Reaction Plan
Reaction Plan
Reaction Plan
Prevention- Not allowing the possibility for the mistakes to occur in the
first place
When to Use Mistake–Proofing
• When a process step has been identified where human error
can cause mistakes or defects to occur, especially in processes
that rely on the worker’s attention, skill or experience.
• In a service process, where the customer can make an error
which affects the output.
• At a hand-off step in a process, when output or (for service
processes) the customer is transferred to another worker.
• When a minor error early in the process causes major
problems later in the process.
• When the consequences of an error are expensive or
dangerous.
Process Control Plan
Control Plan - 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
it’s product or service goals.
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. 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
Control Plan Attributes
a. 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 MSA’s for inspection equipment can be listed
here as well
Control
5. Frequency of control
Plan Attributes
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
THANK YOU!!!