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Control Plans

A control plan is a process management tool used to identify and monitor critical inputs and outputs of a process to ensure goals are continually met. Key elements of a control plan include risk management, supplier evaluation, contracts, control plan methodology, product acceptance, supplier performance monitoring, development, certification, change control, and corrective action. Attributes of a control plan outline the process sequence, inputs/outputs monitoring, control limits, monitoring methods, monitoring frequency, problem reaction methods, and validation/qualification information.

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3K views12 pages

Control Plans

A control plan is a process management tool used to identify and monitor critical inputs and outputs of a process to ensure goals are continually met. Key elements of a control plan include risk management, supplier evaluation, contracts, control plan methodology, product acceptance, supplier performance monitoring, development, certification, change control, and corrective action. Attributes of a control plan outline the process sequence, inputs/outputs monitoring, control limits, monitoring methods, monitoring frequency, problem reaction methods, and validation/qualification information.

Uploaded by

aman_ranhotra
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd

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

Control Plans
Control Plan Definition •Control Plan • Control Plan - (n) a Process Management tool used to identify and monitor the activi
Element 4: Control Plans 10 Key Elements 1. Risk Management 2. Supplier Evaluation & Selection 3. Contracts & Agreement
Control Plan Attributes 1. Process sequence 2. Inputs/Outputs monitor 3. Control limits for the process 4. Method of moni
Control Plan Attributes 1. Process sequence List all steps used during the manufacturing process List all machines or to
Control Plan Attributes 2. Inputs/Outputs monitor Process inputs such as temp, time, speeds, feed rate Point to validati
Control Plan Attributes 3. Control limits for the process List all critical features for the product being manufactured an
Control Plan Attributes 4. Method of monitoring/control Define how the feature will be checked and how these checks are c
Control Plan Attributes 5. Frequency of control How often will this dimension be inspected Capability must be establishe
Control Plan Attributes 6. Method of reaction to problems Who is responsible for monitoring Procedure to follow if a def

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