QMP 6.3 Planning of Changes

1.0            Purpose

The purpose of the Planning of Changes procedure is to ensure that changes to the Quality Management System are carried out in a planned manner.

2.0            Scope

This procedure applies to QMS changes that could conceivably affect the integrity of the QMS, the availability of resources, require the reallocation of responsibilities and authorities or have potential unintended consequences.

3.0            Applicable Documents

3.1               Management Review - MOP #1

3.2               Continuous Improvement Projects Tracker

3.3               Corrective Action - JDM200

3.4               Process Change Form (PCF) - JDM-F-200

3.5               New Supplier Evaluation & Approval - QMP 8.4

4.0            Responsibility

4.1    All employees who initiate changes shall be responsible for recognizing changes and obtaining authorization before making the changes.

5.0            Definitions

5.1    Change - A modification to equipment, procedures, raw materials or providers of services or process parameters outside of the original plan which substantively changes or potentially substantively changes intended outcomes. These types of changes can change operating and/or maintenance procedures or requires operation outside of established operating limits.

5.2    Emergency Change - Any change (as noted above in 5.1) that would result in unreasonable risk to personnel, the environment, equipment or significant production loss while waiting for the Normal process change approval process.

5.3    Process Change Form - A form used to evaluate any substantive or potentially substantive process change.

5.4    Appropriate Approver - Appropriate approvers are personnel in certain positions authorized to approve the Process Change Form and initial change. These positions are listed below:

            Heads of Operations (Exec VP, VP, Directors of Opns, Plant Managers), Heads of Quality (SR VP Quality, Quality Managers)

6.0            Application

6.1        A PCF will be prepared for any change, meeting the criteria in 5.1 above, that is not a repair. 

6.2        The initiator fills out the PCF and attaches appropriate supporting documentation, such as drawings, specifications, etc. 

6.3        The completed PCF is circulated for approval(s) to designated approvers. If the PCF is not approved, the PCF is returned to the initiator with the reason for disapproval.

6.4        If the PCF is approved, the approver signs and dates the PCF and it is provided to Quality for concurrence and storage of records. 

6.5        Temporary Changes  - For temporary changes, the procedures is the same as steps 5.1-5.4, except that the following additional steps are taken:

6.5.1    The initiator of the change should indicate that the change is Temporary, and write in the date and person responsible for removing the change.

6.5.2       To change a temporary change to a permanent change, a new PCF must be initiated.

7.0            Emergency Change Procedure

7.1        The initiator of the Emergency Change should complete the PCF Form directly after the emergency change has been completed and indicate the type of change as Emergency.

8.0            Pre-Startup Review

8.1    Ensure process activities, including inputs and outputs, are verified and validated. 

8.2        Types of procedures or documentation that may be affected:

            Work Instructions, Measurement Methodology, Measurement Frequency, PPAP, Process Flows, Control Plan, PFMEA, Emergency or Safety Procedures

9.0            Facility Change Communication/Training

9.1           All employees and those customers requiring change notification that are affected by a Change must be informed of the Change.

9.2           Introduction of new processes will typically require formal training sessions to all affected personnel.

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