Control Plan Checklist

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Process Definition & Documentation

1 of 9

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)

2 of 9

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

3 of 9

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)

4 of 9

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

5 of 9

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

6 of 9

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

7 of 9

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)

8 of 9

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

9 of 9

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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