Featured Product
This Week in Quality Digest Live
Standards Features
Harish Jose
Using OC curves to generate reliability/confidence values
Phanish Puranam
Instead of blindly adopting industry best practice, companies can pilot new organizational designs
William A. Levinson
All is not gold that glitters
Grant Ramaley
IAF CertSearch now mandatory for accredited certification bodies
Megan Wallin-Kerth
MasterControl’s Matt Lowe talks competition, data, and what quality does for a company

More Features

Standards News
June 6, 2023, at 11:00 a.m. Eastern
Ensuring product consistency, quality, and adherence to federal and state standards
Omnex webinar on May 11, 2023
Digital Twin Consortium’s white paper guides strategies for building owners and stakeholders
Copper, titanium, and 304L stainless-steel powders from Desktop Metal have qualified for production
Webinars cover Automotive SPICE and carbon neutrality standards
Creates one of the most comprehensive regulatory SaaS platforms for the industry

More News

Denise Robitaille


Buy One, Get One

Cheap thrills

Published: Tuesday, August 8, 2006 - 22:00

Don’t you love it when you go to the store and they have a “BOGO” sale? BOGO, as in buy one, get one. Who can resist the attraction of being able to get two things for the price of one?

I once had a client who was going through the company’s registration assessment for ISO 9001. The client had individual forms for each production machine’s preventive maintenance (PM). The blank form included guidelines for the PM, so it was the document that defined the requirements. When it was filled out, it became the record (evidence) of fulfillment of the PM requirements. The registrar’s auditor turned multiple shades of red as I tried to explain that the blank form was a document and the completed form was a record. He was trying to convince my client that he needed to write a separate work instruction for each machine. The idea that one piece of paper could serve two purposes was a concept he just couldn’t quite grasp.

This illustrates one of the drawbacks of paying too much attention to the numbers of the standard, rather than the text that follows each number. We end up losing sight of the fact that one activity may fulfill multiple requirements of the standard, and we miss the chance to make the system more efficient and more meaningful to the people using it.

Let’s take a closer look at the requirement for continual improvement. ISO 9001 subclause 8.5.1 states: “The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.” The standard clearly directs the user to fulfill the continual improvement requirement through the fulfillment of other requirements. If you establish objectives, plan activities to achieve the objectives, allocate resources, measure the results and analyze progress, you have fulfilled the requirements for continual improvement. Along the way, you will have also addressed the requirements for subclauses 5.4.1 "Quality objectives," 5.4.2 “Quality management system planning," 5.6.3 (c) “Quality management review—resource needs," 8.2.3 “Monitoring and measurement processes“ and 8.4 “Analysis of data."

It’s possible to exploit this concept and use it to implement a cheap, barebones, minimally-compliant ISO standards system. However, without too much effort, it’s even more probable that you can develop a system that’s efficient, meaningful, transparent and profitable.

Again, using the continual improvement requirement, let’s apply a real- case scenario. The organization has established an objective of decreasing the cycle time for order fulfillment. This encompasses the time from when the order is received until it goes out the door. The current status is 16 days and top management has set an objective of 12 days. After the objective is established (subclause 5.4.1), plans are developed to meet the objective (subclause 5.4.2). Part of the plan may involve the automation of a tedious manual process. Once the plan is laid out, the resources—the new machines—that will be required are identified (subclause 5.6.3) and provided (subclause 6.2.1) to implement the plan. Implementation will include monitoring and gathering data about progress toward achieving the objective (subclause 8.2.3), which will be followed by an analysis of the data (subclause 8.4). If you’ve been able to get the cycle down from 16 days to 14, you have achieved 50 percent of the established objective and, therefore, experienced continual improvement (subclause 8.5.1).

Other examples might include a preventive action (subclause 8.5.3) to address a change in the company, like the acquisition of a new facility, that might involve the transfer of equipment and the reorganization of work spaces. Subclause 5.4.2 (b) requires that management “…ensure the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.” By identifying the potential problems that may arise from the acquisition and taking appropriate action, you can prevent delays, shutdowns or other nasty events. This will also allow you to maintain the integrity of your system. Another BOGO!

Document control (subclause 4.2.3) is one of the tools that you use to fulfill part of the requirement for internal communication (subclause 5.5.3) because it is how we communicate to others how things should be done. In some industries, identification and traceability of material (subclause 7.5.3) facilitates proper storage and handling (subclause 7.5.5).

The point is that one activity can have multiple aspects to it. Understanding those aspects makes it easier to comprehend interrelations and to discover opportunities for greater efficiency that can influence the bottom line.


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.