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Denise Robitaille


Pre-assessment at the North Pole

Quality control never takes a holiday.

Published: Tuesday, December 7, 2004 - 23:00

Good morning, everyone.

On behalf of Galactic Registrars Interstellar Network (GRIN), I’d like to express our appreciation to your organization for selecting us as your ISO 9001 registrar. Before we begin the audit, there are a few items we need to cover. This is standard auditing protocol. Certain things are required to be communicated during the opening meeting.

Would you please fill out the attendance sheet? Santa, I believe you told me that Mrs. Claus is the ISO management representative and that Master Elf Glifnix is the operations manager. If there will be no one else attending this meeting, we can continue.

GRIN doesn’t employ full-time auditors. I’m a sub-contractor. My credentials are on file with at the registrar’s corporate office and available for your review. I’m an RAB-certified lead assessor and an ASQ-certified quality auditor. I’ve more than 10 years of experience as an auditor and my field of expertise includes general manufacturing, machining and electronics. Although I also work as a consultant, my role as an auditor prevents me from consulting. I’ll be making observations, but I can’t offer any additional services that may be construed as consultancy, because that would be considered a conflict of interest and a breach of the auditor code of ethics.

I’ve also signed a nondisclosure agreement. This document ensures that anything is observed during the course of the audit won’t be divulged outside of this organization. Proprietary product information is secure, as are the client lists, which I understand, according to the information I garnered during the document review phase, are referred to as the “Naughty” and “Nice” lists. The audit report is held in strict confidence.

The purpose of this audit is a pre-assessment to determine your organization’s level of conformance to ISO 9001. The intent is to generate a report that will allow your company to address gaps and problems so that we can conduct a full audit next year, with the goal of registering the organization to the standard at that time. While the scope doesn’t include ISO 14001, you’ve indicated that you may wish to pursue that registration at a later date and have asked that any observations relating to that standard be included in the final audit report.

The scope of your certificate is the design, manufacture and delivery of Christmas toys and gifts. The name of the organization as it will appear on your certificate is “Santa’s Workshop,” which is located at Giant Clearing Beyond the Last Majestic Douglas Firs, North Pole. The number of employees is 6,837 elves and nine reindeer.

The pre-assessment will take two days, during which the various processes that collectively make up your quality management system will be assessed. It will be conducted wholly at this facility.

GRIN realizes that this time of year is particularly busy for your organization, with your major delivery period just around the corner. There are definite advantages to assessing Santa’s Workshop during the peak season. It’s in these volatile times of last minute changes, longer hours, final test of new designs and training of seasonal extras that we can see just how effective your QMS truly is in controlling your processes and ensuring customer satisfaction.

As I’ve already mentioned, I’ve done a preliminary review and assessment of your QMS documentation. What’s been developed appears to be adequate. However, the documents have raised some questions that I’ll be asking as I visit different areas. I’ll point out some of the areas of concern as we review the schedule. I fully understand the importance of meeting your delivery schedule. I’ll try to be minimally intrusive and not distract your staff needlessly. However, I’ll have to interview key personnel.

Audits and pre-assessments utilize four different kinds of information to determine conformance:

  • Documents that define the requirements and specifications
  • Records that provide evidence of fulfillment of requirements
  • Observation of process owners performing their functions
  • Interviews to demonstrate awareness and to further explain how requirements are fulfilled.

It’s through a combination of these four kinds of information that we can arrive at a determination of level of conformance.

The manner in which I conduct the audit will also allow me to assess if the organization demonstrates a commitment to the eight quality management principles: customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, factual approach to decision making and mutually beneficial supplier relations.

As this is a pre-assessment, there will be no requests for corrective action. In the event that nonconformances are observed during the course of the registration assessment next year, you’ll have a defined period of time to respond with a plan for corrective action. For this audit, all nonconformances will be expressed as observations and you have the option of deciding what action you will take. Note that taking no action will probably result in a finding of nonconformance later, and that will definitely require corrective action.

I’ll endeavor to explain the nonconformance to the process owner before I leave the area. Nonconformances will be summarized and further explanations offered, if needed, during the closing meeting. If you have any concerns or wish to appeal any findings made during the audit, you have the right to do so by contacting the GRIN’s home office.

I’ll require an escort with me at all times. This is for your protection and mine. That way you can be assured that I won’t wander into areas where I could come to harm and you can feel confident that I won’t blunder over something and damage any equipment or product. I’ll need safety glasses in the shop and the maintenance shed—and probably some boots in the reindeer area.

And now, to the schedule… I’d like to begin with top management interviews. We can take a look at what’s been done in establishing objectives, allocating resources, developing appropriate metrics for key processes and bringing consistency to the whole implementation of your quality management system.

Next, I’d like to take a look at your design area. You have a lot of mature designs, like the sleds and rocking horses that have only had minor modifications. That will allow me to assess how you control your design change processes, which includes controlling the product documentation and resulting manufacturing, equipment and training issues that might emerge. That will also give me a chance to see how you fulfill the requirements relative to ensuring that statutory and regulatory regulations are considered in design specifications. It seems that the regulations have gotten a lot more prescriptive and detailed in recent years. Have your processes kept up?

I see that you outsource the design and manufacture of some of the newer electronic toys. The ISO standard requires you to exercise appropriate control over the suppliers of those outsourced processes. I’ll be looking at how you qualify them and how you ensure the products these vendors deliver conform to your customers’ requirements.

You also outsource part of the process for gathering customer orders. You apparently use the postal service. I’ve to say that having a copy of Miracle on 34th Street and showing the dramatic courtroom scene when all the mail bags are delivered to you during the hearing, somehow provides little more than anecdotal evidence of qualification. I have an open mind, but I’ll be taking a closer look at that qualification process during the assessment.

Getting back on track, I’ll be looking at how you meet customer requirements. Your documentation seems to reflect that kids can order whatever they want, but you decide what they get. I must say I’m a little skeptical. It says in your procedure that the international consensus is that this is perfectly acceptable and in complete accordance with the universal rule of naughty or nice. The procedure goes on to mention parental intervention. I’m not saying that anything is wrong, only that I need to see if your process is adequately controlled and if it’s effective.

I’ll be spending quite a bit of time in the shop, since you have such an enormous array of toys that require thousands of specifications and multiple processes. At the same time, I’ll be checking out your production scheduling practices and your inventory system.

As part of the shop assessment, I’ll be looking at training programs. The training courses you have for the young elflings coming up through the ranks is pretty substantial. But I’d like to see how your refresher training sessions are working out. Once every 115 years seems a little long. I didn’t see mention of refresher sessions for the reindeer covered in the procedure.

I’ll be looking at the maintenance records for your sleigh and checking out any upgrades that have been installed. Then, I’ll be taking a look at the calibration records for your measuring instruments. I reviewed your list and don’t remember seeing a light meter for Rudolph’s nose.

I’d like to take a look at packaging last because I know that you’ve just started wrapping the gifts and putting them into pouches for loading on the sleigh.

This is just an overview. There are more details and a few other areas that are on the schedule. There, you’ll find incoming inspection, nonconforming material, preventive action and the like.

By the end of tomorrow, we should have a pretty good idea of the level of control in your quality management system. With any luck, I’ll have a positive report and be on my way—but not before wishing you and yours a Very Merry Christmas.


About The Author

Denise Robitaille’s picture

Denise Robitaille

Denise Robitaille is the author of thirteen books, including: ISO 9001:2015 Handbook for Small and Medium-Sized Businesses.

She is chair of PC302, the project committee responsible for the revision to ISO 19011, an active member of USTAG to ISO/TC 176 and technical expert on the working group that developed the current version of ISO 9004:2018. She has participated internationally in standards development for over 15 years. She is a globally recognized speaker and trainer. Denise is a Fellow of the American Society for Quality and an Exemplar Global certified lead assessor and an ASQ certified quality auditor.

As principal of Robitaille Associates, she has helped many companies achieve ISO 9001 registration and to improve their quality management systems. She has conducted training courses for thousands of individuals on such topics as auditing, corrective action, document control, root cause analysis, and implementing ISO 9001. Among Denise’s books are: 9 Keys to Successful Audits, The (Almost) Painless ISO 9001:2015 Transition and The Corrective Action Handbook. She is a frequent contributor to several quality periodicals.