Creating a Home Grown, Perennial, ISO 9001 Garden

Using Only ONE TOOL!


Have you ever sat in a meeting room constantly looking at your watch and counting the minutes left before the meeting ends? Were you listening to managers reporting production problems? Did you begin to daydream and wonder why, after 20 years of manufacturing similar products, you are still required to sit around a table to discuss the same issues that continually eat into profits and stunt growth? Did you ever conclude that there was no hope left, that nothing will work? No amount of changes, not ISO 9001, not a new quality manager, and certainly not more endless meetings!

Well, we can tell you that you are not alone and that right now, as you read this, thousands of managers around the world are sitting in wasteful endless meetings, counting their seconds, and daydreaming along with you.

Take heart! We were there ourselves many years ago.

That’s why we decided to change how we did business.

We (like many others) had read all about the horrors and ineffectiveness of ISO 9001. We read about hiring consultants, receiving newly created procedures said to be ISO 9001 compliant, and receiving implementation training. We read about how, in many instances, no real measurable change to product quality or service delivery was achieved. We also read the entire ISO 9001 standard, and we attended many training seminars.

At the end of this long, painful, and expensive learning curve, we realized that there was one element of ISO 9001 that stuck in our heads and continually came up for discussion. That topic was Corrective Action and Root Cause Analysis combined with Risk Analysis. The more we thought about ISO 9001, the more we realized that the ley to successful implementation was just plain common sense.

The problem was the implementation approach taken by too many organizations.

The classic and typical approach to implementation is:

  1. Find and hire consultants;
  2. Work with the consultants to create the documentation required to implement the standard;
  3. Work with the consultants to train personnel to follow the procedures;
  4. Review and audit your system as implemented to determine areas for improvement;
  5. Hire a registrar to audit and certify your organization as ISO 9001 compliant;
  6. Then run the business for six months and prepare for the registrar’s next maintenance audit.

Although this is a common approach, the long-term viability of the system does not seem to be worth the effort since we have heard from many organizations that five years after implementation they still find themselves sitting in meeting rooms endlessly discussing problems and challenges that never seem to go away. Adding to the pain is the cost associated with the ISO compliance project that further chews into the very profits that the program was implemented to preserve and enhance, along with constant process failures and breakdowns in communication.

As with scores of human frailties, the moment when we are able to admit the failures of our ISO 9001 project, is the moment when we can begin the cure.

The source of the difficulty is that too often the solutions were created before the problems occurred. In other words, the procedures and systems were created and written with an inbred bias of seeking to pass an eventual audit and to address perceived problems within the organization using the ISO 9001 model as a guideline, rather than the actual sources of pain. Furthermore, the procedures resulted from a top-down model: created by a select few often without sufficient input from key long-term players within the organization. The nail in the coffin is that becoming ISO 9001 compliant is usually a race against the clock with the project benchmarked against a schedule, a pre-set plan of actions, and pre-conceived milestones.

Consider a different approach.

Let’s take a moment to climb out of the ISO 9001 box and start thinking with a fresh mind.

The first question to ask is why seek ISO 9001 compliance? The best answer is to avoid sitting in endless meetings discussing failures. Most managers would prefer to sit in meetings to celebrate success and to decide how to allocate ever-increasing profits.

Should implementing a system be a race against time or should it be treated with patience and understanding so that it results in an effective system for all concerned (customers and suppliers included)?

This is where our approach and planning model differs significantly.

What would happen if every single person in the company were trained on two elements only? I mean fully trained! Not a thirty-minute seminar but real training serving as a foundation for your continuous improvement system.

We now refer to the quality management system simply as “the Improvement System” because that is what it should be. It should never be stagnant and should always be evolving and improving.  When we use the term Quality System, it tends to give us the impression that is a thing that we have and it is something in place. The kernel of the problem is the term itself that seems to indicate that the goal is to acquire a determinate Quality System that, once acquired and implemented, will accomplish the objective. That does not fit our goal of avoiding those endless meetings to discuss failures and problems.

From now on, we have a new path to success. The goal is to create and implement an Improvement System! With this new goal in mind, we now have something we can sink our teeth into. We have something small yet powerful! We have something that just might eliminate those endless meetings we dread. Now we have only one focus and that is real and sustainable improvement!

Isn’t it odd how a few words can change the game? We know that it is true. When we implement an improvement system, we train everyone in the company to manage the tools necessary to accomplish improvement in all processes. These tools are:

  1. Reporting known problems;
  2. Performing a risk and root cause analysis using a suite of tools such as a why-tree analysis or a fish-bone diagram;
  3. Containing the risk or problem at hand;
  4. Implementing an effective corrective (ultimately preventive) action; and
  5. Following-up on the corrective (ultimately preventive) action periodically to ensure its continued effectiveness.

When we implement the improvement system, we address actual problems within the organization and not perceived problems following the guidelines of the ISO 9001 model for quality assurance. Once an improvement system is implemented, in a short time, all required elements of ISO 9001 certification will have been addressed.

This is just a plain common sense approach.

Here are a few examples that demonstrate this new common sense approach:

Problem:                            

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

Root Cause Analysis:        

The organization does not have a system for document and data control.

Corrective Action:             

Create a system to control documents and specifications that ensures that all documents are current and that obsolete documents cannot be used.

Comment:                          

This is the beginning of addressing ISO 9001 Control of Documents.

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Problem:                            

Customer rejected the product for dimensional failure.

Root Cause Results:          

A Vernier calliper used in production inspection was worn and its accuracy was +/- 0.003” when it should have been +/- 0.001”. This happened because there was no system in place to periodically inspect the accuracy of instruments.  

Corrective Action:             

Create a system to inspect measurement instruments periodically to ensure that they always meet their standards for accuracy and that we have these results on hand to show the client when measurement accuracy is questioned in the future.

Comment:                          

This would be the beginning of ISO 9001 Control of Monitoring and Measurement Devices.

As you can see from this example, the longer we work with an Improvement System, the closer we get to achieving our objective of having implemented a system that will conform with the ISO 9001 standard. The real difference in execution is that:

  1. The solutions were created by existing personnel in a collaborative effort (home grown and bottom-up);
  2. The solutions address real problems that the team can get their hands around;
  3. Motivated personnel implement the solutions since they are solving their own problems;
  4. The solutions have a much better crack at success;
  5. The system is based on improvement; therefore it’s evolutionary, not revolutionary!

By implementing an improvement system we ensure that the process evolves and that it is never stagnant. We ensure that problems are always addressed, solved, that their solutions are effective, and that proper follow-up is performed on a continuing basis. This follow-up model is the foundation for ISO 9001 risk analysis and internal auditing.

We are confident that when an Improvement System is properly implemented in an organization 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 applying common sense.  There is no cause to worry about the dreaded ISO Audit or auditor. The objective is not to have happy auditors but rather to have a better company. The result may not be structured exactly like a classic ISO 9001 system since the staff may not have named the procedures in accordance with standard ISO 9001 terminology. They will have created procedures and named them using their own terminology that they understand. It’s important to understand that the new ISO 9001:2015 does not require a standard set of procedures and terminology and encourages organizations to create a system that best works for their own organization, a truly home-grown system! Certification becomes a formality and not a nerve-racking perpetual challenge.

A colleague of ours, 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 sent to brettakelly@cox.net. Bretta is a forward thinker and one of the smartest ISO 9001 consultants and ISO 9001 auditors that we have had the pleasure to meet!

To guarantee success in implementing your Improvement System you must train your employees and you must train them well on all risk analysis and problem-solving techniques. They must have access to external references and be able to discuss and acquire knowledge from their customers and suppliers.  

We have a story we would like to share about training.

Many years ago, we were consulting at a company. While we were there, the owner had brought his sixteen-year-old son into work on the Monday morning and introduced him to all of the personnel.  the owner explained to the operations manager that his son would be working during the summer months and simply said to the operations manager “could you please show him the ropes”.

We were there for the balance of the week and often ran into the owner’s son. We could not believe how well the training was progressing and how in-depth and complete the explanations were. The operations manager was not born yesterday and fully understood that one day in the near future, the owner’s son would be there full time and chances were that he would have to report to him.  We assumed that most of the other managers felt the same. It was for that reason that they trained the owner’s son completely so that he would understand everything when he would eventually take his position in executive management. They wanted to be certain that he understood the challenges and problems with the work on the shop floor because he might be the one making a huge difference in the future.

The son did eventually start in the business and the excellent training he received during those summer months helped him become President of the company and very successful. While we were witnessing the training it occurred to us that if they trained all new employees in the same way, expecting each one to be special and to make a difference in the future, what a difference it would make. It is hard to imagine such a company.

This simple story highlights how to train effectively with the right approach, attitude, and patience that motivates your personnel. The attitude of the trainers and the completeness of the training material is what makes the difference. That approach will be the difference between a highly successful improvement system and one that always seems to be an endless struggle.

In summary, using a single quality tool can help your organization become ISO 9001 certified, eliminate repetitive problems, and those annoying endless meetings.  We know this works because it worked for us. We got it right by creating an effective solution for our own consulting business. The solution to the problem was to have procedures and forms available electronically for all the employees to use. Our CIS Continuous Improvement Software helps consultants train your personnel and implement ISO 9001 faster and at a significantly lower cost.

Today CIS has surpassed all other ISO 9001/AS 9100 system requirements and offers a complete cross-platform improvement system that any organization can use to effectively to improve the management of their enterprise. We know from experience that our improvement system will continue to evolve and that CIS will continue to grow, offer more features, better solutions, and eventually, become the standard for continuous improvement worldwide.

One last note: We use the term perennial in the title because perennials come back year-after-year. While most other quality systems perform like annuals in your garden requiring re-planting season after season, our improvement system performs like a perennial because it is hardy, it is robust, and you only have to do the planting chore once, and it’s done!

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About the Author:  Peter Sanderson is a visionary leader pursuing a lifelong mission to provide state of‑the‑art enterprise resource planning solutions fully integrating production processes, enterprise level quality programs, internal controls, and finance and administration systems. Peter began his career in the defence and aerospace industries focused on quality assurance. He is a certified specialist in X-ray, magnetic particle, and liquid penetrant inspection and assessment. Peter Sanderson is the founder of TQMS Inc. and the creator and developer of CIS - Continuous Improvement Software.  Peter was recognized as the 2008 Professional of the Year by Quality Magazine.