CHANGE CONTROL

INPUT Customer Need to have specification and print changes implemented /or Internal Need to control changes to processes and documentation 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 _ Proper revision, available as needed

PROCESS

Receive external change notification

S, CS, PM

Identify internal need for change

IP

RECORDS (4.2.4) Obsolete documents (previous rev only) . Approved Change Request forms - Legible retrievable, protected ,

Document change request

S, CS, PM, IP

Submit for review to affected function(s)

S, CS, PM, IP, AM

Modify change request

MODIFY AM

Is change acceptable & feasible?

YES

NO AM

Reject or modify the request ?

REJECT

PERSONNEL (6.2) Sales (S) Customer Service (CS) Affected area managers (AM) Quality manager (QM) Purchasing Manager(PM) All internal personnel(IP) Quality Planning Team (QPT) _ Verified qualifications& training

AM

Approve change request & submit for implementation

AM

Notify requestor of change rejection

S, CS, AM

EQUIPMENT (6.3) Computer system Office software TMM database CAD system _ Verified suitability & maintenance

Change documentation only?

S, CS, AM, QM YES

NO

Obtain change approvals from customer if required

S, CS, QM

Modify affected documents & release new version (s)

QM

Initiate & obtain deviation approvals internally and /or from customer if necessary
AM, QM

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

Retain copy of previous doc . version for reference

QM

Modify, verify and validate existing processes , materials , methods , equipment , controls and documentation
QPT

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

Implement & review changes with affected personnel

QM, AM

GAUGES (7.6) N/A

OUTPUT Customer Specification and/or print changes are implemented . Internal Changes to processes and documentation are controlled and records are retained .

INSPECTION & MONITORING Process (8.2.3): Internal audit results Product (8.2.4): N/A _ Adequate, agree w/ plans

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Rev. 10/21/09