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CAPA Review Time Slack Tool

Audit supplied CAPA review clocks without asserting regulatory compliance.

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Description

Audit supplied CAPA review clocks without asserting regulatory compliance.

Quality records separate measured results, reference values, acceptance rules, and supporting evidence. Arithmetic consistency and record coverage can be checked against supplied criteria without establishing traceability, approving a method, or deciding product conformity.

Audit supplied CAPA review clocks without asserting regulatory compliance.

When to use this tool

Use it for capa review time slack when the required inputs and conventions are already available.

How to use the tool and how it works

  1. Enter dueAt, reviewedAt, creditedPause. Use the stated units and boundary conventions.
  2. Run the calculation. Correct any input error before interpreting a result.
  3. Read slack. Inspect any known, defined, inclusion, or boundary flags before interpreting numeric values.

Require nonnegative creditedPause and return slack=dueAt-reviewedAt+creditedPause.1

Input fieldMeaning and unitsAccepted input
dueAtDue AtRequired. Finite number.
reviewedAtReviewed AtRequired. Finite number.
creditedPauseCredited PauseRequired. Finite number; minimum 0.
Output fieldInterpretationReturned shape
slackSlackRequired. Finite number.
json
{
  "input": {
    "dueAt": 30,
    "reviewedAt": 25,
    "creditedPause": 2
  },
  "output": {
    "slack": 7
  }
}

Limitations and assumptions

  • Positive slack means review time falls within the supplied paused deadline. Pause is not capped against elapsed time or merged with other pauses; all clock conventions are supplied.
  • The field tables describe structural bounds; the mechanics also state cross-field requirements. Malformed input shapes, disallowed keys, and invalid domains cause input errors. Results must remain finite and within the declared output contract. A successful false flag or zero placeholder is distinct from an error.
  • Numeric arithmetic uses binary floating point. Exact comparisons have no hidden tolerance or decimal rounding; negative zero is exported as zero. Decimal-text integer operations retain the exactness specifically stated above.

Alternative or Complementary methods

For capa review time slack, check the source records and the supplied rule before comparing the result with another method. Use a separate evidence or method review when arithmetic consistency alone cannot establish the required conclusion.

References

  1. Calculation and input contract: quality-assurance/capa-review-time-slack — tool.io

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