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Change Control Process Guide

This document outlines a change control process that involves receiving change requests, documenting the requests, reviewing and approving or rejecting the requests, modifying documentation and processes as needed, implementing approved changes, and retaining records. Key steps include identifying the need for a change, submitting the request for review, approving or rejecting the request, modifying documentation and processes, implementing changes, and retaining records and previous versions of documents. The goal is to properly control changes to customer specifications, prints, internal processes and documentation.

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522 views1 page

Change Control Process Guide

This document outlines a change control process that involves receiving change requests, documenting the requests, reviewing and approving or rejecting the requests, modifying documentation and processes as needed, implementing approved changes, and retaining records. Key steps include identifying the need for a change, submitting the request for review, approving or rejecting the request, modifying documentation and processes, implementing changes, and retaining records and previous versions of documents. The goal is to properly control changes to customer specifications, prints, internal processes and documentation.

Uploaded by

hinckdogg
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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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

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