SAH Change Control Form

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Complete the form for any change to Product by the supplier, material or process related to the QMS, Organisation or staff, the improvement or correction of the QMS, Infrastructure/ Environment or any other change that affects the QMS or regulatory compliance

Date *

YYYY

Your name (Authority assigned to approve change) (Initial contact maybe by email or phone)

Change Description

Change to

Product

Material

Process

Method

Staff

Other:

Clear selection

Details of change

Change recommendation

Risk assessment (RA)

The Processes are evaluated using the following table where the justification for determining a risk Aspect as Low, medium or High, for the Probability and Severity. HIGH has a high negative impact on product safety & performance or the effectiveness of the QMS and CONSEQUENTIAL Action is required, MED is that the Risk can be tolerated and must be monitored and LOW is that it is insignificant and no controls required ; RECORD below the name of the person doing the RA

List RISKS under option and label: Probability LMH (add Other if none and justify)

LOW

MEDIUM

HIGH

Other:

Clear selection

Reason for Probability selection

List RISKS under option and label: Severity LMH (add Other if none and justify)

LOW

MEDIUM

HIGH

Other:

Clear selection

Reason for Severity selection

Risk Evaluation

Overall Risk is LOW for Low:Low and Medium:Low or Low:Medium and the Aspect requires no further Action- ALAP (As low as possible)MEDIUM for Medium:Medium and the Aspect must be monitored HIGH for High:High and Medium:High or High:Medium must provide a control measure

Overall Risk

Low

Medium

High

Other:

Consequences (provide other details)

Product Risk Assessment review

Quality Risk Assessment review

Medical Device File update or change

Quality Management System change e.g. Process or Procedure change

Regulatory Documentation update / inform the regulator

Customer advisory notice / customer to be informed

Labelling / IFU change

Other:

For corrective action if required

Follow the SOP Non Conformance Corrective Action - detail the reason for the corrective action requirement

Corrective Action

Yes

Other:

Clear selection

Mitigating Action/ Action Plan (Person Responsible + deadline date) - go to SHEET (Response) to add further details

Submit

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