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Dear good people,
I'm looking for your opinion.
We are doing a review in our PFMEA and Control Plan, we want to ensure all PFMEA and Control Plan have a linkage.
What we understand are
1. "Requirement" in PFMEA may be become "Product Characteristic" in control plan. and "Cause" in PFMEA may be become "Process Characteristic" in control plan.
2. "Requirement" is contain with what process intend to build. or defined as "Product Characteristic"
3. We start to build flow chart before we build PFMEA.
The current condition is,
1. We define our PFMEA for process A as
2. We define our Control Plan as
I already asked this idea for many times to different person and the answer always different with :
a. "Requirement" is both process characteristic and product characteristics. You can put "drum width, pressure, temperature, production volume, separate the non conformance, set up, etc" in requirement.
b. "Requirement" is only product characteristic. We need to think what "product characteristic" in macro process A that related in every micro process.
c. "Requirement" is both process characteristic and product characteristic. During preparation is process characteristic, during inspection is process characteristic. Except that you should define as product characteristics.
What do you think about this? Which one you think is more acceptable. Or maybe you have better theory. Thank you
I'm looking for your opinion.
We are doing a review in our PFMEA and Control Plan, we want to ensure all PFMEA and Control Plan have a linkage.
What we understand are
1. "Requirement" in PFMEA may be become "Product Characteristic" in control plan. and "Cause" in PFMEA may be become "Process Characteristic" in control plan.
2. "Requirement" is contain with what process intend to build. or defined as "Product Characteristic"
3. We start to build flow chart before we build PFMEA.
The current condition is,
1. We define our PFMEA for process A as
- Material Preparation - This process is to prepare material as specification
- Requirement : Material not expired
- Failure : Material expired
- Cause : Operator using expired material
- Effects : Product easy to separate and explode
- Machine Preparation - This process is to prepare machine condition as specification
- Requirement : Drum circum
- Failure : Drum circum too big
- Cause : Operator using wrong drum circum
- Effect : Product outer circum not meet with regulation
- Assembly
- Final Check - This process is to check product outer circum after assembly
- Requirement : Product outer circum comply with standard
- Failure : Product outer circum too big
- Cause : Operator using wrong drum circum
- Effect : Product outer circum not meet with regulation
- Storage
2. We define our Control Plan as
- Material Preparation
- Product Characteristic : Material identification
- Machine Preparation
- Process Characteristic : Drum circum
- Assembly
- Final Check
- Product Characteristic : Product outer circum
- Storage
I already asked this idea for many times to different person and the answer always different with :
a. "Requirement" is both process characteristic and product characteristics. You can put "drum width, pressure, temperature, production volume, separate the non conformance, set up, etc" in requirement.
b. "Requirement" is only product characteristic. We need to think what "product characteristic" in macro process A that related in every micro process.
c. "Requirement" is both process characteristic and product characteristic. During preparation is process characteristic, during inspection is process characteristic. Except that you should define as product characteristics.
What do you think about this? Which one you think is more acceptable. Or maybe you have better theory. Thank you