How do you control your Hold area? Cage needed to be under lock and key?

[AndyN]

You could always find a way to not need such a place............ Then the need for 'control' goes away.........

Your auditor is way off base here. Even if you locked it up (needed to) you'd still have folks get in there - unless Randy's mother in law never sleeps..........

So, call your registrar and tell them you don't want this guy back and that you're not taking any action on a waste of time issue like this.........

Andy

 

[tony wardle]

The good 'ol lock and key story came up with us after we were audited by one of our suppliers. We had a good look at 8.3 Control of nasties, and also did not quite find the trems "cage", "lock" or "key". But, because the customer so wanted this, we asked him to give us a spec of waht he wanted so that we could cost this captital expense into the part that he buys, and amortise it over a period. It was afterall a CSR exclusively for him.
The customer came back to us - a big orange sticker would do.

I think part of the deal is that as customers we want to get as much as we can out of our suppliers as possible without any expense to ourselves.

 

[ralphsulser]

The good 'ol lock and key story came up with us after we were audited by one of our suppliers. We had a good look at 8.3 Control of nasties, and also did not quite find the trems "cage", "lock" or "key". But, because the customer so wanted this, we asked him to give us a spec of waht he wanted so that we could cost this captital expense into the part that he buys, and amortise it over a period. It was afterall a CSR exclusively for him.
The customer came back to us - a big orange sticker would do.

I think part of the deal is that as customers we want to get as much as we can out of our suppliers as possible without any expense to ourselves.

This was a good method. I always say, we can do anything you want. When do you need a quote, and who shall I send it to.

 

[RoxaneB]

Tony...loved that idea! Hoping ASchmidt can apply it. Or they can hire Randy's first mother-in-law and bill her food and keep to the Customer.

 

[antho10359]

This sounds like bleed-over from pharmaceuticals. I have worked in the drug and medical device industry for many years and physical containment of hold, quarantine or re-work product is common practice.

Much of this physical containment concept is left over from the days before electronic inventory tracking and bar-codes. The newer systems allow for "electronic quarantine." Chances are the inspector is a hold-over from that era and that is what they are comfortable with or it is a younger person and "that's the way it was always done" but they don't know why.

The only regulation that I am aware off that spells out specific requirements for securing product is in 21 CFR 1301.71 (et al).

 

[Caster]

TS doesn't require lock and key. It wants control of nonconforming product but it does not say how.

If I recall the old Chrysler SQA quality manual that pre dated QS 9000 required a locked cage for held products.

Anyone still have a copy? Anyone else recall that?

Locks are only for honest people, ask any thief.

 

[ralphsulser]

I remember GM & Chrysler telling us that they preferred this method of controlling nonconforming products. We decided to go ahead and do it. We had an area out of the production flow, so got a contrator to come in and put up a 6 ft. chain link fence with a gate. We put a lock on it and it worked OK for us. These were small parts, and a small plant so not a lot of issues.
The GM & Chrysler Quality Reps. were happy when they came in, and we got more business too. This was pre-QS9000 in about 1982

 

[ASchmidt]

This helps! Our end product is used by GM, so we might as well go by their standards, as much as possible. Satisfy the customer!

 

[WCHorn]

I'm very sure there is no requirement to hold under lock and key. This is the kind of thing your top dog should take up at a high level with customer's top dog.

Simply, not every customer's agent is the sharpest tack in the box. You'd be astounded how many officious martinets make up rules as they go along because they are embarrassed to show their ignorance of the real rules.

This has been known to occur with official auditors from 3rd party registrars, just not as frequently.

Your post is so applicable to a customer who just today said nonconforming product must be under lock and key. I was tempted to send him this string, but he might take offense to Wes' second paragraph. Wes - that is hilarious. It's so interesting how much someone can read into a simple sentence!

 

[tony wardle]

We had the same - Our customer was adamant that NC goods WILL be under lock and key. No problem - we explained that this was THEIR request and so the cost will be for their account. We sent them an estimate - and surprise surprise they changed their tune.... Would this work for you?