CAPA Sufficiency Review
Is the closure reasoning on this CAPA sufficient to stand on its own?
Test whether the evidence and reasoning behind a CAPA closure support the decision to close it.
You finish with A brief, an exposure list and next actions.
Purchases are final unless a file cannot be delivered or opened, in which case we replace it or refund the price. See Terms, Section 3B.
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Fictional example
“CAPA closed. No recurrence in 90 days.”
What measure and what criterion defined effective? The closure note states neither.
Fictional example
“CAPA closed. No recurrence in 90 days.”
What measure and what criterion defined effective? The closure note states neither.
A record can say one thing and leave one question open.
Challenge the closure against ten questions and nine elements of evidence, then write it as a chain from problem to result.
This example is fictional. It shows where to look. It does not decide whether a decision was acceptable.
Inside the workbook
Four pages from the fillable PDF, exactly as you receive it. Choose a page to read it here. Nothing on this page replaces the PDF.
Response template
Put one decision through it.
Choose one decision you need to be able to explain, then examine what its records support.
- Bring one decision and its records.The CAPA record, the evidence behind the closure, and the effectiveness check.
- Answer from the record, not from memory.If you cannot point to where an answer is written down, it is not in the record yet. That is the finding.
- Bring it together in the brief.The questions most likely to be challenged, the exposure that remains, and your recorded conclusion and next actions.
Leave with a clearer view of what your record can support.
A brief, an exposure list and next actions.
- Where the record answers. The answers you can point to, with the record behind each.
- Where it does not. The exposure that remains, set out so it can be repaired or escalated.
- What to do next. Your recorded conclusion and next actions.
Choose the decision you want to examine.
Use the CAPA Sufficiency Review to connect your answers to the records, and to see which questions remain.
A structured review of your own records. It is not a compliance determination, and it does not predict inspection outcomes.
$39 · Fillable PDF · Delivered by private link to your email. Purchases are final unless a file cannot be delivered or opened, in which case we replace it or refund the price. See Terms, Section 3B.
Product details
What is included
- The 10-Question Review and a nine-element evidence challenge, scored against your own record
- A closure rationale written as a chain from problem to result
- The questions you would face if the CAPA recurred, with a place to answer each
- A brief, an exposure list and next actions, in a 17-page fillable PDF
Who should use it, and who does what
- A CAPA is about to be closed and you want to test whether the closure reasoning stands on its own.
- A CAPA recurred, or could, and you need to show why the earlier closure was reasonable.
- An effectiveness check is open and nobody has written down what it was meant to prove.
The executive
Reads the first page and the results: the readiness count, the exposure and the next actions. Decides on anything marked for escalation.
The decision owner
Completes the rest from the record. Brings: the CAPA record, the evidence behind the closure, and the effectiveness check.
When the tool is complete, the Readout turns the counts into one page the executive can read at a glance.
The four lenses it leans on
Each tool tests a decision against the evidence, judgment, risk and authorization behind it. The markers show which ones this tool leans on most.
- Evidencesecondary
- Judgmentprimary
- Riskprimary
Where it stops
- It tests the reasoning in your record against the questions an investigator asks. It does not judge whether the corrective action was the right one.
- It does not decide for you, and it does not state that a decision is compliant or ready for inspection.
- It is a fillable PDF you complete from your own records. Every worked example in it uses a fictional decision and says so.
- It is not legal or regulatory advice.
Other tools
If a check shows a gap, the next step is the record itself. See the Inspection Response Record.