View Full Version : PFMEA Risk Assessment - Transfer of Production to a New Building (Relocation)
brutas 18th September 2006, 05:10 AM Please help
Can you give me advice how deal with risk assessment regarding transfer of production to a new building (relocation).
The process is testing of ICs and since we are moving to a new building our customer wants to see risk assessment for this transfer.
I want to use the PFMEA technique. How to define this process of transfer? What requirement have to be set?
For me I should consider:
shipments, production lead time, safety stock, product quality, equipment validation...
The goal is to keep the same shipments to the customer with the same product quality.
What do you suggest?
Jim Wynne 18th September 2006, 09:18 AM Please help
Can you give me advice how deal with risk assessment regarding transfer of production to a new building (relocation).
The process is testing of ICs and since we are moving to a new building our customer wants to see risk assessment for this transfer.
I want to use the PFMEA technique. How to define this process of transfer? What requirement have to be set?
For me I should consider:
shipments, production lead time, safety stock, product quality, equipment validation...
The goal is to keep the same shipments to the customer with the same product quality.
What do you suggest?
The fact that you're unsure of the requirements leads me to believe that the traditional AIAG-type PFMEA might not be a good fit. There are a lot of factors involved that we're not privy to, such as whether you intend to do production in the present location until the new one is up and running.
One thing you should do is look for opportunities to improve the process. Sometimes when a production process is run in the same place for a long time, there is reluctance to mess with it if everyone is happy and customers aren't complaining. You can look at your present PFMEA, if you have one, for clues as to what advantages there might be in updating the process in the new location.
What your customers are concerned about is getting a steady flow of product throughout the transition, and assurance that the process in the new location is at least as reliable as what they're accustomed to. You should start with an understanding of all of the elements involved in the move, and a timeline, from which you can construct a flowchart. In PFMEA style, you should address each element for potential risks and develop strategies for prevention of glitches. Thus far this resembles an AIAG PFMEA, but I see no need for RPNs; a simple statement of the potential risks at each step and how they are addressed will suffice. As I suggested, you should also take the opportunity to show your customers that you're thinking about improvements, so that you can assure them that not only is the risk to them negligible, but they will ultimately benefit from the move.
potdar 19th September 2006, 04:06 AM Please help
Can you give me advice how deal with risk assessment regarding transfer of production to a new building (relocation).
The process is testing of ICs and since we are moving to a new building our customer wants to see risk assessment for this transfer.
I want to use the PFMEA technique. How to define this process of transfer? What requirement have to be set?
For me I should consider:
shipments, production lead time, safety stock, product quality, equipment validation...
The goal is to keep the same shipments to the customer with the same product quality.
What do you suggest?
Brutas,
My suggestion would be to find out what exactly the customer means by 'risk assessment'. I dont know whether you are in automotive industry, but borrowing from their books, the customer is specifically bothered on three issues - Quality, Cost and Delivery.
Regarding product quality, the procedure of PPAP has been defined to ensure delivery of consistent quality product to the customer. It also requires that you notify the customer if you shift your production facilities to a new location and submit a modified PPAP if he so desires. That covers quality consistency.
Cost is a commercial aspect, better left to the commercial people. Inhouse we can improve on it using continual improvement techniques.
Delivery consistency would be ensured by planning your shifting schedules and stocks in tune with the customer's requirements. Additional security is provided by means of having a guaranteed contingency arranement to take care of any unforeseen situations.
These factors taken together should satisfy your customer's concerns. pFMEA wouldnt be the appropriate method.
Bill Ryan 19th September 2006, 09:12 AM If you are "doing" the Flow Diagram, PFMEA and Control Plans per the manuals, each document would need to be updated to show the revised processing flow. I do agree with Jim and Potdar that the PFMEA document, as detailed in the manual, may not be the correct tool as there are different formats for risk management reporting, however, the PFMEA methodology is certainly appropriate for helping manage the change.
Jim Wynne 19th September 2006, 10:10 AM the PFMEA methodology is certainly appropriate for helping manage the change.
An excellent point. PFMEA is a process, not a document, and there are four simple steps:
Break the process down into individual steps
Identify what might go wrong in each step, and between steps.
Think of ways that you can prevent those things from going wrong.
Understand that in any given case, the cure might be worse than the disease, and be judicious in implementing prevention strategies.When asking for risk analysis, the customer wants to have some assurance that this process has been followed, and the form that the output takes (the way the results are communicated to the customer) is generally not as important as the fact that results are effectively communicated.
rstaz 19th September 2006, 10:39 AM Hi Brutus,
I led our production relocation last year. I find it strange to consider doing a pFMEA on a one-time event. I compiled a "Quality Plan" and included such things as inventory transfer, machine qualification, notification of customers, etc. We had many departments contributute to the plan and approve it long before the move happened.
Jim Wynne 19th September 2006, 10:50 AM Hi Brutus,
I led our production relocation last year. I find it strange to consider doing a pFMEA on a one-time event. I compiled a "Quality Plan" and included such things as inventory transfer, machine qualification, notification of customers, etc. We had many departments contributute to the plan and approve it long before the move happened.
You did do a PFMEA; you just didn't document it using the AIAG form. :D
Nissim Shaked 19th September 2006, 11:40 AM Dear Brutas
I would go into the new facility and look for parameters like:
* Any hazards arising from new location of dangerous materials?
* New hazards arising from the new location of the outgoing waste (like contamination of clean room …)?
* Hazards due to rusty locations in the new facility?
* Hazards due to cross contamination of two deferent production lines that now are very close one to another?
And so on…
Nissim
allenlee 1st October 2006, 07:46 AM If I'm the customer, I would like to see "how do you manage the changes", any impact to product quality, delivery..., how to evaluate them, what's the results..., basically, shall follow PPAP concept to convince customer to accept the changes, not only FMEA can cover.
tomvehoski 2nd October 2006, 11:10 AM We have a simplified version of FMEA for every day business and project risk assessment. Risks are brainstormed based on the plan and rated by Severity (1-3, 3 being high) and Probability (1-3). This gives a simplified RPN of 1, 2, 3, 4, 6, or 9. We then code as Red (9), Yellow (3-6) or Green (1-2). Action plans are then developed and tracked for the red and yellow. Green are monitored.
Say you were building a new facility. A risk might be that it would not be ready in time. This would be severe (3) as you could not build product (assuming you can't stay in the old facility). If you know it is behind schedule, the weather is going to hold up construction, labor shortages and so on, it would get a probability of 3 and an RPN of 9 and you better get an action plan going. If you have six months of leeway, the building is almost ready, etc it would be a 1. Just monitor the situation to make sure nothing catastrophic happens.
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