Professional Documents
Culture Documents
10 - Managing Changex
10 - Managing Changex
10 - Managing Changex
0 – Managing
Change
10.1) Benefits
PPCR’s are required for any hardware or software changes that may
effect the following:
• Final Piece Cost or Quality
• Machine / System Reliability
• Job Instructions / Working or Gageing Instruction / Control Plan /
PFMEA / Process Flow Chart..
• Training Material
• Maintenance Procedures
ENVIRONMENTAL ENGINEERING: FOR QUESTIONS ON ASSESSING ENVIRONMENTAL IMPACT, CONTACT ENVIRONMENTAL ENGINEER.
QUALITY / RELIABILITY:
P PRODUCTION FOLLOWING ANY CHANGE IN PROCESS OR METHOD OF MANUFACTURE. SECTION 4: OTHER INSTRUCTIONS / COMMENTS
P CORRECTION OF A DISCREPANCY ON A PREVIOUSLY SUBMITTED PART.
P PRODUCTION FROM TOOLING AND EQUIPMENT TRANSFERRED TO A DIFFERENT PLANT LOCATION OR FROM AN ADDITIONAL PLANT LOCATION.
P PRODUCTION FOLLOWING REFURBISHMENT OR REARRANGEMENT OF EXISTING TOOLING OR EQUIPMENT.
SECTION 5A: TO IMPLEMENT PPAP WARRANT APPROVED (IF APPLIC.)
P CHANGE IN SOURCE FOR SUBCONTRACTED PARTS, MATERIALS, DUNNAGE OR SERVICES (e.g. HEAT-TREATING, PLATING, PAINTING, ETC.)
THIS AREA IS FOR USE BY CHANGE LEADER'S SUPERVISOR ONLY
P PRODUCT RE-RELEASED AFTER TOOLING HAS BEEN INACTIVE FOR VOLUME PRODUCTION FOR TWELVE MONTHS OR MORE. APPROVED BY: PRINT NAME SIGN DATE
(LEADER'S GENERAL SUPERVISOR OR SUPERINTENDENT)
P FOLLOWING A CUSTOMER REQUEST TO SUSPEND SHIPMENT DUE TO A SUPPLIER QUALITY CONCERN.
THIS AREA IS FOR CUSTOMER (MANUFACTURING) USE ONLY
P PRODUCTION FROM NEW OR MODIFIED TOOLS (EXCEPT PERISHABLE TOOLS), DIES, MOLDS, PATTERNS ... ETC.,
APPROVED BY: PRINT NAME SIGN DATE
INCLUDING ADDITIONAL OR REPLACEMENT TOOLING. (MANUFACTURING GENERAL SUPERVISOR OR SUPERINTENDENT)
CMP
4 4A 4B 4B. HAS THE PDT/CIT APPROVED OR REJECTED THE CHANGE?
PPCR APPROVED 4C. THE PDT/CIT LEADER NOTIFIES THE CHANGE LEADER OF APPROVAL OR
REJECTION.
APPROVED
6A. IF ANY SIGNATURE CANNOT BE OBTAINED, THE CHANGE PROCESS STOPS. ALL OTHER
DEPARTMENTS CONTACTED IN SECTION 3 OF PPCR FORM.XLS MUST BE NOTIFIED OF THE
8. DOES THE CHANGE LEADER ACQUIRE WRITTEN DIRECTION TO PROCEED WITH CHANGE
STOP
(OTHER INSTRUCTIONS, SECTION 4 PPCRLOG.XLS) FROM HIS/HER GENERAL SUPERVISOR OR
8 8A SUPERINTENDENT, ALONG WITH SIGNATURE (SIGNATURE BLOCK, SECTION 5A OF PPCR FORM)?
8A. IF DIRECTED TO NOT PROCEED, STOP. NOTIFY ALL CONCERNED PARTIES (SECTION 3 OF PPCR
PROCEED FORM.XLS) WITH REASON FOR CHANGE REJECTION.
9 9. CHANGE LEADER, ALONG WITH THE PARTIES NAMED IN SECTION 3 OF PPCR FORM.XLS,
IMPLEMENTS PROCESS CHANGE
10. CHANGE LEADER RECORDS THE DATE THE PROCESS CHANGE WAS IMPLEMENTED ON THE
10 PPCR FORM (PPCR FORM.XLS) AND ON THE PPCR LOG SHEET (PPCRLOG.XLS, SEE SECTION 5B).
11. CHANGE LEADER ATTACHES APPLICABLE WORK SHEETS AND FORWARDS COMPLETED PPCR
11 FORM TO GENERAL SUPERVISOR OR SUPERINTENDENT FOR FINAL APPROVAL. SECTION 5B
(PPCRLOG.XLS)
12 12. CHANGE LEADER GIVES ORIGINAL COPY OF FINAL APPROVED PPCR TO MFG ENGINEERING
CLERK.
1) For any product/process/source change, a feasibility analysis is carried out. The study - an example of modification
takes into account the impacts in terms of costs/technical/performance/ - a feasibility analysis including lead time analysis
quality/timing/capacity - formalized impact evaluation & risk management
A risks analysis is applied for any 2) Potential risks of change are considered via FMEA approach and document in DFMEA - PFMEA
MC2 X X X product/process change. and PFMEA - DFMEA
3) Based on risk analysis planning and implementation of the change are carried out, a
product/process validation plan is defined
4) According to risk analysis, a securing approach is put in work in the launch phase
1) A standardized communication procedure and form to control and monitor all - existing procedure
Production Trial Runs that documents each step of the process & records all approvals - example of trial run
and results. - trial run form
Established procedure for Production Trial Run
MC3 X (PTR) process.
2) Tracebility of trial run batch - trial run validation criteria & results (records)
3) Quality reviews documented to release product for PTR shipment and verification
process has returned to normal production.
1) At planning phase, banking strategy takes account of process capacity, customer - example of modification
need, leadtime of change and safety margin. If needed Customer approval for safety stock - banking planning and follow-up
level - evidence of reviews
2) Stock level has to be managed in real time at phases of build up and implementation of - follow up of stock level
change. In case of deviation custormer should be alerted. - long term storage specific measures inc packaging
A parts banking strategy/procedure for long term 3) Established guidelines for execution of long term storage including protective packaging - FIFO respect
MC4 X storage of parts or materials for parts and material.
4) Quality reviews to established inspection criteria for the authorized release of banked
parts and material prior t internal usage or shipment
5) Except special agreements with customer, the supplier guarantees the complete
exhaustion of the products to the old change level before delivering new change level,
FIFO is kept
1) During planning phase alternative processes have to be identified and minimum most - is there a specific procedure
critical ones to be considered as part of approved process - examine situation of botteneck operations, equipments assiocated
2) Alternative processes have to be handled like any of normal process risk of capacity
3) When alternative process is used, process should be temporaly and return to normal - example of by-pass process
Alternative processes are defined and process as soon as possible
MC5 X X X managed. A procedure is in place to authorize 4) By-pass process approved by Operations, Engineering and Quality manager,
bypassing processes Standardized Work and training applied
5) When alternative or by-pass process is used tracebility has to be ensured.
6) Specific countermeasures (ex: quality wall ) and audit are in place when alternative or
by-pass process are running
This document is a
record that documents:
• breakpoints of
entering and exiting
the by-pass process
•identifies tooling,
inspection, and
audit
requirements