Writing Work Instructions

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:Work Instruction
Description: Supplier Process Change Request
Revision Date: 5-24-10
Date Issued: 5-24-10
WI# 7410-000-006-0 COR
Page 1 of 8
Written By:
Jim Bonner
Approved By:
Prasenjit Adhikari
1. PURPOSE
This document defines the PCR (Process Change Request) process for Suppliers to MAYSTEEL LLC.
The PCR process controls changes to MAYSTEEL LLC products, supplier materials or processes. The PCR
review process is designed to evaluate proposed changes while providing an assessment of risk to product
reliability and compatibility with other manufacturing processes. Changes implemented without PCR notification
and approval may generate non-compliant product material(s) rejectable by MAYSTEEL LLC.
2. SCOPE
2.1 The PCR procedure applies to suppliers of component parts and partial or finished
assemblies used to produce MAYSTEEL LLC products whether supplied to MAYSTEEL LLC or to a
MAYSTEEL LLC Subcontractor.
2.2 The PCR procedure applies to all MAYSTEEL LLC product components and finished assemblies unless
specifically waived by MAYSTEEL LLC. Lack of a waiver shall default to the requirements of this
specification.
2.3 The PCR process does not apply to materials, services or finished products purchased by MAYSTEEL LLC but not
directly used to manufacture or deliver MAYSTEEL LLC products unless so designated in the related purchase
documents.
3. DEFINITIONS
3.1 PRC: Change to a process as identified in this work instruction
3.2 PCR Change Request Form: document used to request and detail the change to process
3.3 POR: Supplier Process Of Record, documentation provided by the supplier that identifies
in detail the manufacturing process used for parts, assemblies and finished goods supplied to
MAYSTEEL LLC.
4. FORMS
The following documents are referenced in this specification;
4.1 MAYSTEEL LLC ECN Work Instruction
4.2 Part or Product specific requirements specifications
4.3 ASL Approved Supplier List (MAYSTEEL LLC confidential)
4.4 MAYSTEEL LLC SPOC manual
4.5 Process Change Request Form
5. INPUTS
5.1
5.2
5.3
5.4
Process Change Request from a supplier
Process Of Record for Supplier
MAYSTEEL LLC specifications and documentation
MAYSTEEL LLC customer specifications and documentation
6. SCHEMATIC OVERVIEW:
Diagram of PCR operational flow.
:Work Instruction
Description: Supplier Process Change Request
Revision Date: 5-24-10
Date Issued: 5-24-10
WI# 7410-000-006-0 COR
Page 2 of 8
Written By:
Jim Bonner
Approved By:
Prasenjit Adhikari
Fig 1: Schematic of PCR process flow
Mfgr wants to
request a change
in manufacturing
process or specs
Mfgr prepares a PCR
request detailing change
Gather requested
non-product data
PCR REQUEST
SUBMITTED TO Maysteel
Quality
Engineering
Review
Engineering
Review
Purchasing
Review
PCR
Acceptable
No
Supplier Mgmt
Review
Need
more data
Yes
No
Maysteel Personnel generate
ERN to implement PCR
PCR Rejected
Notify Submitter
Change Implemented
Notify Submitter and all
other affected Suppliers
Yes
:Work Instruction
Description: Supplier Process Change Request
Revision Date: 5-24-10
Date Issued: 5-24-10
WI# 7410-000-006-0 COR
Page 3 of 8
Written By:
Jim Bonner
Approved By:
Prasenjit Adhikari
7. Procedure
7.1 A PCR form is required to be completed by the responsible Supplier and submitted to MAYSTEEL LLC
for any process, equipment, or material change that has the potential to affect the form, fit, function or
reliability of any MAYSTEEL LLC product. Since not all ultimate product effects are apparent when
evaluating the impacts of a change, it is required to err on the side of caution and notify MAYSTEEL
LLC though the PCR process of all Supplier manufacturing changes.
7.2 A PCR must be sent to MAYSTEEL LLC before implementation of a change. MAYSTEEL LLC will review and
respond as soon as possible.
7.3 Initial Request: The supplier will initiate a PCR request by describing the proposed change, the expected effect and
providing reliability or performance data to support the request. See Appendix A for a PCR request form.
7.4 MAYSTEEL LLC Review: The request will be processed by the appropriate Supply Chain Manager who
will review the PCR request and forward copies to MAYSTEEL LLC Project Engineering, Quality
Engineering, and Purchasing for additional review. All sections will determine the acceptability of the
request. MAYSTEEL LLC may also contact other suppliers of a MAYSTEEL LLC product number that
would be affected by a PCR request for comment.
7.5 Response to PCR: After review, MAYSTEEL LLC will respond to the PCR request as follows;
7.5.1
Accept: The requested change is determined to be acceptable to MAYSTEEL LLC. The
Supply Chain Manager will notify the request initiator and will begin the ERN process if
required to incorporate the change into the necessary product specs or supplier Process of
Record (POR). PCR or ERN approval is required prior to implementation. All suppliers
will be notified of the changed product requirements when the PCR or ERN is complete.
Only the initiator will be notified regarding a PCR change. A phase-in plan may be
developed as necessary.
7.5.2
Reject: MAYSTEEL LLC determines that the request is unacceptable. The Supply Chain
Manger will notify the request initiator of MAYSTEEL LLC decision. MAYSTEEL
LLC may, but is not required to, share the reasons for refusal.
7.5.3
Request more information: MAYSTEEL LLC determines that additional information is
needed to make a decision. The Supply Chain Manager will contact the request initiator
to inform of status and request the desired information or, at MAYSTEEL LLC option,
authorize testing by use of a controlled lot to use the requested change. The initiator may
elect to collect the information and re-submit the PCR request or to cancel the request.
No product or process change is allowed without the completed PCR or ERN
documentation.
7.5.4
Additional Information Only- MAYSTEEL LLC will contact the submitter with a request
for additional information. No product testing is required or authorized.
7.5.5
Additional Information through product testing – will generate a request for suitable test
lot(s) with the requested change to be processed. The request will include PCR data
collection requirements and acceptance criteria. The request will also document the
product acceptance and field release criteria. On successful completion of the request the
PCR will be approved and implemented.
7.5.6
PCR Documentation: Upon accepting a PCR, the Supply Chain Manager will be responsible for
submitting the necessary PCR / ERN requests to implement the requested change.
:Work Instruction
Description: Supplier Process Change Request
Revision Date: 5-24-10
Date Issued: 5-24-10
WI# 7410-000-006-0 COR
Page 4 of 8
Written By:
Jim Bonner
Approved By:
Prasenjit Adhikari
7.5.6.1 Supplier POR – Changes to the supplier’s Process of Record (POR) will be updated
by the Supply Chain manager to reflect the new process. No notification to other
suppliers is allowed.
7.5.7
8
Notification: Upon approval of the PCR implementing an MAYSTEEL LLC product change, all
affected suppliers will be notified of the modified requirements. Approval of a supplier specific
POR change will be communicated only to the initiator.
RESPONSIBILITIES
8.2 Supplier: A supplier to MAYSTEEL LLC or MAYSTEEL LLC sub-contract manufacturers is required to maintain a
controlled, consistent process. The supplier is responsible to notify MAYSTEEL LLC through the PCR process of
process or material changes and to provide supporting data showing yield or reliability improvement.
8.3 MAYSTEEL LLC Supply Chain Manager: To coordinate the PCR review within MAYSTEEL LLC. Responsible
to generate and process any necessary ERN documents to implement a PCR. Responsible to add non-documented
PCR’s to the supplier’s history file.
8.4 MAYSTEEL LLC Purchasing: Responsible to review PCR requests in a timely manner. To notify suppliers of
changed purchase requirements.
8.5 MAYSTEEL LLC Project Engineer: Responsible to review PCR requests in a timely manner. To review PCR
requests for potential issues in hardware/software interactions, product performance or reliability issues.
8.6 MAYSTEEL LLC Quality Engineer: Responsible to review PCR requests in a timely manner. To review PCR
requests for potential issues in manufacturing operations, product performance or reliability issues.
8.7 Other (as necessary): Secondary suppliers responsible to review change requests as potential future requirements
and highlight issues or concerns.
9 OUTPUTS / RECORDS
9.2 Completed and approved PCR Form
9.3 Updated POR for supplier
:Work Instruction
Description: Supplier Process Change Request
Revision Date: 5-24-10
Date Issued: 5-24-10
WI# 7410-000-006-0 COR
Page 5 of 8
Written By:
Jim Bonner
Approved By:
Prasenjit Adhikari
APPENDIX “A” SAMPLE: “PCR PROCESS CHANGE REQUEST FORM”
================================================================
Section 1 (completed by Supplier)
Fabricator: ____________________________________________
Address:
Page: 1 of 3
Date: _____________
_______________________________________
_______________________________________
_______________________________________
_______________________________________
Detailed Description of Proposed Change: _____________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
Reason for Change :_______________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
:Work Instruction
Description: Supplier Process Change Request
Revision Date: 5-24-10
Date Issued: 5-24-10
WI# 7410-000-006-0 COR
Page 6 of 8
Written By:
Jim Bonner
Approved By:
Prasenjit Adhikari
MAYSTEEL LLC Products numbers affected by this PCR:
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
Effect if not implemented : _________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
Evidence supporting change :_______________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
Alternatives ‘:____________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
Page 2 of 2
MAYSTEEL LLC RESPONSE
Section 2 (completed by MAYSTEEL LLC)
ACCEPT / REJECT / MODIFY: ____________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
ERN Required: ______________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
ERN ____________________________________________________________________________________
Product Part Number______________________________________________________________________
Quantity _________________________________________________________________________________
Data Collection____________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
Acceptance Criteria________________________________________________________________________
:Work Instruction
Description: Supplier Process Change Request
Revision Date: 5-24-10
Date Issued: 5-24-10
WI# 7410-000-006-0 COR
Page 7 of 8
Written By:
Jim Bonner
Approved By:
Prasenjit Adhikari
_________________________________________________________________________________________
_________________________________________________________________________________________
Field Release Plan_________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
Request for Additional Information: _________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
Phase in plan (with completion dates): ________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
_________________________________________________________________________________________
PCR Request Form
Page 3/3
PCR REVIEW PARTICIPANTS
___________________________________________
MAYSTEEL LLC Project Eng
____________________
Date
___________________________________________
MAYSTEEL LLC Supply Chain Manager
____________________
Date
___________________________________________
MAYSTEEL LLC Quality Engineer
____________________
Date
:Work Instruction
Description: Supplier Process Change Request
Revision Date: 5-24-10
Date Issued: 5-24-10
WI# 7410-000-006-0 COR
Page 8 of 8
Written By:
Jim Bonner
Approved By:
Prasenjit Adhikari
___________________________________________
MAYSTEEL LLC Purchasing
____________________
Date
___________________________________________
Request Initiator
____________________
Date
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