Correcting a problem means correcting the process

Executive Summary: ISO 9001:2008 Corrective Action

The centerpiece for driving improvement in an ISO 9001:2008 quality management system is your corrective action process. While some companies appear to miss this critical point and seem to “go through the motions” of root cause and corrective action, many other organizations learn how to use corrective action to its fullest advantage.

When problems occur, either once or on a recurring basis, the root cause investigation starts with an understanding that nonconformities originate in a process that has failed. Processes that work well are those that follow four basic rules. When a process fails, then one (or more) of the rules have been broken and this broken rule is called the “root cause” of the problem.

An effective root cause and corrective action process for ISO 9001:2008 is then the investigation into the process that failed to determine the process rule that was broken and then determining the correct actions for corrective action. By addressing corrective action from the perspective of the process approach underlying the entire ISO 9001:2008 standard, long term solutions and better overall results are achievable.

This article presents a practical approach to root cause and corrective action you can use to transform your corrective action process into an effective tool for improved results for your organization and, ultimately, your customers.

Improved Results are None-Too-Common

improved-resultsIn addition to the marketing benefits of an ISO 9001:2008 certification, measureable improvement in results is a promise sought by nearly every company who implements an ISO-compliant quality management system. The ISO 9001:2008 standard itself promotes a “Process Approach” intended to improve “results of process performance and effectiveness” and “continual improvement of processes based on objective measurement” (see 0.2, ISO 9001:2008). The expectation is that ISO 9001:2008 will have a measurable return-on-investment (ROI) in terms of better efficiency and effectiveness, not merely satisfy customer requirements for a certification.

Unfortunately, better results are not always realized. Many managers who have “been through ISO” in the past have, through experience, found little payback from the huge effort put into preparing for and maintaining an ISO 9001:2008 certification. Too often, with the inordinate focus on writing endless documentation and scrambling to show auditors what they want to see, ISO is seen as an ancillary routine to the real business.

To these realists, the familiar adage “document what you do, and do what you document” represents the sum total of what they expect from an ISO effort.

This hardened perspective is reinforced by:

Issues recurring that were supposedly “fixed” in the past

Problems escaping to impact the customer that should have been caught

Company performance suffering due to mistakes that were “obvious”

Hard lessons learned being too often “forgotten” by the organization

… and all of this happening with an ISO certificate proudly hanging in the lobby of the building. Is this the best we can expect?

Those that Do vs. Those that Don’t

If you were to visit several companies with similar frustrating experiences as an objective outsider (as I have the privilege to do as an ISO consultant) you would begin to see a general pattern emerge that begins to explain, even predict, such disappointing results. You would find business owners and managers who genuinely care about the company and its customers. You would see leaders who react quickly to problems to minimize the impact on the customer. You would find them in endless meetings trying to understand what went wrong. You would observe them taking actions intended to stop problems from happening again in the future. And, too often, you would see the aggravation on their faces when the same problems recur despite the cost and effort expended to “solve” them in the past.

There are, however, a good percentage of ISO 9001:2008 certified companies that have a very different experience. While every company faces problems and challenges, some find ways to quickly learn from their errors and put lasting solutions in place. When they face an issue, they not only resolve the immediate concern and its impact, they have a way of digging into the “root” of the problem and changing things so that it is permanently fixed. Their investigations into problems are not haphazard, but systematic and rational. Measurable progress in improvement is seen in results that matter to the business and its customers. I personally know this to be true because I have had the privilege of working with many of these successful companies.

The interesting thing about companies at both extremes of the ISO spectrum is what they have in common:

Both have talented and experienced management

Both have committed and skilled employees

Both experience problems that have to be addressed

Both expend time, effort and money to address problems

Both have the same ISO certification

meetingThe difference is not in the problems they face, nor the effort they expend, but in HOW they respond to problems. It is in the way they investigate to find the reasons problems occur. It is in the conclusions they draw from those investigations. It is in the corrections they make to their processes to alleviate the source of the problems. It is in the follow-up actions they take to ensure problems are permanently resolved. Overall, it is in their perspective and understanding of the nature of recurring problems and how to effectively address them. So, what’s their secret?

The secret to an effective approach to correcting and preventing problems through a corrective action process is surprisingly more simple than expected. It doesn’t normally require big expenditures. It doesn’t often involve complex statistics and analysis. It doesn’t usually need complicated engineering solutions. The secret is found in gaining a simple understanding of what makes a process work well when it does – how things run smoothly when they do. Once you gain an understanding of what makes things work right, it becomes obvious what makes things go wrong.

Making a Process Work Right

A process is basically the way in which work gets done. It is a series of steps that have been planned to result, if followed consistently, in what was expected. Manufacturing has processes that result in products. Engineering has processes that result in designs. Purchasing has processes that result in quality products and services received. Sales has processes that result in new orders or contracts. Service companies have their own unique series of processes. All businesses and all parts of an organization have processes designed to produce results; and often individual processes are connected together in bigger processes to produce bigger results.

In order for any process to produce its intended results, it must follow a few basic rules:

The process must be defined by those who plan the work

The process must be understood by those who do the work

The process must be easy to carry out on the job

The process must be measured to understand its results

No matter what type of process in whatever kind of business, every process must follow these four rules to be effective. Break any of the rules and the process will fail. For example,

If a process isn’t defined clearly, it will be up to the individual worker how to get the job done; this means that the process will be done differently by different people.

If a process isn’t fully understood by each individual worker, it will result in individuals to develop their own understanding of the process based on “educated guesses” and “trial and error”.

If a process is difficult to follow because of various obstacles (problems with equipment, materials, schedules, instructions, etc.) workers will be forced to work “around the system” to get the job done; this will produce differing results.

If a process is not measured with reliable data, no one will really know how well results are being achieved and whether or not changes to the process should be made.

When a process is working well with good, predictable results, the four rules are being followed. Take a look at several well-running processes your organization and see if you can observe the four rules in action.

Finding the “Root Cause” of a Problem

finding-root-causeProblems occur when a process goes wrong. A “one time” problem results from a single breakdown of a process. A “recurring” problem comes from a process that consistently breaks one or more of the four rules. In either case, when trying to solve a problem so that it is permanently resolved, a few basic questions will guide you to an understanding of what’s wrong with the process that created the problem and, more importantly, what to do to correct it. In quality assurance lingo, this step in an ISO 9001:2008 corrective action process is called investigating the “root cause”.

Here are some investigative questions you can use to find the root cause of any process-related problem:

  1. Where is the process formally defined?
  2. Can those doing the work demonstrate complete understanding of the defined process?
  3. Are there obstacles in the process that prevent consistent adherence to the defined process?
  4. Do the measured results show the process capable of consistently meeting requirements?

These four simple questions are remarkably powerful in diagnosing the root cause of a problem. When using the questions, keep two general guidelines in mind. First, asking the four questions presupposes that you know which process originates the problem. In most problem-solving situations, there is a single process that has failed and has led to the problem. Be aware that because processes are linked, a problem seen “downstream” at the end of a series of processes may have resulted from a breakdown “upstream” at a previous process. Asking “why?” several times will help guide you to the original process that failed. Secondly, the four questions must be asked in order. For example, it is meaningless to ask workers to demonstrate their understanding (question 2) of a process that is not defined (question 1). Any reliable process first must be defined which means that it is documented, at least at a basic level. If then the process is defined and documented, checking understanding is based on specific requirements for the process, rather than the individual experiences and opinions of various workers. Likewise, looking for obstacles in the process that cause people to “work around” the official process (question 3) is futile if they first cannot demonstrate understanding of the process (question 2).

This methodology for investigating the real reason behind a problem brings us to a definition of the “root cause”:

The root cause of a problem is the weakness in the process that originates the problem.

There are, therefore, four possible “root causes” to any problem:

  1. Inadequate definition of the process.
  2. Inadequate understanding of the process.
  3. Obstacles in the process leading to “mistakes” or “shortcuts”.
  4. Incapable process as shown by measurable data.

Accurately identifying the weakness (using the four questions) in the failed process is fundamental to determining the right corrective action to take to prevent the problem from recurring.

Corrective Action is as Easy as 1, 2, 3 … 4

As critical it is to find the root cause of a problem, it is useless if action is not taken to correct the process. Fortunately, the four questions not only guide the investigation of the cause, they also direct us to the right corrective action. What a waste it is when a problem is well understood and the root cause is identified yet the effectual action is not taken, much like running a 1-mile race and stopping 100 yards from the finish line. Corrective actions become clear based on which of the four questions reveal the root cause:

  1. If the process is not defined adequately, create or update necessary documentation.
  2. If the process is not fully understood, provide training.
  3. If the process has obstacles, identify and remove them.
  4. If, after addressing 1-3 above, the process measures show the process incapable of meeting requirements, re-design the process (then ask questions 1-3 again).

The result is that companies that learn how to effectively resolve problems find the investment in ISO 9001 certification provides a foundation for future success. Care and diligence in the process corrective action drives the improvement in business processes that impact their customers and their own bottom line.