Control Plan Checklist
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Process Definition & Documentation
Ensures the process is clearly defined and documented, forming the basis of the control plan.
Process Name
Process Description (including flow)
Process Location(s)
Process Step Number(s)
Equipment/Machines Used
Process Flow Diagram (PFD)
Raw Materials Used (and suppliers)
Critical Process Parameters (CPP)
Identifies and validates the process parameters that directly influence product quality.
Temperature (during process X)
Pressure (during process Y)
Cycle Time (seconds)
Material Type
Feed Rate (units/minute)
Equipment Status
Justification for CPP Selection
Control Methods & Procedures
Details the methods used to monitor and control CPPs, including inspection, measurement, and corrective actions.
Inspection Frequency for CPP X
Maximum Allowable Variation for CPP Y
Detailed Procedure for Measuring CPP Z
Equipment Used for CPP Measurement (e.g. Caliper, Gauge)
Methods for CPP Control
Date of Last Calibration for Measurement Equipment
Time of CPP Measurement
Measurement System Analysis (MSA)
Verifies the accuracy and reliability of measurement systems used to monitor CPPs.
Repeatability (r) Value
Reproducibility (R) Value
Equipment Variation (Ev) Value
Operator Variation (Ov) Value
Gauge Repeatability and Reproducibility (GR&R) %
MSA Study Type Performed (e.g., PPAP, Gage R&R)
Summary of MSA Study Findings and Conclusions
MSA Study Result (Overall Assessment)
MSA Study Completion Date
Process Capability & Performance
Evaluates the process's ability to consistently meet specifications.
Process Cp (Current Process Capability)
Process Cpk (Current Process Capability Index)
Target Cp (Desired Process Capability)
Target Cpk (Desired Process Capability Index)
Date of Capability Study
Summary of Capability Study Results and Analysis
Description of any actions taken to improve process capability.
Number of Samples Used in Capability Study
Is the process currently capable? (Based on target Cpk)
Control Plan Implementation & Training
Confirms that the control plan is implemented correctly and that personnel are adequately trained.
Number of personnel trained on the Control Plan
Date of most recent Control Plan training
Summary of Control Plan training content (key topics covered)
Training Method Used (e.g., Classroom, Online, On-the-Job)
Departments Receiving Control Plan Training
Verification Method for Training Effectiveness (e.g., Quiz, Observation)
Notes on any deviations from the planned training schedule or content.
Control Plan Review & Updates
Ensures the control plan is periodically reviewed and updated based on performance data and changes to the process.
Last Control Plan Review Date
Frequency of Control Plan Review (in months)
Summary of Review Findings & Changes
Areas Reviewed During Update (Select all that apply)
Rationale for Changes Made (if applicable)
Impact of Changes on Process Capability (e.g., Sigma Level - if applicable)
Approval Status of Updated Control Plan
Reviewer Signature
Reaction Plan (Corrective Action)
Details the steps to be taken when a CPP falls outside of acceptable limits.
Severity Level of Deviation
Detailed Description of Deviation
Root Cause Analysis Documentation
Corrective Action Proposed
Date Corrective Action Implemented
Effectiveness Verification Method
Effectiveness Verification Result (e.g., % improvement)
Verification Result
Additional Comments/Notes
Signature of Person Implementing Correction
Record Keeping & Traceability
Ensures proper documentation of all data related to the control plan and traceability of products.
Date of Record Creation
Lot/Batch Number
Operator Notes/Comments (any deviations from standard)
Quantity Produced
Record Status (e.g., Complete, Pending Review, Approved)
Attach Supporting Documentation (e.g., Calibration Certificates, Inspection Reports)
Method of Traceability (e.g., Serial Numbers, Barcodes, Batch Codes)
Description of Traceability Method and its Scope
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