QS9000 Laboratory and Calibration Requirements

[Marc]

Laboratories and Calibration requirements in the QS-9000 Third Edition

Dispelling Rumors

• 4.10.6 Requirements for an In-House Laboratory
• 4.11.2.b.1 - Requirements for Calibration Services
• Cost

QS-9000 registered suppliers, who wish to remain registered, will need to implement the QSR Third Edition changes by January 1999. The QSR Second Edition ceases to exist January 1, 1999. Most suppliers are aware of these facts.

But what isn't as clear to most suppliers, are the details about the specific changes to the Requirements brought on by the Third Edition. And, most importantly, what the changes mean to the their quality management system.

"What do we need to do to comply?"

Two requirements in the Third Edition that are creating a lot of questions are 4.10.6 - Supplier Laboratory Requirements and 4.11.2.b.1 - Calibration Services.

What follows is an explanation of both 4.10.6 and 4.11.2.b.1 directly from the Supplier Quality Requirement Task Force, the Big Three's team who facilitates the creation and maintenance of the QS-9000 Requirements.

In addition, the explanation is followed by an offer of extra help and a way to get it.

4.10.6 - Requirements for an In-House Laboratory

• Compliance to ISO Guide 25 is not required per se
• Compliance to QS-9000 Requirements including 4.10.6.1 - 4.10.6.6 is required
• What is a lab? A facility, a building, a special room, a designated area, etc., that facilitates (makes possible) an activity where testing is done.
• What isn't a lab? Places where testing occurs as a part of a process, which are within the parameters of that process. In other words, if testing is adequately controlled by in-process testing and inspection, and the items to be tested are not taken out of the process to a "facility," the in-house laboratory requirement does not apply.

Lab requirements:

Scope - answers the questions: What is the reason for the activity? What the elements/rules/laws/procedures that will be included in the activity? Who or what is affected by the activity? More specifically, the definition from the QSR: A quality record (see 4.16) containing the following:

• the specific tests, evaluations and calibrations a supplier laboratory has the ability and competency to perform
• a list of the equipment which it uses to perform the above
• a list of the methods and standards to which it performs the above

Lab personnel - professional judgements require theoretical and practical experience.

• Test samples - must be retained and/or disposed of by procedures.
• Environment controls - must be adequate.
• Methods - must meet the needs of the customer and meet current standards. The lab must verify its capability to perform to standard specifications.
• Statistics - must be appropriate to the work done.

4.11.2.b.1 - Requirements for Calibration Services

• What/Who qualifies to do calibration?
• Qualified in-house labs (yours or another supplier's)
• Qualified commercial/independent labs who are accredited to ISO/IEC Guide 25 (Not ISO 9001, which is a quality management system standard; also, be aware that the number of Guide 25 accredited labs may be limited and that some of the accredited labs may only be qualified in a specific area)
• Or a national equivalent
• Or have evidence of an assessment by an OEM customer or an OEM customer approved second party, that they meet the intent of ISO/IEC Guide 25 or national equivalent (an example an OEM customer approved second party is the effort by a Project Team currently meeting at AIAG for the purposes of putting together a second party assessment process for auditing commercial labs to ISO Guide 25)
• Or where a qualified lab does not exist for a piece of equipment, calibration may be performed by the original equipment manufacturer or the original manufacturer's recommended calibration provider
• Or some customers recognize certificates to ISO Guide 25 that have been issued by registration/certification bodies that are compliant to ISO Guide 58
• Or by special arrangement - some testing may be done by the customer's lab facility
• Or a combination of any or all of the above

Cost

• The cost for bringing an in-house lab into 4.10.6 compliance will depend upon the scope of the lab and the upgrading needed in terms of personnel, equipment and methods. Many suppliers, much like in the original implementation of QS-9000 Requirements, will find that they have many or most of the lab requirements already in place (due to prior customer lab requirements); the task now becomes putting the pieces into a workable system.
• The cost for becoming accredited to Guide 25 will again depend upon scope and the upgrading needed in terms of personnel, equipment and methods. A checklist for Guide 25 compliance can be obtained on the A2LA (American Association for Laboratory Accreditation) web-site - www.a2la.org or by contacting SCC (Standards Council of Canada) at - info@scc.ca. (Once again, a reminder that Guide 25 compliance is not required of an in-house lab.) Generally, if only a few tests or calibrations are required to be done at the facility, a one day on-site audit should suffice - estimated costs per auditor day range from $650 - $1500 U.S. (Lab audit and compliance/registration costs, much like the original, exaggerated QS-9000 audit and compliance/registration cost-estimates, are in reality a fraction of their rumored costs.)
• The cost of "having evidence" of an assessment by an OEM customer-approved second party is again dependent upon the factors listed above, but on the surface appears to be the least expensive
• The cost of customer-approved certifications by certification/registration bodies other than A2LA can be obtained from the certification/registration bodies

Compliance to 4.10.6 or 4.11.2.b.1 (or 4.10.7) was not intended to be onerous. Much flexibility was placed into the requirements so that suppliers (and independent labs) can meet the needs of the OEM customers in the most expedient and cost effective manner.

The bottom line for the inclusion of the requirements and their implementation by suppliers is to insure that all testing, measuring and inspecting activities are controlled, can be confirmed and produce results that can be trusted.

[This message has been edited by Marc Smith (edited 01-13-99).]

[Marc]

An FYI:

----------snippo---------

Date: Tue, 12 Jan 1999 22:17:43 -0500
From: Nancy Foncannon
To: Greg Gogates
Subject: Re: Scope of Calibration for QS9000 Third Edition

Brian: The only source for official help comes from AIAG and its affiliate, the Plexus Training Corp. Whatever "opinions" you may get from the general public are just that: opinions. You can view the AIAG/Plexus "interpretations" at their web site. Then click at the first line that states getting more information on the QS-9000 changes. The information posted covers the changes to 4.10 and 4.11 sections of QS-9000.

Their definition of Scope is somewhat different than a "Scope of Accreditation" as defined by A2LA, as you stated in your message. Also, please note that I am not "selling" the Plexus services, just using that as a source of information. In fact, AIAG and Plexus have their hands in each others' pockets (financially speaking, that is :=)) and are tying up the "training rights" of the free enterprise system. But let's not get on that soapbox!

So, after checking out that information, give your current Registrar a call. They are not allowed to give consulting. However, they can tell you if you are headed in the right direction, according to their mode of thinking at the present time. But face it, what's the worst thing that can happen during the QS-9000 audit? A minor non-conformance for an incorrectly defined Scope! So, don't loose too much sleep over the issue at this point. There is also a strong rumor that AIAG will delay implementation of the 4.11.2.b.1 change.

Hope this helps. Regards, Nancy.
ISO/QS/Guide 25 Auditor, Trainer & Consultant

MARK,
IS THERE ANY WORD ON WHEN THE AIAG WILL MAKE THE DECISION ON DELAYING THE REQUIREMENT FOR 4.11.2.b.1. WE HAVE OUR QS9000 AUDIT ON THE 25TH OF JAN. THIS IS PROBABLY MY 1 MAJOR HANGUP IN MY CALIBRATION SYSTEM.
THANKS, SCOTT

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[Marc]

I believe there is some info on this but I forget which forum and thread. Do a search here in the forum (see near top of page) on 4.10.6 and 4.11.2 and it should pop up. I believe the thread is in the Calibration forum but I'm not sure.

Off hand I am not aware of any 'official' declaration of an 'official' delay.

Ahhhh! See:

This Thread.

[This message has been edited by Marc Smith (edited 01-14-99).]