Deviation Decision Check
Why was this deviation considered adequately resolved?
Check the reasoning behind a deviation disposition before it is questioned.
You finish with A brief, a readiness count 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
“Classified minor. No product impact.”
The criteria, and who applied them, are not recorded. The impact that was considered is not stated.
Fictional example
“Classified minor. No product impact.”
The criteria, and who applied them, are not recorded. The impact that was considered is not stated.
A record can say one thing and leave one question open.
Take the deviation from detection to closure, and test the path from cause to disposition.
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 deviation record, the impact assessment, and the closure decision.
- 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, a readiness count 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 Deviation Decision Check 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 records behind the deviation, and twelve questions on the closure
- A timeline from detection to closure, and the path from cause to disposition
- The questions you would face if the deviation recurred
- A brief, a readiness count and next actions, in an 18-page fillable PDF
Who should use it, and who does what
- A deviation is about to be closed and you want the impact assessment and the decision to close connected on paper.
- A deviation recurred and you need to show why the earlier disposition was reasonable.
- You inherited a deviation file and cannot tell why it was closed.
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 deviation record, the impact assessment, and the closure decision.
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.
- Evidenceprimary
- Judgmentprimary
- Risksecondary
Where it stops
- It tests the reasoning that links impact to closure. It does not classify the deviation or replace the investigation.
- 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.