Creating a Home-Grown Perennial ISO 9001 Garden

Have you ever sat in a meeting room continually looking at your watch and counting the minutes left before the meeting ends? Have you wondered why—after 20 years of manufacturing similar products—you’re still discussing the same issues that reduce your profits and stunt your growth? Did you conclude that there’s no hope left and that no change will work—not ISO 9001, not a new quality manager, and certainly not more meetings?

You aren’t alone—thousands of managers around the world are counting their own minutes and daydreaming with you. In fact, my colleagues and I were there ourselves many years ago. That’s why we decided to make a change in how we do business. Like many others, we had read all about the horrors and ineffectiveness of ISO 9001. We read about hiring consultants and receiving newly created procedures in conformance with ISO 9001 and then receiving implementation training. We read about how in many instances no measurable change to the product quality or delivery was achieved. We read the entire ISO 9001 standard and attended many seminars.

At the end of this learning curve, there was one element of ISO 9001 that stuck in our heads and continually came up for discussion—corrective action and root cause analysis combined with preventive action. The more we thought about ISO 9001, the more we realized that it was just plain common sense. The problems are in the implementation of the standard and in many organizations’ approach:

• Choose and hire consultants
• Work with the consultants to create the documentation required
• Work with the consultants to teach the employees  how to follow the procedures
• Review and audit your implemented system to determine areas for improvement
• Hire a registrar to audit and certify your organization to ISO 9001
• Then, business as normal for the next six months until you prepare for the registrar’s next maintenance audit

Although this is a common approach, the long-term viability of the system doesn’t seem to be worth the effort because we have heard from many organizations that after five years they’re still sitting in meeting rooms to discuss problems and challenges that never seem to go away. Furthermore, many feel that the cost associated with the ISO 9001 project was just another expense that reduces profits, along with the constant process failures and breakdowns in communication.

I believe that when we can admit the failures of our ISO 9001 project we can begin to solve the mystery.

In our opinion, what went wrong is that the solutions were created before the problems occurred. In other words, the procedures and systems were created and written with a bias for passing an audit and to address organizational problems using the ISO 9001 model as a guideline. Furthermore, the procedures were created by a select few and they didn’t generally include input from key long-term players within the organization. Finally, becoming ISO 9001-certified is usually a race against time, and the project is usually benchmarked with a schedule and a preset plan of actions.

First, consider a different approach. Let’s climb out of the ISO 9001 box and start thinking with a fresh mind. The first question to ask is, “Why do we want to become ISO 9001?” The best answer is “To avoid repeatedly sitting in meetings discussing failures. Most managers would prefer to sit in meetings discussing successes and deciding how to spend the money.

Second, decide if implementing a system should be a race against time or if it should be treated with patience and understanding, so that it results in an effective system for all concerned, including customers and suppliers.

Finally, an approach and a plan must be created, and this is where we differ. What would happen if every person in the company was thoroughly trained on only one element? Not a 30-minute seminar but real training that will be the foundation for your improvement system. I will now refer to the quality management system as “the improvement system” because that is what it should be. It should never be stagnant and should always be improving.  When we use the term “quality system,” it tends to give us the impression that we have it, that it is something in place. The term seems to indicate that the goal is to acquire the quality system, and once it’s acquired we have accomplished our goal. That doesn’t seem to fit our real goal of avoiding those regular meetings to discuss failures and problems.

So from now on, we should have a new goal—to create and implement an improvement system. With this goal in mind, we have something small yet powerful to sink our teeth into, something that might eliminate those meetings we dread. Now we have one focus—improvement.

It’s funny how one word can change the game. If we were to implement an improvement system, then we would be required to train everyone in the company on the tools necessary to accomplish improvement in all processes. These tools would be:

• Reporting problems
• Performing a root-cause analysis using one of many tools, such as a why-tree analysis
• Containing the problem at hand
• Implementing an effective corrective action
• Periodic follow-up on the corrective action to ensure continued effectiveness

When we implement an improvement system, we address actual problems within the organization and not perceived problems following the guidelines of the ISO 9001 model for quality assurance. In fact, after implementing an improvement system, I believe that in a short time all elements of ISO 9001 will be addressed. Again, this is just common sense. Below are a few examples that demonstrate this approach:

Problem: Manufacturing worked with an obsolete specification that resulted in product rejection by the client:

Root cause: The organization doesn’t have a system for document and data control.

Corrective action: Create a system and specifications that ensure that all documents are current and that obsolete documents cannot be used.

Comment: This would be the beginning of addressing ISO 9001 subclause 4.2.3 – control of documents.

============================

Problem: Customer rejected product for dimensional failure.

Root cause: A vernier calliper used by inspection was worn—its accuracy was ± 0.003 in. when it should be ± 0.001 in. There was no system in place that would periodically inspect the accuracy of the instruments.

Corrective action: Create a system to periodically inspect measurement instruments to ensure that they are always meeting their standards for accuracy and that we have these results to show the client when measurement accuracy is questioned.

Comment This would be the beginning of ISO 9001 subclause 7.6 – Control of Monitoring and Measurement Devices.

As you can see from the above examples, the longer we work with an improvement system, the closer we get to achieving our objective and a system that would eventually conform with the ISO 9001 standard. The real difference is that:

• The solutions were created by existing personnel in a collaborated effort (home grown)
• The solutions were to address real problems that people can put their hands around
• Motivated personnel implemented the solutions, since they were solving their own problems
• The solutions will have a better chance to succeed
• The system is based on improvement, so there is no ending point

By implementing an improvement system, we ensure that the system continues and is never stagnant. We ensure that problems are always solved effectively and that proper follow-up is performed continually. This follow-up forms the foundation for ISO 9001 subclause 8.2.2—Internal Audit.

I’m certain that when an improvement system is properly entrenched in an organization that it will always result in a system that conforms to the ISO 9001 standard, because the standard is common sense and the solutions to problems are always a result of common sense. We should never worry about the dreaded ISO audit or auditor. The objective isn’t to have happy auditors but rather have a better company. The result may not be structured exactly like an ISO 9001 system since they may not have named the procedures in accordance with the standard ISO 9001 terminology. However, they will have created procedures and named them using their own terminology. Furthermore, once the improvement system has matured, a simple matrix can be created to cross-reference the ISO 9001 subclauses with that of their homegrown system that works. Any missing loose ends would be quick fixes, and at that point certification would be a formality and not a nerve-racking challenge.

A colleague of mine, Bretta Kelly, has written an excellent article titled “ISO is not Rocket Science” that should be read before starting any new ISO 9001 project. A copy of her article may be requested by e-mail at bretta@cissoftware.com.

To guarantee success in implementing your improvement system you must train employees well in all problem-solving techniques. They must have access to external references and be able to discuss and acquire knowledge from their customers and suppliers. I have a story I would like to share about training.

While I was consulting at a company years ago the owner brought his 16-year-old son into work and introduced him to all of the staff.  He explained to the operations manager that his son would be working during the summer and said to the operations manager, “Could you please show him the ropes?”

I was there for the balance of the week and often ran into the owner’s son. I couldn’t believe how well the training was proceeding and how in-depth and complete the explanations were. The operations manager understood that one day the owner’s son would be there full time and chances are that he would have to report to him. I also assume that most other managers felt the same, and that was why they trained the owner’s son so that he would understand everything when he eventually took his position in executive management. They wanted to be certain that he understood the challenges and problems with the work on the floor so that he could make a huge difference in the future.

The son eventually started in the business, and the excellent training that he had received during those summer months helped him become president of the company and very successful. What if they trained all new employees in the same manner, expecting each one to be special and make a difference in the future? It’s hard to imagine such a company.

We’re capable of training properly with the required attitude and patience when we're motivated. It’s the attitude of the trainers and the completeness of the training material that make the difference between a successful improvement system and a failure.

About The Author