The document discusses reaction plans, mistake-proofing, and process control plans. It provides details on 5 types of reaction plans that can be considered when creating a process control plan. It also describes mistake-proofing methods used to eliminate defects by preventing or detecting mistakes. Finally, it outlines 10 key elements and 7 attributes of an effective process control plan, including monitoring inputs/outputs, setting control limits, and defining methods for monitoring, reacting to problems, and validating processes.
The document discusses reaction plans, mistake-proofing, and process control plans. It provides details on 5 types of reaction plans that can be considered when creating a process control plan. It also describes mistake-proofing methods used to eliminate defects by preventing or detecting mistakes. Finally, it outlines 10 key elements and 7 attributes of an effective process control plan, including monitoring inputs/outputs, setting control limits, and defining methods for monitoring, reacting to problems, and validating processes.
The document discusses reaction plans, mistake-proofing, and process control plans. It provides details on 5 types of reaction plans that can be considered when creating a process control plan. It also describes mistake-proofing methods used to eliminate defects by preventing or detecting mistakes. Finally, it outlines 10 key elements and 7 attributes of an effective process control plan, including monitoring inputs/outputs, setting control limits, and defining methods for monitoring, reacting to problems, and validating processes.
The document discusses reaction plans, mistake-proofing, and process control plans. It provides details on 5 types of reaction plans that can be considered when creating a process control plan. It also describes mistake-proofing methods used to eliminate defects by preventing or detecting mistakes. Finally, it outlines 10 key elements and 7 attributes of an effective process control plan, including monitoring inputs/outputs, setting control limits, and defining methods for monitoring, reacting to problems, and validating processes.
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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!!!
