Change controls

A change control records a requested change to a process, specification, supplier, equipment, facility or document. QA Manager can record a change number, title, description, requester, request date, target implementation date and impact assessment. A product or supplier reference identifies the affected master record when applicable. The filing requirement gives the team a separate place to mark Yes, No or Tbd. It should be reviewed alongside the impact decision.

The change status moves from Draft through under review and pending approval to Approved or Rejected. Approved work can then be marked Implemented and Closed. These are distinct steps. Approval records a decision on the proposed change; implementation records that the change happened. A target date is a planning aid, while the current status tells the team where the record actually stands.

• Request. Capture the change type, affected product or supplier and the reason for the request.
• Assessment. Decide whether the impact is No Impact, Minor, Major or Regulatory and record filing relevance.
• Decision and follow-through. QA Manager approves or rejects the request, then follows an approved item through implementation and close.

Agree who may request each kind of change and which evidence must be present before the status becomes pending approval. Settle who owns the impact assessment and who may approve. QA Manager owns the decision; agree who holds that responsibility and check access during setup. A supplier change should identify the supplier; a product change should identify the product when those references apply.

The team should agree how it identifies open changes that matter to a batch under review. A related product or supplier record provides context, but the release reviewer still needs to inspect the actual change and decide whether it affects the lot. Do not infer that every approved change is already implemented.

A supplier change is requested for a product. Supplier Manager checks the supplier qualification record. QA Manager creates a change control with type Supplier, references the supplier and product, records the requested date and assigns an impact assessment of Major. The manager marks the item under review while collecting the rationale, then pending approval for the decision. If approved, the change proceeds to Implemented and finally Closed. If rejected, the record retains the rejected status and the reason remains in its description.

Before reviewing a batch associated with the product, QA Manager checks whether that change is still pending, approved or implemented. The release decision remains its own record; the change record explains the controlled change and its status.

• Change approval inbox — Changes awaiting the quality approval decision.
• Supplier qualification review — Supplier status and audit timing to consider for supplier changes.
• Batches awaiting quality review — Lots where an affected product may need a closer look.

See change assessment for request and approval and release review for the batch decision.