Change Control

 

CHANGE CONTROL DOCUMENTS & DATA (4.2.3) Updated customer print or specification Product information documents Quality manual & policies Procedures & Forms Work instructions Change Request form Deviation Request form

INPUT Customer  Need to have speci fication and/or prin t changes implemen ted Internal Need to control changes to processes and documentation

PROCESS

Receive external change notification

 _ Proper revision, available as needed

Identify internal need for change

S, CS, PM

RECORDS (4.2.4) Obsolete docu ments (previou s rev. rev. on ly) Approved Change Request forms

IP

- Legib le, retrievable, retrievable, protected

Document change request S, CS, PM, IP

Submit for review to affected function(s)

Modify c hange request request

S, CS, PM, IP, AM

Is change acceptable & feasible?

NO AM

AM

MODIFY

Reject or  modify the request?

AM

YES

REJECT

Approve change change request & submit for implementation

Notify requestor of  change rejection

PERSONNEL (6.2) Sales (S) Customer Service (CS) Affected area manag ers (AM) (AM) Quality manag er (QM) (QM) Purchasing Manager (PM) (PM) All internal personnel(IP) personnel(IP) Quality Plan ning Team (QPT)  _ Verified quali fications fications & training

EQUIPMENT (6.3)

AM

Change documentation only?

S, CS, AM

NO

S, CS, AM, QM YES

Modify affected documents & release release new version( s)

Obtain c hange appro approvals vals from customer if required S, CS, QM

Initiate & obtain deviation app approval rovals s internall internally y and /or  from customer if necessary

Computer system Office Office software TMM database CAD system  _ Verified suitability & maintenance

ENVIRONMENT (6.4) Office Office are a Designated record storage areas  _ Safe, clean, suitable

AM, QM

QM

Retain copy of previous doc. version for reference QM

Implement & review changes with affected personnel

Modify, verify and validate existing processes processes , materials mater ials , methods methods , equipmentt , controls and equipmen documentation

MATERIALS (7.5.3, 7.5.5) Office supplies  _ Properly han dled dled,, stored, preserved

QPT

GAUGES (7.6) N/A

QM, AM

INSPECTION & MONITORING Process (8.2.3): Internal audit results

OUTPUT Customer  Specificatio n and/or print change s are i mplemented. Internal Changes to processes and documentation are controlled and records are retained .

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Product (8.2.4): N/A  _ Adequate, agree w/ plans

Rev. 10/21/09