Control Plans

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 its product or service goals.

Source: MSB Global Quality

Element 4: Control Plans

10 Key Elements
1. Risk Management 2. Supplier Evaluation & Selection 3. Contracts & Agreements 4. Control Plan Methodology 5. Product Acceptance Activities 6. Supplier Performance & Monitoring 7. Supplier Development 8. Supplier Certification 9. Change Control 10. Supplier Corrective & Preventative Action

Control Plan Attributes

1. 2. 3. 4. 5. 6. 7. Process sequence Inputs/Outputs monitor Control limits for the process Method of monitoring/control Frequency of control Method of reaction to problems Validation/Qualification information

Control Plan Attributes

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

Control Plan Attributes

2. Inputs/Outputs monitor
Process inputs such as temp, time, speeds, feed rate Point to validations for process inputs List them individually on the CP Special processes (ex-passivation time & temp)

Control Plan Attributes

3. Control limits for the process
List all critical features for the product being manufactured and the tolerance that is allowed for these features List acceptable ranges for process controls

Control Plan Attributes

4. Method of monitoring/control
Define how the feature will be checked and how these checks are controlled (SPC, Validation, visual, etc) G R&R or MSAs for inspection equipment can be listed here as well

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

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

Control Plan Attributes

7. Validation/Qualification information
Actual protocol or document #s for: All special processes must be validated