Complying with the requirement for Contingency Plans - 4.9.b.2

4.9 b2 I'm looking for ideas for complying with the requirement for a CONTINGENCY PLAN. I have never seen one or have any idea what should be included.

4.9 g1 I'm not sure how to apply this requirement for packaging and preservation of equiment, tools and gages. It is nested within the requirement for Preventative Maintenance.

If there is anyone with knowledge of these areas please post a response. There are very few web pages that address any 3rd QS edition questions or explain the changes. I'd appreciate any leads.

Thanks Kelly

[Marc]

At the risk of appearing stupid, which to some degree is the case, I'll put my 2 cents worth in on this.

Key to 4.9.b.2:
"Shall prepare contingency plans..."
Now - does this mean (prepare???) DOCUMENTED plans? Hmmmm????

I have never seen such documented plans but I know manu companies have them. Almost always for Key Equipment failure. I mean - Key equipment failure is a given...

And often for utility interruption. In fact, I have had clients with backup generators because interruption would be that dramatic. From this I would say that the plan would have to be tailored with consideraqtion to the business as a whole. If you run a metal stamping shop your plan might not be as complex and dramatic as if you run a computer chip (yes - admittedly - extremely day-night) manufacturer.

Labour shortages? Ummm - well, that's a bit of a streach for some companies. I would see this as a function of the HR. I would expect an HR person to have at least a background enough top realize s/he should have plans for labour fluctuations. The company should have data for turn-over and you'd consider extremes (like in todays market).

What you are looking at here is having some common sense approach - which you probably have - and we'll have to watch as a new round of interpretations surfaces.

As far as 4.9.g.1 - I guess an example might be dies. I did some work for one company which didn't give a damn - they stored customer dies on outside, unprotected racks. The QS folks as placing more responsibility on you to protect the investment. Another example might be a check fixture. But again, we're looking at common sense.

I haven't yet seen an acceptable procedure to address this. Maybe someone will post an example. I'd be happy to talk with you about some specifics if you want to give me a call.

As a QS auditor I would expect to see some kind of documentation concerning a contingency plan. The purpose of the contingency plan is to ensure you can get product to your customers if "something" happens -- barring and act of God.

For example in my company (I do QS audits on a per diem basis) we have a union and although my company does not have a history of work stoppages, we keep an contingency inventory around the time uniion talks are about to begin. As Marc said, I have also seen a lot of companies have emergency generators in the case of power failures.

As far as equipment is concerned, your procedure for use and storage of the equipment should already be described in your procedures for how to use it. Company calibration standards are of particular interest. If storage requirements are already described in your procedures a simple statement to this fact in your Quality Manual should be sufficient

As I suspected, the contigency plan can be anything my client would like it to be and can include an array of ways to address stoppages of all kinds. I do appreciate the leads: utility, labor, and material shortages/stoppages. The way to tackle them could be so diverse an auditor should be able to accept most solutions?

I plan to tuck the requirement for a procedure for gage and tool packaging and preservation into the procedures written for 4.15. I can appreciate the reason for the requirement since I too have seen tools and gages stored sloppily. That didn't stop a QS auditor from siting minor noncompliances during a 2nd edition audit. Did they REALLy need to add it to 3rd? Oh well.

THANKS!
Kelly Speiser

I'm trying to brainstorm possible occurences other than the three examples (utility interruptions, labor shortages, key equipment failures)given in 4.9.b.2 that might require some sort of reaction plan. If you have any real examples of emergency events that would require a contingency plan I would appreciate the input.

As I go through the differnt scenarios we have addressed in our contingency plan, I really can't come up with anything outside of the categories listed. We have plans for downed networks (key equipment), loss of key personnel (labor shortages) and lightening strikes (utility interruptions). The only other things that we cover that may not fall under these categories include chemical spills (we build semiconductors) that cause evacuations (prolonged or otherwise - although evacuations could be considered labor shortages I guess) and fires (normally a result of faulty equipment). Hope this helps.

[Dawn]

Can anyone tell me what exactly needs to be stated for contingency plans?
Thanks ahead of time.

[Marc]

Content of your contingency plans is related to the risks of your business and may include weather related stuff, failure of 'critical' manufacturing equipment and such. In addition, you will probably have a number of contingency plans. Maintenance must plan for catistrophic (spelling) equipment failure. Quality or metrology may have a plan for certain inspection and test equipment (say you have an x-ray inspection and only 1 x-ray machine). Etc. Etc. Some will be documented and some will not be (probably).

Hope this helps as a starter.