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CHANGE NOTE (CN) CN:

FRM-012
Parent Procedure SYS-006
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SECTION A  CHANGE PROPOSAL

Name of person proposing change: Date:

Product: Process:

Source of change proposal: Reference to e.g. improvement initiative; CAPA; customer meeting minutes,
Design Review or other product development activities.
Type of Change (may be more than one):
Document Process/Engineering Labeling Supplier
Design Testing Equipment Material
Other (describe briefly) <Description>
Background to Change:
Intended outcome and rationale for change.
Proposed Change:
Summary of change, sufficient for someone else to be able to approve the proposal. Include when and
how the change will be implemented. It is not necessary to spell out all the detail that is in the Change
Plan or will be in the documentation.. It may be appropriate to include an analysis of costs.
Risk Management: Refer to the attached FMEA for an assessment of risks that could be introduced by
this change and the control methods that will be used to reduce those risks.
Use the design requirements matrix (FRM-019) to document risk analysis and design changes.

Change Plan

1. Customer Pre-approval or Notification:

Is pre-approval or notification required? By which customers? When? By whom?
2. Supplier Notification:
Does a contract designer or manufacturer, or other supplier, need to be consulted as part of development
of the change plan, or notified of the change? When? By whom?
Affected suppliers must be notified of the change implementation point and applicability to any current
orders.
Confirmation of receipt of the revised specifications, and acceptance that they can comply, should be
confirmed by the supplier by email and recorded on the CN with a copy of the email attached.

3. Documents to be released:
Code Title New or Revn? Person

4. Training required (particular to change implementation, extra to that required as part of Document Release):
Use FRM-002 Training Record to record this training, putting the CN number in the header of the training
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Parent Procedure SYS-006
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record as the “Main Document”

Topic Who to train Trainer

5. Stock disposition:
If a material change, is existing stock to be run out, used elsewhere or disposed of?
6. Supplier change:
If a material or process is being moved to another supplier, is that supplier approved to supply that
product or process? Is qualification required?
7. Qualification and Validation:
Is new equipment being introduced or existing equipment moved or altered, requiring IQ?
Is this a process change which requires OQ and PQ?
8.Regulatory Approvals
What impact does the proposed change have on regulatory approvals? Is it necessary to notify authorities?
Does a rationale (for the file) need to be prepared for not notifying?
9. Add other items specific to this change.
10. Monitoring and Assessment:
How will you know whether an improvement has been achieved, goals met, the change successful?
Who will be responsible for monitoring?
For how long/how many batches should assessment continue?
By what criteria will you judge whether the change has been effective?
Does extra information need to be collected or testing performed in order to assess effectiveness?
Are there any trigger points which would result in immediate action rather than waiting to the end of the
assessment period?

Change Proposal Approval

Position Name Signature & Date

Quality Manager
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FRM-012
Parent Procedure SYS-006
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SECTION B  CHANGE IMPLEMENTATION

First batch after change implemented:

Implementation Of Change Plan

Adjust this table to match the approved plan then print the page.

Plan Step Reference Initials Date

1. Customer communication
2. Document release
3. Training
4. Stock disposition
5. Supplier change
6. Qualification and Validation
7. Regulatory Approvals
8. Monitoring and Assessment
9.

Comments:
This section hand-written as the change progresses.

If the plan is not implemented as described in Section A, explain here, using the same numbering, e.g. (2)
to describe a deviation from the plan for training.

Give references to be able to trace to any documents that were generated but are not referenced in the
plan.

Any other comments that would be useful when referring back to this CN.

Change Implementation Closure (verification that the change plan has been fully & correctly implemented).
name and signature
Verified by Change Date:
Controller:
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SECTION C  MONITORING OF CHANGE

Results:
Enter or summarise data here (or refer to a TR). Compare results with acceptability criteria.

Analysis and Conclusion:

Draw a conclusion as to whether the change was effective in achieving its goals or otherwise. Neutral is
also acceptable, i.e. no improvement achieved, but nothing is worse.
If a conclusion can be reached, then usually monitoring ceases and the CN is closed.
If a conclusion cannot be reached because the data does not support a conclusion, then monitoring may
continue, and the method of monitoring may change. Create a new Monitoring page. This should not
happen often.
If the result is negative, i.e. results are worse than prior to the change, then a decision must be made
without delay as to how to proceed. Investigation may be required and it is likely that another CN will be
required to reverse out the change or to implement another change. Close out this CN as soon as
monitoring results are in and the conclusion is reached.

Closure

Closed in Register: Date:

End of document