Receiving a 'Major' (Hold Point) during an Interim Assessment

[Alf Gulford]

It seems kind of silly to ask this question after running internal audits for several years but, is there a well defined consequence for receiving a 'major' or hold point during an interim assessment (to continue registration)? Most of my sources say that initial registration will be withheld until the matter is corrected and that there are some kind of approvals or discussions possible. I haven't found anything yet about 'continuing' assessments.

The question will be going in to our registrar and I've been asked to find some kind of 'official' documentation to answer the question.

I'd appreciate any guidance here. Thank you.

[Marc]

> is there a well defined consequence for
> receiving a 'major' or hold point during an interim assessment (to
> continue registration)?

If you are already registered a major finding will generally require a CA plan within a week or so and a revisit in 6 weeks or so to verify you implemented the CA and that it is effective. If it's not severe (foggy definition of severe....) they may elect to verify at their next visit. But even here it may depend upon whether you are on a 6 month or 1 year cycle. If you're on a six month there is much lower risk for them to 'trust you' (by waiting until their next scheduled visit to verify) than if you're on a 1 year cycle. (This is all ISO, of course, not QS.) But - as far as I know it's registrar dependent. And situation dependent. That is, the auditor and your upper management would discuss what the major is with consideration to its percieved severity. If your internal audit system is broken (indirect effect on product), for example, you would probably get more latitude than if your calibration system was broken (direct effect on product).

I have never heard of a company loosing its cert immediately after receiving a major (after they were actually registered) but I suppose things could get bad enough that a registrar could do so. Maybe someone else has some knowledge about this aspect.

Harley (York) 'failed' a cycle assessment with several majors last year and was given 6 months to 'shape up'. The cert was not pulled.

> Most of my sources say that initial
> registration will be withheld until the matter is corrected and that

If you are not already registered, they will hold the cert until the matter is resolved. That is, until you submit a CA plan (at least). If severe they may elect to come back to verify before they release the cert.

Alf,

You can find some additional information on this topic (for QS-9000) in the IASG Sanctioned Interpretations as amended on February 29, 2000. Look under the Registration / Accreditation (R) section for question R3 Probation and Delisting of Suppliers.

Best Regards,

Jim

It is my understanding from a conversation I recently had with our registrar that the Sanction Interpretations are just interpretations. There is no requirement for registrars to place an organization on "Probation" if there is continuous major problems with their corrective action system. I know of an organization who is appealing their registration having been "pulled", and in their appeal they cited the February 2000 Interpretations and not being placed on probation prior to having their registration suspended. Has anyone else come across this problem?

[Tom Goetzinger]

As stated in the Sanctioned Interpretations, "Because these interpretations are a binding extension of the DaimlerChrysler/Ford/General Motors Qualtiy System Requirements, QS-9000:1998 Third Edition, ....."
These interpretations are, in fact, an extension of the standard and as such are as binding as any other part of the standard. Failure to conform is subject to the same penalties as failing to conform to any other part of the standard.

[richard b. thomas]

If the sanctioned interpretations state that a supplier can be placed on probation if their quality system demonstrates continuous problems such as ineffective corrective action implementation, follow-up and verification but the registrar decides to recommend suspension of the supplier certification, does this meet the intent of the February 2000 Sanctioned Interpretation? The appeal by the supplier is based on not being placed on probation first not that their quality system has demonstrated continuous systemic breakdowns over time. Does anyone believe the grounds for appeal is justified?