Control Plan Adherence Audit

Inspection template for auditing adherence to a manufacturing control plan, including CTQs, inspection frequencies, measurement systems, and reaction plans.

Control Plan Availability and Revision Control

• Current approved control plan is available at the workstation
• Control plan revision matches the latest released document
• CTQs, inspection points, and reaction plans are clearly identified in the control plan
• Temporary deviations or containment actions are documented and authorized

CTQ Characteristics and Product Checks

• Required CTQ characteristic is being checked at the specified operation
• CTQ acceptance criteria match the control plan specification
• Inspection results are recorded for each required lot, batch, or unit
• Measured CTQ value
• CTQ result status

Inspection Frequency and Timing

• Inspection frequency matches the control plan requirement
• Last inspection time
• Next inspection due time
• Inspection interval in minutes

Measurement System and Equipment

• Measurement device or gauge is identified in the control plan
• Measurement device is within calibration date
• Measurement method is appropriate for the CTQ and provides required resolution
• Measurement system identification
• Calibration due date

Reaction Plan and Escalation

• Reaction plan is defined for out-of-spec CTQ results
• Operator can describe the immediate containment action
• Escalation path to supervisor, quality, or engineering is posted and understood
• Recent non-conformance or stop-call-fix record reviewed
• Reaction plan response time in minutes