification of successful completion of the corrective action plan can be accomplished in several different ways, for example, through correspondence, a part review or a plant visit. Generally an additional Run @ Rate is not required. Once the Corrective Action plan is successfully completed, the Supplier Quality Engineer will change the Run @ Rate result from open to pass.

C. Fail

1. Definition Fail indicates a serious non-conformance exists that requires significant action by the supplier to correct, such as quality systems are not in place and serious non-conformances exist; Ppk values (Cpk values) do not meet requirements for KPC’s; or supplier fails to meet Volume Requirements. An additional Run @ Rate will be required.

2. Corrective Action Required A documented Action Plan to correct the non-conformances is required. At a minimum, it must include the name of the individual at the Supplier who is responsible for implementing the Corrective Action and the timing and validation of the Corrective Action Plan. This plan is due to the GM Run @ Rate Supplier Quality Engineer for approval, within two (2) business days of the completion of the Run @ Rate.

3. Verification of Corrective Action. Once the Corrective Action plan is completed, the Supplier Quality Engineer will schedule the new Run @ Rate to verify the successful implementation of the corrective action plan.

VIII. Supplier Monitored Run @ Rate Additional Requirements

A. All Run @ Rate requirements identified in Sections IV. V, VI and VII of this procedure apply to both supplier monitored and customer monitored Run @ Rates.

Note: The scheduled date for the Run @ Rate must be approve by The Supplier Quality Engineer.

B. Since a customer representative will not be present during the Run @ Rate, the following must be completed.

1. Within twenty-four hours of completing the scheduled Run @ Rate, the supplier must complete the Run @ Rate Summary and Worksheets (Attachments A and B) and provide them to the responsible customer Supplier Quality Engineer, with a recommendation for the result of the Run @ Rate.

2. In addition, if any non-conformances were identified, the supplier will develop and implement a corrective action plan, using Sections VI and VII as reference. Within two days of completing the scheduled Run @ Rate, the supplier will provide this information to the responsible customer Supplier Quality Engineer.

3. Based on the information provided by the supplier, the customer Supplier Quality Engineer will:

a) Determine whether the Run @ Rate results in a pass, open or fail.

b) Review and approve the corrective action plan.

c) Determine the need for an additional Run @ Rate.

d) Communicate the results of the above review to the supplier.

4. If the result of the Run @ Rate is open or fail, the process described in Section VII applies.

Note: If the supplier monitored Run @ Rate results in a fail, another Run @ Rate must be scheduled with a customer representative present

GP-9 RUN @ RATE SUMMARY

ATTACHMENT A

Part Description_______________________________________

Supplier_____________________________________________ Part #_________________

Mfg. Location____________________________ Z-code_______ Drawing #______________

Supplier Quoted Production Rate _________/Hr _________/Day Change Level___________

Customer______________________________________ Buyer_______________________________

Phone #

Planned Usage: Daily____________ Weekly__________ SQE________________________________

Phone #

Planned Run Date_____________________________________ GOAL (net good parts)

Planned Hours To Run__________________________________ ___________________/Hour

Planned Shifts_______________ Planned Downtime__________ ___________________/Shift

Reason for Planned Downtime: ___________________________ ___________________/Day

RESULTS

Actual Hours______________ From _________ To__________ ACTUAL (net good parts)

Actual Shifts______________ Date ____________ ___________________/Hour

Actual Downtime Hours _____________(planned & unplanned) ___________________/Shift

Explain: _______________________________________ ___________________/Day

______________________________________________

______________________________________________

Total Produced _____________________ - Total Rejected ______________________ = Net _____________

Comments/Open Issues:

_________________________________________________________________________________________

_________________________________________________________________________________________

Supplier Run At Rate Recommendation: PASS OPEN FAIL Rerun Date________

Comments: _______________________________________________________________________________

_________________________________________________________________________________________

_________________________________________________________________________________________

__________________________ _________________ _______________ ___________

Supplier Signature Title Phone Date

For Customer Monitored Run At Rates

Run At Rate Summary: PASS OPEN FAIL Rerun Date_______

_________________________________________ __________________________ _______________

Authorized Customer Supplier Quality Signature Title Date

Attachment A to GM-1960 GM-1965 (2/95)

COMMENTS:

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

____________________________________________________________________________________

1965

RUN @ RATE GP-9 -- RUN @ RATE WORKSHEET

ATTACHMENT B

Supplier Name: _________________________________ Part Number(s):___________________________

RUN @ RATE REVIEW CONTENT

The Run @ Rate will verify that the results of the supplier’s actual manufacturing process meet customer requirements for on-going quality, as stated in PPAP, and quoted tooling capacity. Also it will verify that the supplier's actual process is to plan, as documented in PPAP, GP-12 and the other documentation listed below.

During the Run @ Rate, the following will be reviewed: documentation; the manufacturing process and results; part quality requirements and results; sub-supplier requirements and Run @ Rate results and packaging.

A. Documentation

At the time of the Run @ Rate, the following support documentation should be available for review:

Available Y/N

1. PPAP package including: 1.______

a) process flow diagram a._____

b) process control plan, with reaction plan b._____

c) DFMEA/PFMEA c._____

d) Master part(s) d._____

2. GP-12 (Pre-launch Control) plan 2.______

3. Tool capacity information 3.______

4. Operator/inspection instructions 4.______

5. Prototype/pilot concerns (PR/R's) 5.______

6. Sub-contractor control/capacity data 6.______

7. Sub-contractor material schedules and transportation 7.______

8. Packaging/labeling plan 8.______

9. Acceleration plan 9.______

Note: All documentation must be complete and correct.

B. MANUFACTURING PROCESS -- ACTUAL TO PLAN

1. Is the product being manufactured at the production site using the production tooling, gaging, process, materials, operators, environment, and process settings? Yes _____No _____

Comments:_______________________________________________________________________________

________________________________________________________________________________________

2. Does the actual process flow agree with the process flow diagram, as documented in PPAP? (Review the facility plan and layout. Walk the process with the flow diagram.) Yes _____No _____

Comments:_______________________________________________________________________________

________________________________________________________________________________________

3. Are operator instructions/visual controls available and adhered to at each work station?

Yes _____ No _____ Comments:_____________________________________________________________

________________________________________________________________________________________

4. Is all in-process documentation, such as process control charts, in place at the time of the Run @ Rate? Is the documentation utilized to drive a defined reaction plan and corrective action process?

Yes_____No_____Comments:_______________________________________________________________

________________________________________________________________________________________

5. When required, are production boundary samples available at required work stations? Are the boundary samples approved by GM? Yes _____No _____ Comments:_______________________________________

________________________________________________________________________________________

6. Are maintenance plans in place? Are repair and maintenance parts available? Is there planned downtime for preventative maintenance? Yes _____No _____ Comments: _______________________________________

________________________________________________________________________________________

Note: All of the preceding requirements must be met to pass the Run @ Rate.

Attachment B to GM-1960 GM-1965 (2/95)

RUN @ RATE GP-9 -- RUN @ RATE WORKSHEET

ATTACHMENT B

Supplier Name: __________________________________ Part Number(s): _________________________________

C. MANUFACTURING CAPACITY RESULTS

The following will be verified while the process is running.

1. Can net output from each operation support quoted capacity? Yes _____ No _____

Comments:__________________________________________________________________________________

Operation Quoted Capacity Rate

_________________________________________ ____________________ _________________

_________________________________________ ____________________ _________________

_________________________________________ ____________________ _________________

_________________________________________ ____________________ _________________

_________________________________________ ____________________ _________________

_________________________________________ ____________________ _________________

_________________________________________ ____________________ _________________

_________________________________________ ____________________ _________________

_________________________________________ ____________________ _________________

2. During the Run @ Rate, did the tooling meet the quoted up time requirements (net vs. gross quoted output)? Make note of any unexpected downtime and corrective action plans required. Yes _____ No _____ Comments: ______________________________________________________________________________

________________________________________________________________________________________

3. Can all line changeovers, if any, be performed within the quoted tooling capacity requirements?

Yes _____ No _____ Comments: ____________________________________________________________

________________________________________________________________________________________

4. Does the net through-put of good pieces (scrap taken out, any allowable rework) meet daily quoted capacity?

Yes _____ No _____ Comments: ____________________________________________________________

________________________________________________________________________________________

5. Is the acceleration plan sufficient to meet requirements? Yes _____ No _____

Comments: ______________________________________________________________________________

________________________________________________________________________________________

Note: All of the preceding five requirements must be met to pass the Run @ Rate.

D. PART QUALITY PLAN TO ACTUAL

1. Are all Production checking fixtures complete, with acceptable measurement system studies (i.e., gage R and R) performed, and operator instructions/visual aids available? Yes _____ No _____

Comments: ______________________________________________________________________________

________________________________________________________________________________________

2. Are all in process gaging and controls complete, functional and in place? Yes _____ No _____

Comments: ______________________________________________________________________________

________________________________________________________________________________________

3. Do the process control plans (normal and GP-12) agree with the actual process? Do production part checks and statistical monitoring take place as outlined on the process control plan?

Yes _____ No _____ Comments: ____________________________________________________________

________________________________________________________________________________________

1960

RUN @ RATE GP-9 -- RUN @ RATE WORKSHEET

ATTACHMENT B

Supplier Name: __________________________________ Part Number(s): _____________________________

D. PART QUALITY PLAN TO ACTUAL (CONTINUED)

4. Are potential failure modes, as identified in the PFMEA, addressed through error-proofing or the control plan? Yes _____No _____ Comments: ______________________________________

____________________________________________________________________________

5. Do the process control plan reaction plan and the supplier's corrective actions ensure effective containment and correction? Yes _____No _____ Comments:__________________________

____________________________________________________________________________

Note: All of the preceding five requirements must be met to pass the Run @ Rate.

E. PART QUALITY RESULTS:

Note: The total number of parts produced, the pieces rejected and the pieces reworked must be documented on the summary sheet.

1. Do the parts produced off production tooling during the Run @ Rate meet GM's requirements for

on-going quality, as stated in PPAP? Yes _____No _____ Comments: _____________________

______________________________________________________________________________

2. Is the manufacturing process in control? Yes _____No _____ Comments: ___________________

______________________________________________________________________________

3. Does the manufacturing process demonstrate the required capability? Yes _____No _____

Comments: _____________________________________________________________________

_______________________________________________________________________________

4. Is the process control plan sufficient to effectively meet the design record requirements, i.e., control points, frequency of checks, etc.? Yes _____No _____ Comments: _________________________

_______________________________________________________________________________

5. Nonconformances

a) Were the non-conformances yielded by the process identified by the normal PPAP control plan?

Yes _____ No _____ If identified by the GP-12 Process Control Plan or an activity outside documented plans, corrective action is required.

b) Did the PFMEA identify the potential failure modes? Yes _____ No _____ If not, the PFMEA needs to be updated and corrective action put in place.

c) Do all the observed rework and repairs effectively correct the nonconformance(s)?

Yes _____ No _____

d) Are there any open concerns from prototype or pilot (PR/R)? Yes _____ No _____

Comments: _________________________________________________________________

___________________________________________________________________________

Note: All of the preceding requirements must be met to pass the Run @ Rate.

Attachment B to GM-1960 GM-1965 (2/95)

RUN @ RATE GP-9 -- RUN @ RATE WORKSHEET

ATTACHMENT B

Supplier Name: _______________________________ Part Number(s): ____________________________

F. SUBCONTRACTOR REQUIREMENTS

1. Were subcontractors' abilities to meet the customer's quality and capacity requirements confirmed by the supplier prior to the Run @ Rate being conducted at the supplier's facility? Was verification

of the subcontractors' manufacturing processes accomplished through a Run @ Rate or similar process conducted by the supplier?

Yes _____No _____ Comments: ____________________________________________________

_______________________________________________________________________________

2. Are Controls in place to isolate incoming material until it has been approved?

Yes _____No _____ Comments: ____________________________________________________

_______________________________________________________________________________

Note: The two preceding requirements must be met to pass the Run @ Rate.

G. PACKAGING AND HANDLING

1. During the review of in process and final shipment packaging for preservation of part quality and ease of use by supplier's operators loading and unloading parts, were any problems identified?

Yes _____No _____ Comments: ____________________________________________________

_______________________________________________________________________________

2. Does the supplier's method for in process and final shipping packaging and handling effectively eliminate the potential for process errors or mixed stock? Yes _____No _____

Comments: _____________________________________________________________________

_______________________________________________________________________________

COMMENTS:

_______________________________________________________________________________

_______________________________________________________________________________

_______________________________________________________________________________

_______________________________________________________________________________

_______________________________________________________________________________

_______________________________________________________________________________

_______________________________________________________________________________

_______________________________________________________________________________

_______________________________________________________________________________

_______________________________________________________________________________

_______________________________________________________________________________

_______________________________________________________________________________

_______________________________________________________________________________

_______________________________________________________________________________

Completed by: ______________________________ Phone: ____________________ Date: ____________

1960

-----------------------

GENERAL PROCEDURE

GENERAL MOTORS SUPPLIER DEVELOPMENT

GENERAL PROCEDURE

GENERAL MOTORS SUPPLIER DEVELOPMENT

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download