Reaction Plan

• Reaction Plan is the series of steps

that you would take in response to
a specified abnormal condition.
• A reaction plan helps to minimize
damage. It reduces the time
between the occurrence of a
problem and a stop gap.
 Reaction Plan
There are 5 different types of reaction plans that
can be considered while creating a process control
plan:
1. A plan to continue the process with close
monitoring
2. Enforce a manual override
3. Follow special instructions
4. Stop and escalate
5. Stop, correct, and resume
 MISTAKE–PROOFING
• Also called Poka-Yoke
is a mistake proofing method that eliminates mistakes
and defects, ensuring quality products and services. It originated
from Japanese lean manufacturing.

Awareness –Having a forethought that a mistake can be communicating

the potential and planning the design of the product or process to detect
or prevent it.

Detection- Allowing the mistakes to happen but providing some means

of detecting it and alerting someone so that we fix it before sending it to
our customer.

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!!! 