I believe that there is a misconception among many people that procedures are the most important method of creating internal control.  Then lots of procedures are written - documenting process after process, whether for processes on the manufacturing floor or in the office (as the Sarbanes-Oxley Act requires for Financial and Accounting processes).

The problem is that poorly written and unused procedures provide very poor control, if any.  How can a procedure that few people know about, and even fewer people use, provide control?  It doesn’t.

However, well-written procedures that are also well communicated can be an important element in achieving consistent results (the typical goal of process control).  But it is not the only way, and procedures are really best if used in conjunction with other control methods.

What if, along with procedures (or even in lieu of procedures) you conduct thorough and regular training for those involved in the process (and create training records to provide evidence of the training).  And you also create SMART objectives for the process, and create records of key process results that align with the process objectives, along with visual tracking of results against objectives.

Wouldn’t proper training of personnel and tracking of actual process results against desired results (objectives) demonstrate control better than an unused procedure sitting in a drawer somewhere?

There is general agreement among Quality Managers and Quality Auditors that process auditing is more beneficial than clause based auditing.

In clause based auditing, an organization or a segment of an organization is audited to verify it complies with a particular clause of the ISO 9001 QMS Requirements.

With process auditing, a particular process or group of processes is audited to ensure that it complies with any part or clause of the standard that applies to it.

For example, corrective action is a clause in the standard, but corrective action should also be a continual improvement process.   If you are doing a clause based audit, you would audit aspects of corrective action that are covered in the corrective action clause (8.5.2).  If you are doing a process audit of corrective action, then you would verify that the corrective action process is in compliance with all applicable sections of the standard, not just clause 8.5.2.  It could include things such as Customer focus (5.2) and Customer satisfaction (8.2.1), Competence, training and awareness (6.2.2), Control of documents (4.2.3) and records (4.2.4), Analysis of data (8.4), and (definitely) Management review (5.6).

But effective process auditing requires a good grasp of the standard, so the auditor or audit team knows which clauses of the standard apply to a particular process.  While new auditors or a newly established QMS may start with clause based auditing, the goal should be to move to process auditing as soon as the auditors and the quality team feel familiar with the standard.

As the above example demonstrates, process auditing provides a much more comprehensive and in-depth measurement of the Quality Management System, and thereby provides better value for your internal auditing efforts.

If you hear that question from anyone other than a new employee or a novice in your organization, then you might have a quality system problem. People who execute processes should know whether or not a procedure exits for a process. The process experts (those who execute the process on a regular basis) should have a role in creating and/or maintaining procedures. Plus, they should have been trained, formally or informally, on the process and the procedure. They should know that they are executing the process according to the procedure.

Occasional process participants (i.e. the expert’s back-up, or for processes that are executed infrequently) should rely on procedures because they are not thoroughly familiar with the process. They should know about existing procedures as well.

If the process experts or even occasional users do not know about a procedure, the problem likely stems from several possible areas.

Poor Procedures: Perhaps the procedures themselves are too long, too confusing, too hard to use, poorly written, and perhaps even hopelessly inaccurate. Such procedures are typically ignored in organizations, and for good reason. Pretty soon they are forgotten relics.

Poor Communication: If training and auditing methods are inadequate, then there may not be enough awareness of procedures. Throughout the organization, training should explain why procedures are important, how to find them, how to change them if they are wrong, and what procedures are relevant to particular processes.

Poor Document Control: Without a good system to manage your documents so people can easily find procedures, retrieve them, etc.., then once again there is good change people will just ignore them. Procedures are supposed to help members of the organization, not add an additional bureaucratic maze.

So if you have a problem with your colleagues not knowing that procedures exists, or the existing procedures not being used in your organization, there is a good chance there is room for improvement in one or more of these areas.

There are occasionally stories in the quality world about ISO 9001 Registrars handing out ISO 9001 certificates, but who are not properly accredited.  Believe it or not, there are unscrupulous people and businesses that are willing to take advantage of those who have not done their homework.

As many of you know, ISO (the International Organization for Standardization) is not actually involved in granting ISO certifications.  ISO creates standards, they are not in the business of enforcing them.  Other organizations actually handle the process of granting ISO certification.

Worldwide, the International Accreditation Forum (IAF) is the organization that handles all the facets associated with granting ISO 9001 Certification.  The IAF works with national or regional bodies, which in turn accredit registration bodies that go out and audit organizations for compliance to the ISO 9001 standard.

Here in the U.S., the American National Standards Institute and the American Society of Quality cooperate to form the ANSI-ASQ National Accreditation Board, known as ANAB.  They accredit registration organizations, attempting to ensure consistency and compliance in ISO 9001 registration auditing.

Make sure you registrar is ANAB accredited

When you hire an ISO auditor for ISO 9001 certification, be sure to verify that they are accredited by ANAB or whatever the equivalent of ANAB is in your country or region (you can find a list of members at the IAF website, http://www.iaf.nu/).  And your registration certificate should have the ANAB and the IAF logos on it.  Without them, you are not truly ISO 9001 certified.

Make sure your ISO 9001 Certificate will have the IAF and ANAB seals

The Mississippi has been out of her banks frequently this year.  It finally receded a day or so ago (from the most recent above flood stage crest) so normal riverfront activity could resume.  Of course, downtown St. Louis is quite prepared for high water.  While a few streets and parking garages may be inundated, flood gates keep most downtown areas dry.

Then when the river returns to its banks, riverfront activity quickly returns to normal.

Being prepared for natural disasters is the key to coping and restoration should disaster strike.  In business, being prepared for disaster is the most important factor in whether your organization survives catastrophic damage by fire, flood, tornado, hurricane, or whatever Mother Nature throws at you.

If you are not prepared for natural disasters, you may be interested in our Disaster Recovery Policies, Procedures, and Forms.  Here, experts in the field will guide you step by step so that, should disaster strike, you can quickly get back to business.

I attended a juried art fair over the weekend.  As a juried fair, they select and limit the participants.  They try to focus on serious artists, and they ensure a variety of styles and mediums are included.

As I visited artist’s booths, I read many statements of vision that the artists had posted.  As you read the vision and then examine the works, it gives a stronger sense of meaning and purpose behind the works.  It also became more clear how the different and varied works by the artist were connected by a coherent theme.

A statement of vision in a business, or even a department, plays a similar role.  A clear vision statement describes a direction and purpose that the organization wants to achieve and fulfill.  The next step is to write policies and objectives that align with the vision statement.

Vision, policies, and objectives that are aligned and clearly communicated throughout the organization gives activities meaning and purpose, which in turns creates a positive atmosphere and culture.  It also becomes more apparent how all the various of activities are working toward reaching a common goal.

Do you have a statement of vision for your organization that gives meaning to what its members do on a daily basis?

In the current issue of the local restaurant and cooking magazine, the featured article is about the important relationships some of our city’s best chefs have with local farmers and growers.  In the half-dozen relationships profiled, rarely does the topic touch on price (and when price is mentioned, it focuses on the great value).  The emphasis is on other features:  freshness, taste, quality, variety, shared attitudes.

These chefs also know their customers.  The chefs understand that people come to their restaurant because they want a great dining experience, not because they want to save a dollar or two on a meal.  The chefs know the importance of having great local suppliers in order to deliver that great dining experience.

Any business that uses suppliers can take a lesson from this.  Too often business focus heavily on unit price from their suppliers, and they forget to focus on total cost, relationships, and even more importantly, how choosing suppliers impacts their customers.

Are you really saving money if you select a supplier based on unit cost, but shipments are late, parts are defective, or they require constant hand-holding to understand specifications or other criteria?  The union shop across town may not be able to compete with a third-world supplier on a unit price basis, but it you account for the total cost (i.e. of testing and dealing with defective materials, extra inventory or production delays because shipments are traveling  halfway around the world, the personal relationship and convenience of dealing with a local supplier), you may be saving money in the long run if the local supplier consistently delivers quality parts on time with little or no oversight.

Plus, if supplier problems causes you to lose a customer, how much have you really saved?

For those who work with processes, we know that variability is the key factor.  The desired state is more consistency and less variability.  When processes have wide variability and inconsistent results, we call the process out of control.  When processes operate within established limits, the process is considered in control.

Typically, we attribute process variability to two causes—common cause and special cause.  Common cause variation is expected.  It is a result of the process design, machinery, and activities.  For example, I walk to the train station every day after work, and it takes six to 10 minutes.  The variation is due to factors like how long I have to wait for the elevator, how many times the elevator stops, and how long I have to wait at crosswalk lights.  These variations occur every day, and they are expected.  They are common cause variations.

Then one day it took 12 minutes to walk to the train station.  It took longer because someone approached me on the sidewalk and asked for directions.  They were lost, so I took a few minutes to explain to them where they are and how to get to where they are going, plus exchange a few pleasantries.  But that doesn’t happen very often.  In fact, it hardly ever happens.  The next day I return to the six to 10 minute window for my walk to the station.  It was a special cause of variation.

When addressing variation in a process, you have to understand if the variation is due to common cause or special cause.  The type of variation determines the activities we need to take to reduce variation.

To reduce common cause variation, it usually takes experimentation and/or statistical analysis to optimize the process.  Experimentation means changing something and measuring the results over time.  Statistical analysis means looking at results in different ways—stratifying and categorizing data in diverse manners and employing varying statistical methods like Pareto charts.

For example, I might experiment and collect data and find that if I leave at 4:45 instead of 5:00, the elevators are much less busy, and variation in the time to reach the station is reduced.

Special cause variation is typically discovered using root cause analysis.  In my example it was easy to identify why it took extra time to reach the station, but frequently the cause of unexpected variation is not so easy to see.  It takes an investigation using quality tools like 5 whys or fishbone charts to understand what happened.  Then, you can take action to prevent the unexpected cause of variation or simply ignore it because you realize that it happens rarely and the consequences are acceptable (as in my example).  I don’t mind missing a train to help someone out.

I love teaching business training classes.  I tend to get engaged, intelligent participants who are eager to learn, willing to share, and with a desire to improve their organization.  Frequently, I get as much out of the experience as they do.

In a recent Well-Defined Processes class I had a particularly great group.  As usual, I came up with a very simple process example to illustrate concepts about processes.  In this case, I talked about baking a cake.

One participant really latched onto this concept, particularly in terms of writing procedures to document processes. “I am going to ask for cake recipes,” he said (in terms of developing procedures for his organization).  It is a great point.  Look at the back of cake mix box and see how effectively and efficiently it guides you through the process.

There is no unnecessary detail or descriptions of how to do things that you don’t need to be told how to do (like getting a mixer or turning it on).  There is no needless long-winded description of the chemical reactions that take place between the ingredients while mixing, and no explanation of the physical transformation that takes place while the cake is baking.  It has just a few simple steps with effective use of graphics that helps you properly execute the process.

Do you have too much information in your procedures?  To make your procedures usable, focus on the things people need to be told in order to execute the process, and leave out pointless directions and unnecessary explanations.

Sometimes when I say that phrase, “keeping with the spirit of the ISO 9001 standard,” I get long looks and contradictory comments.  After all, as we all know, with ISO 9001 auditing it’s all about specific criteria and objective evidence.  That does not align very well with the concept of the spirit of the standard, only the letter of the standard.

But consider this.  I have a friend who is an environmental engineer.  He complains that the most difficult aspect of his job is complying with long, tedious, arcane, and sometimes contradictory EPA regulations.  I sympathize with his difficulty; however, his mistake is to blame the extensive regulations on the EPA.  I argue that environmental regulations are so long and complex because every time a business and corporation exploits a loophole or missing detail, the regulation has to be revised to close the gap.  Do this for 50 years and obviously you end up with long, complex, and even contradictory regulations.

So, in my view, he shouldn’t blame the EPA for overly complex regulations; he should blame businesses, corporations, and environmental engineers who, instead of following the spirit of environmental regulations, sought to avoid compliance by exploiting loopholes, unspecific language, and missing details that have lead to this bureaucratic nightmare.

When it comes to the ISO 9001 requirements, the standard is brief and generic.  It is not full of details on what you have to do to comply.  This makes the standard very flexible so any type or size of organization can use it.  I feel this general nature of the standard makes it appropriate to talk about the “spirit” of the standard—the spirit of using a continually improving process approach to improve effectiveness and customer satisfaction.

In order to keep the standard brief and general, then organizations employing it (and auditors as well) have to keep in mind the spirit of improvement behind the standard and adhere to that, not only the literal letter of the standard.  After all, who wants to end up with an ISO Standard as difficult to navigate as EPA regulations?