How to Write a Commissioning and Qualification Plan

A Commissioning and Qualification (C&Q) plan defines how a project will verify that facilities, utilities, and equipment are installed and operate as intended, and are qualified for GxP use. Modern C&Q is risk-based (ASTM E2500): commissioning verifies engineering aspects, and qualification focuses on the aspects critical to product quality and patient safety.

1. 1

   Define scope and the C&Q strategy

   State which systems and areas the plan covers, where their boundaries fall, and the strategy that will be used to verify them. The strategy is the part that has to be decided rather than described: whether commissioning evidence will be leveraged into qualification, to what documentation standard it must therefore be generated, and who is accountable for each stage. Decided after testing has begun, none of it can be applied retrospectively.

2. 2

   Identify critical aspects via system impact / risk assessment

   Identify the aspects of each system that actually affect product quality, through a system impact or risk assessment, and record the reasoning rather than the classification. The output that matters is an argument a reviewer could disagree with — these functions, these parameters, these materials, for these reasons — because that argument is what justifies testing some things deeply and others not at all. A classification produced from a category list is a labelling exercise wearing the same name.

3. 3

   Define the verification approach

   Define how each critical aspect will be verified and by what evidence: engineering testing, commissioning records, supplier documentation leveraged with its rationale, or qualification protocol. Say what acceptance looks like in each case. The common gap is a plan that names the stages but never says which stage verifies which aspect, so the trace has to be assembled at the end, by which point the gaps are expensive.

4. 4

   Assign roles and documentation

   Assign who writes, who executes, who witnesses, who reviews and who approves at each stage, and state the documentation standard each record must meet. Where commissioning records are intended to be leveraged, that standard is the whole mechanism — records written as working notes cannot become evidence later, and discovering this after execution means repeating the test.

5. 5

   Define handover and acceptance

   Define what handover requires and what acceptance means: the condition the system must be in, the package that accompanies it, the punch items that may and may not remain open, and who accepts on behalf of the receiving organisation. Qualification begun on a system still carrying open critical items verifies a system that is not in its intended state, and the plan is where that sequence is made explicit rather than assumed.