Chapter 22: Case Study 1: The Growth Corporation Upgrades to ISO 9001:2000


22.1 Choice Point

22.1.1 Author's Introduction

The result of the effort to create an effective Growth Corporation Quality Management System (GCQMS) Manual is the gist of this first case study. The pages in this book, from the GCQMS cover page in Section 22.3 until the end of the case study in Section 22.8, form a contiguous ISO 9001:2000 manual that conforms in detail with the Standard.

The screened type represents the text from the 1994 manual that was described in my previous ISO 9001:1994 application-oriented book.

The black type represents the additional responses needed to bring the old manual into conformance with the Standard. As you scan the pages you can readily discern that Section 22.4 contains the greatest amount of additional material. Because there are over 420,000 1994 manuals already written, this case study should give you an excellent idea of what your upgraded manual will look like. For those who are creating their first manual, it is a practical example of what your manual should look like if you apply the design rules described in this book.

Interestingly enough, the design rules that had been used to create an effective QMS:1994 have been essentially invariant under the QMS:2000 transformation. This is not surprising because the design rules are generic to the extent that they are applicable far and beyond ISO 9000 documentation and implementation. For example, the concept of shall analysis is applicable to any proposal/quote written against a given set of requirements typical of a Department of Defense or NASA request for proposal (RFP) or request for quote (RFQ). Moreover, even if you do not have a copy of my ISO 9001:1994–oriented book, you can readily determine how to create the upgraded QMS by studying this book and also analyzing the second case study, which follows Growth's first certification process in detail.

Now, let us look in on Fran and Mike as they make the decision to go ISO 2000.

22.1.2 An Upgrade Decision

Growth's fifth maintenance surveillance came to a highly successful conclusion—zero nonconformances. In addition, several interesting and valuable opportunities for improvement were offered by the lead assessor, who was now on his way to the next audit.

Fran, the president and CEO of Growth, Inc., remained in the same conference room where the closing meeting had taken place, along with Mike, the vice president of quality assurance. Both were relaxed and satisfied with the surveillance's results and were sipping down some diet cola and munching on the large sugar cookies that were a staple at Growth. The ambiguity between lowered calories in the cola versus a gigantic load of calories in the cookies never seemed to be an issue at Growth. People needed that sugar!

Fran began the dialogue. "Mike, it seems impossible. We're only 6 months away from the recertification audit. Where did those 3 years go?"

Mike smiled warmly, "Well we did a lot in that time. We got certified, we got raised to a wholly owned subsidiary—as we planned—we've landed some really fine OEM contracts, we've pulled off that cost-reduction program that was really key to our profitability, and we both have 'president' in our titles. Not bad, I'd say."

Fran agreed completely with Mike's quick summary of their progress. The past was fine, but where to go from here was her main concern. "Tell me, Mike," Fran questioned, "I've heard a great deal about the new ISO version—especially from you. Shouldn't we upgrade to ISO 2000 about now?"

Mike pondered the question a bit, then replied, "Well, we have some time before December, 2003, when it becomes mandatory. However, in six months, when we recertify, we get a new certificate. I've been talking to Sam about what needs to be done, and he feels that we could pull it off in time to have it added to our recertification audit. He feels that a technique called 'cut--and-paste' is the way to go. I've already taken a two-day class on the ISO update, and what he says makes sense to me."

Fran wasn't surprised that Mike had already prepared himself for the upgrade effort by contacting their consultant and taking courses, but she wasn't sure that the staff was ready so relatively soon after the last certification. She replied, "Mike, do me a favor, prepare a 30-minute briefing for the staff for Wednesday's ISO management review meeting and let's see how everyone feels about this."

Mike immediately assembled his notes and prepared for the review. He felt it was extremely important that Growth remain up to date in the quality arena, and the upgrade would be a effective marketing device—especially because so many companies were dragging their heels in this respect.

22.1.3 The Staff Meets

The Growth executive management team (GEMT) monthly management review meeting began on schedule and covered the usual items related to progress against quality objectives and the corrective and preventive action program. This took about 45 minutes. Fran then introduced the ISO 9001:2000 upgrade possibility and asked Mike to give his presentation. As soon as Mike started, everyone groaned, "Oh, not again!" It was not exactly good natured.

Mike explained that they would have to do it anyway in about a year, and why not save a few bucks on the certificates by doing it at the recertification audit. He pointed out that Sam had estimated the effort to take only four months and to not use up more than about 160 actual hours for the GEMT staff, or about 23 hours per person over the 4 months. This was because the company was already TQM-oriented, and the toughest section on quality objectives, metrics, and targets was already in place.

Most of this time would be spent on a rewrite of the quality manual. The ripple effect to the lower tier documents would be minimal and should require no more than another 160 hours of employee time.

At the moment, Mike couldn't see why it would take any more of an effort because the group already thought in terms of core competencies; the audit program was already process oriented; the corrective and preventive action program was already geared towards customer satisfaction; and management review meetings already included all of the prescriptive requirements of the new revision, and then some. Growth had also been blessed with several very competent third-party assessors, who had consistently fine tuned their QMS, and Growth had responded vigorously and successfully to half a dozen customer audits during the past three years. With respect to the 2000 version, the present QMS was hot cherry pie in the pan, cooking in a smoking kitchen!

The staff trusted Mike and had little comment, except that there wasn't a lot of time between now and the recertification audit, so they had better get started. Each staff member agreed to be process champions, as they had been before, and to select subprocess champions as required. Mike thanked the group, contacted Sam, and launched the cut-and-paste upgrade project.

22.1.4 The Upgrade Assessment

The upgrade effort proved to be highly successful. The assessors first examined the quality manual offsite. They had very few comments to make about the obvious conformance of the manual with the Standard. As a result, a preassessment was deemed unnecessary, and Mike decided on just going for the upgrade assessment about 30 days after he had received the offsite document review report from the lead assessor.

The upgrade certification assessment was carried out the day after the sixth surveillance was completed and went extremely well. The GCQMS was already in strict conformance with the Standard due to perceptive surveillance audits by the lead assessor and an intensive internal audit program. The three minor findings were really tune-up type observations (e.g., it was felt that the method of amendment to requests for proposals was not clearly stated). Mike took care of the nonconformance by adding a sentence to the manual (i.e., "The new sales orders are also required for RFP amendments"). The other two nonconformances had to do with quotes that are stored electronically but not clearly addressed and manufacturing capacity was not clearly addressed as a part of the quote process. Mike readily fixed those up, too. There were also a number of opportunities for improvement suggested by the assessor, and Mike promised to take them into consideration. Mike felt that each one had merit and included all of them into the GCQMS by the first surveillance assessment 6 months later.

At the closing meeting, the assessor was delighted to inform the company that the recommendation would be for upgrade to ISO 9001:2000. Growth could tell the world that they had been recommended for approval to the Standard. Approval by the registrar's main office would follow within 30 days. This was the assessor's tenth upgrade, and he hadn't lost one yet. Surprisingly, the executive team cheered out loud and then decided to hold a beer and pizza party that night. They weren't jaded after all.

We will now see how the team did the job. We begin the dynamics of the upgrade with some application notes.




ISO 9001(c) 2000 Quality Management System Design
ISO 9001: 2000 Quality Management System Design
ISBN: 1580535267
EAN: 2147483647
Year: 2003
Pages: 155

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