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Control Plans

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Control Plan Definition

Control Plan - (n) a Process Management tool

used to identify and monitor the activities required

to control the critical inputs and key outputs for a

process, so the process will continually meet itsproduct or service goals.

Source: MSB Global Quality

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Element 4: Control Plans

10 Key Elements1. Risk Management

2. Supplier Evaluation & Selection

3. Contracts & Agreements4. Control Plan Methodology

5. Product Acceptance Activities

6. Supplier Performance & Monitoring

7. Supplier Development

8. Supplier Certification

9. Change Control10.Supplier Corrective & Preventative Action

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Control Plan Attributes1. Process sequence

2. Inputs/Outputs monitor

3. Control limits for the process

4. Method of monitoring/control

5. Frequency of control

6. Method of reaction to problems

7. Validation/Qualification information

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Control Plan Attributes

1. Process sequence List all steps used during the manufacturing process

List all machines or tools used

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Control Plan Attributes

3. Control limits for the process List all critical features for the product being manufactured and thetolerance that is allowed for these features

List acceptable ranges for process controls

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Control Plan Attributes

4. Method of monitoring/control Define how the feature will be checked and how these checks arecontrolled (SPC, Validation, visual, etc)

G R&R or MSAs for inspection equipment can be listed here as well

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Control Plan Attributes

5. Frequency of control How often will this dimension be inspected

Capability must be established for a sampling plan to be in place

The level of inspection should be related to the level of risk that is

associated with the process or product characteristic

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Control Plan Attributes

6. Method of reaction to problems Who is responsible for monitoring Procedure to follow if a defect is found

MCDR, QC SOP#, segregate and reprocess, adjust tool, etc

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Control Plan Attributes

7. Validation/Qualification information Actual protocol or document #s for:

All special processes must be validated

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