Figure 1. PDCA Wheel

PDCA was developed by Dr. Walter Shewhart, one of the top ten quality gurus.  Dr. W. Edwards Deming preferred to call it PDSA or Plan, Do, Study, Act because he felt that “check” emphasized inspection over analysis.  Most people spend most of their time on the first two, Plan and Do, and tend to neglect the Check and Act parts.  An ISO 9001 QMS is a balanced system and to keep your ISO system working effectively you need to value each PDCA element equally and not favor one (i.e. Plan, Do) over the other (Check, Act).

We have written a lot about PDCA in the past.  Now let’s take a look at PDCA as it relates to ISO 9001 by breaking down the ISO 9001 standard into its main elements and then assigning them to each part of the PDCA process.  What you see is that each clause of the ISO 9001 standard contains a planning step, clause 7 is focused on doing, and clause 8 is focused on checking and acting.  What clause do you think people have the most trouble with?

Clause 8 is the most troublesome because it is focused on checking and acting.  People get more satisfaction in planning and doing then they do in checking and acting.  It is just human nature.  So, to master ISO 9001 you have to break the habit and budget more time for the checking and acting steps of clause 8.  Now let’s take a look at each PDCA element and see how ISO 9001 aligns with PDCA.

PLAN

Your business should have an annual planning cycle that produces business plans that contain your: vision/mission/quality policy, operational objectives, budgets, preventive maintenance/actions, document standards, milestones, and new product/market/process introductions.  These are all planning elements.  ISO 9001 calls out these planning elements in seven areas.  Maintain QMS (4.1)

• Document QMS (4.2)
• Management Responsibilities (5)
• Manage Resources (6)
• Plan Product Realization (7.1)
• Control Monitor & Measurement Equipment (7.6)
• Preventive Action (8.5.3)

Most of these obviously belong here but what about Preventive Action (8.5.3)?  It comes from clause 8 (a check act clause) and sounds like an action step.  I put it here because preventive action is a plan to eliminate a defect that has not occurred.  Since we do not know if it will ever occur (with or without the preventive action being taken) then it sounds like a well intentioned plan.  If the defect occurs then the plan failed.  If it does not occur, then is this because we took action to prevent it?  If we cannot say this with certainty, then I would call it a plan.

DO

Your do steps are more frequent, possible occurring on a monthly cycle that produces data records for measurement and analysis as a result of executing the annual plans. A lot of your doing is focused on clause 7, Product Realization. Most of your ISO records are produced in clause 7.

• Competence & Training (6.2.2)
• Design, Develop, Realize (7)
• Purchasing (7.4)
• Product & Service Provisions (7.5)

CHECK

Once you have data from your doing steps you need to analyze or study the data (remember Deming’s PDSA reminding us to Plan, Do, Study, Act).  We do not want to check to see if a step was done or check to see if data was produced.  This is nothing but inspection.  We need to analyze and understand what the data is telling us.  We do this by converting the data into information.

The ISO 9001 standard clearly defines various check processes, which are cycles of measurement and analysis to determine how well the organization is executing the annual plans.

• Management Reviews (5.6)
• Monitor & Measuring (8.2)
• Customer Satisfaction (8.2.1)
• Internal Auditing (8.2.2)
• Data Analysis (8.4)

These are not one-time events.  These check processes continuously occur, which brings to mind trend lines on charts as a way to convert data into information.

A monthly or quarterly check event is very realistic, although many companies choose an annual audit, management review or customer satisfaction survey as a sufficient check on the ISO 9001 QMS.  I guess if you have an incredibly stable business model with little to no competition and a static environment, industry or market then maybe you can get away with an annual check.  Are there any businesses like that anymore?

ACT

Actions taken — without undue delay– to close the gap, identified during measurement and analysis, between the annual plans and the data records produced during execution.   Of course there is an element of act in the management reviews because after you review the required inputs you are supposed to assign action items to individuals to take the necessary corrective actions (and maybe preventive actions).

ISO 9001 has a few clear action steps like isolating nonconforming product, taking corrective action, and maybe preventive action too.

• Nonconforming Product (8.3)
• Corrective Action (8.5.2)
• Preventive Action (8.5.3)?  ( I know some of you want this here)

ISO 9001 is not a single PDCA cycle.  It is actually a series of imbedded PDCA cycles.  Clause 7 is not just about doing.  Product realization is itself a PDCA cycle that starts with planning requirements and realization needs.  Next comes development (doing), development reviews (checking), and finally development revisions (actions).  This same PDCA cycle is occurring within training, documentation, purchasing, auditing, corrective action, etc.  The whole concept of continuous improvement relies on PDCA.

Check out Bizmanualz Internal Auditor Training programs for more information on building Lean ISO Quality systems, creating well-defined processes, or getting more value out of your quality management system.

Required Policies Procedures

Only company policies and procedures required by standards, regulations or company strategy must be developed.  ISO 9001 requires only six procedures, so why do many companies feel they need to write 40 or more procedures to achieve control?  Occasional users need procedures as a reminder of procedure steps that they do not perform very often.  Frequent or regular users do not need, and often times do not use, the procedure.  So how are those other 34-plus procedures used?  Most procedures are used to train infrequent users.  For training purposes you may only need a process map.  Are you using your procedures to make up for a weak training program?

Your Policies Procedures Template Design

When you do write procedures you will need to standardize on a procedure template design.  Start your policies and procedures template design by thinking through your document and record control procedures.  Your procedure template design should make room for a header block to ensure your procedure communicates your purpose and scope.

Add a Title, Policy, Purpose, Scope, Responsibility, and Definitions section to help people understand your procedure. Clear department responsibilities identify who does what and helps to declare which positions are mentioned in your procedure with a synopsis of what is expected for each position. Key term definitions reduce confusion; industry jargon should be explained in the definitions section of your procedure to help new procedure users.

Writing Policies Procedures

Before you start writing procedures from scratch, look around for examples, or templates, that you can copy.  Pre-written procedures will speed up your development, reduce your research time, and turn writing procedures into editing procedures.  I’ve found it’s a lot easier to edit a procedure than to write one from scratch, depending on the procedure.  Many procedures are really common using business best practices, so why reinvent the wheel?

If you have to write a procedure from scratch, start writing procedures using active voice construction to reduce task confusion. Subject, verb, object provides clear active voice construction for your procedure.  For example, “Accounts Receivable invoices customers” is clearer and contains fewer words than “customers are invoiced by Accounts Receivable.”  The extra “are” and “by” make the sentence longer, put the subject last, and force the reader to stop and reread the action.  Be direct and to the point — use the active voice.

Add references to related documents to improve your procedures’ usability.  Clearly note when your procedure refers to other procedures or forms.  There’s nothing worse than following a procedure and coming to a passage that refers to a company form and…that’s it. You don’t know what the form looks like, where you might find it, or what version of the form you need.  Putting an example of the form, with an explanation, in the procedure will save you and your users time during procedure training and implementation.

List applicable laws or regulations: clearly communicate your company’s need for compliance.  If you’re implementing a records retention procedure, references to IRS or equal employment opportunity (EEO) passages, for example, provide a brief synopsis and help you implement your procedures.

How to Write Policies and Procedures

Policies Procedures Overhead

Large organizations have a large number of procedures.  They have a lot of staff, business operations, and economy of scale to make their procedures work.  Smaller businesses should remember — the more business procedures you write, the more business procedures you have to edit, implement, train, audit, and review.  More procedures may also produce more audit findings in addition to more updates, more documents to control, and more administration overhead.

Many companies fail to plan for this administration and procedure overhead, so it should come as no surprise that their procedures don’t work as well as expected.  Every procedure becomes outdated, eventually.  Also, due to infrequent maintenance and use, some procedures are overlooked when it’s time to update them.  This can result in repeated procedure audit findings or, worse, repeated waste, fraud, and abuse which the procedures were intended to reduce.

The lean thinking solution is (a) to write only procedures that you absolutely have to write to conform to requirements and (b) to improve your training program to build competent and skilled employees instead of writing procedures you don’t have the time or budget to maintain.

Next week, we’ll cover policies and procedures implementation and training.  It’s much easier to comply with standards and train employees when you’re working with written procedures.  If you’re interested in learning more about your procedures, call or e-mail us for a procedure review of your written procedures.  We’re happy to provide feedback on what you’re using and tell you how you can improve your processes.

St. Louis, MO – June 18, 2009 – Bizmanualz, Inc., a business publications, training, and consulting company based in St. Louis, MO, today announced the release of the updated ISO 9001 Policies and Procedures Manual. The company has greatly improved its product by modeling its policies and procedures on the Deming (“Plan-Do-Check-Act”) Cycle.

“The updated manual reflects our lean philosophy in multiple ways,” said Christopher Anderson, Managing Director of Bizmanualz. “For example, rather than borrow the text of the standard verbatim in the quality manual, we stripped it to the bare essentials. Putting in a lot of verbiage not required by the standard can make your Quality Manual less user-friendly, less useful, and less likely to be improved.”

The updated ISO 9001 Policies, Procedures & Forms Manual conforms to the ISO 9001:2008 standard, which was updated for the first time in eight years and released in November, 2008. ISO 9001 requirements for procedures and records are clearly identified throughout the updated manual. Recently ISO 9001 certified by using lean principles, the company has used a similar approach in the update process.

“We carried procedures over (from the old to the new ISO 9001 QMS manual) that most organizations consider critical,” said Steve Flick, Bizmanualz Product Director. “Similarly, we removed procedures that customers didn’t consider a high priority, or had little-to-nothing to do with 9001 requirements, or didn’t amount to more than simple work instructions.”

Twenty-three QMS procedures are included in the updated ISO 9001 manual. A forms list at the end of each procedure points out if the filled out form is a “required record” and which ISO 9001 clause requires that record. Bizmanualz redesigned its ISO 9001 QMS manual to help companies easily establish an effective quality management system, as well as to simplify the certification journey for organizations wishing to comply with ISO 9001:2008.

Bizmanualz also offers manuals for Accounting, Finance, Computers & Networks, Sales & Marketing, Human Resources, ISO 22000, Disaster Recovery, and Security. All of Bizmanualz® Policies & Procedures manuals are available via instant download or in hard copy form, with easily editable MS-Word documents included on CD.

Each manual provides prewritten policies, procedures, and forms that enable executives to create and maintain internal controls and implement best practices for all departments in their business.

Bizmanualz® ISO 9001 QMS Policies, Procedures, and Forms: How to Quickly Create an ISO 9001 Quality Management System with easily editable Policies, Procedures, and Forms. (400 pp/trade binder/$495.00) is a Knowledge Management title from Bizmanualz, Inc. It is available through the company’s website, www.bizmanualz.com, or by calling the publisher at 800-466-9953 (outside the USA, call 314-863-5079), faxing your request to 314-863-6571, or by e-mailing sales@bizmanualz.com.

St. Louis, MO (April 24, 2009) - Bizmanualz, Inc., a business strategy consulting and quality publishing company based in Clayton, Missouri, today announced the successful certification to ISO 9001:2008 for the design, development, realization, and delivery of its policy and procedure publications, training courses, and consulting services.  The certification demonstrates the Bizmanualz commitment to continually improve its ability to assist business owners achieve the growth they envision. 

“We developed a Lean visual management approach to implementing our Quality Management System (QMS) to dispel the notion that an ISO system requires a lot of paperwork,” explained Chris Anderson, Bizmanualz, Inc., Managing Director. “Now we can show clients the benefits of a working ISO-compliant quality system using Lean visual techniques to streamline the operations, focus employees on the objectives, and reduce wasted efforts.”

Bizmanualz ISO 9001:2008 Registration

Bizmanualz received its ISO 9001:2008 certification on April 10,2009, from Platinum Registration.  Auditor Colin Gray noted particular areas of excellence, including Bizmanualz customer feedback, corrective action, and internal communication methods, which involve morning staff meetings around the company’s “scoreboard” — a bulletin board listing the company’s main processes, projects, action items, and metrics.  Mr. Gray also praised the Bizmanualz Internal Audit process, saying in his report that the company’s internal audits are “thorough, effective, and meaningful.”

Kaizens/Corrective Actions are posted on the Bizmanualz "Kaizen Wall"

With the new lean implementation, Dan Davison, Vice President of Sales and Marketing has noticed a difference, saying, “clients are seeing tighter project definition, project management, status reports, and budget forecasts by job for the coming weeks. Tracking tasks posted on the wall increase our communication’s effectiveness.”

ISO 9001:2008 is an internationally recognized QMS standard, which ISO Secretary General Rob Steele said has “an estimated one million users worldwide.”  Certification is obtained through independent registrars that audit every aspect of a company’s QMS.  Lean is a quality system approach that seeks improvement through the elimination of waste, a focus on the customer, and systems of visual management.

Bizmanualz has been at the forefront of deploying business best practices since 1995, delivering Policies and Procedures publications, Lean ISO Quality Management Systems, and strategic marketing implementation services to help business owners achieve growth and expansion.

Bizmanualz Policies and Procedures publications are available through Amazon.com, calling Bizmanualz at 800-466-9953 (outside the USA, 314-863-5079), faxing your request to 314-863-6571, e-mailing sales@Bizmanualz.com, or by logging onto store.bizmanualz.com.  Bizmanualz® is a registered trademark of Bizmanualz, Inc.

Management Commitment is Vital to ISO 9001 Success

Now we are starting phase three: implementing the requirements of Clause 5 – Management Responsibility and Clause 6 – Resource Management. While there are a number of required documents we created to meet requirements from Clauses 4 and 8, Clauses 5 and 6 are long on stated requirements (“Top Management shall … ,” “The organization shall … “), but they have few required documents and records.

In Clause 5, the responsibilities of meeting the requirements of the ISO 9001 QMS are put squarely on the shoulders of top management. Those who are familiar with how organizations tend to function know that the success or failure of any organizational endeavor depends on the commitment of top management. If top management does not see it as important or a priority, then it becomes starved for resources and eventually dies. Whatever top management focuses on, however, becomes a priority for the whole organization. This is certainly true for implementing, maintaining, and improving the ISO QMS.

There are specific requirements relating to Management Review in Clause 5, including a management review meeting record. Otherwise, there are no specific requirements to create particular records showing management’s commitment and responsibility. The requirement is a general one of providing evidence of commitment.

ISO 9001 Is Generic Application Depends on the Organization

It is this type of general requirement that many organizations struggle with. In contrast with specific requirements that are straightforward (for example, an Internal Audit procedure that includes responsibilities and requirements for planning and conducting internal audits, establishing records and reporting results), these more general “shall statements” require organizations to come up with their own method of compliance.

One way to deal with these less specific requirements is to convert “shall statements” into questions. For example, top management has to answer the question, “How do we ensure appropriate communication processes are established and that communication takes place regarding the effectiveness of the QMS?” The formal language in the standard seems intimidating and adds to the difficulty. Appropriate communication processes? But most organizations have communication processes; it is just a matter of recognizing them and being aware that those activities meet a requirement of the ISO 9001 standard. For example, perhaps you have monthly department head meetings, and departments have weekly staff meetings. Perhaps you have an on-line or printed quality newsletter. These are all communication processes.

Focus on ISO Compliance Not Unnecessary ISO Documentation

So in a sense, phase three is about reviewing and considering requirements in Clause 5 and Clause 6, and then recognizing how your organization meets them. You don’t have to have procedures or even records in order to comply, unless you feel they are important for the needs of your organization. Obviously, as you work through this, when you recognize a weakness or an area of non-compliance it is time to implement new or altered methods. But as in our communication example, frequently organizations are doing things that comply with the requirements. It is just a matter of being cognizant of them, plus knowing what evidence exists that verifies your compliance.

Clause 6, Resource Management, requires a similar approach. Phrase the “shall statements” as questions and then give reflective responses. For Clause 5 and 6 you may want to capture these responses in notes for your own purposes or for training, but there is no requirement to do so. In terms of compliance, just be sure you can answer the question appropriately when the internal or external auditor asks, and that others give answers that are consistent with your compliance methods. Be aware, however, that after you give an auditor the answer, he or she will then seek objective evidence that you do, indeed, do things that way (such as meeting agendas, minutes, or collaboration from the earlier communication example).

Training Records Are Required in ISO 9001

Let’s emphasize, however, the training record requirement for Clause 6 of the ISO 9001 QMS Requirements. Many auditors agree that this is a common area of weakness among ISO 9001 certified organizations. So one focus for phase three of ISO 9001 QMS implementation should be creating a training record system where education, training, skills, and experience are captured. In larger organizations this probably has to be handled at the department level, but there should still be consistency throughout the organization. This will require a systematic approach that is communicated through training, examples, etc., to department leaders.

So there is no simple advice or direct methods for complying with the requirements found in Clause 5 and Clause 6. Phase three is as much about understanding and awareness as it is about creating new processes and documentation. Each and every organization has to decide how they currently fulfill them or how they will fulfill them. It is this flexibility, however, that makes ISO 9001 flexible enough to be applied to any type of organization.

Our next and final piece in the series will cover phase 4, implementing ISO 9001 Clause 7 – Product Realization, also known as design, development and fulfillment. Here the ISO 9001 Requirements are heavy on records that many organizations have difficulty with in terms of compliance. We will discuss ways to simplify and streamline Clause 7 compliance.

• Become familiar with the ISO 9001 QMS Requirements
• Identify key QMS processes and their interaction
• Create drafts of the Quality Manual, Quality Policy, and Policy Objectives
• Write a draft of Document and Record Control Procedures

After completing these tasks (delineated in Clause 4 of the ISO 9001 Standard), the next crucial step in implementing an ISO 9001 QMS is to create the continual improvement processes as described in Clause 8 of the standard. In terms of Clause 8 continual improvement primarily consists of Customer Satisfaction, Internal Auditing, and Corrective Action, and Preventive Action.

Sketch Out the Continual Improvement ISO Processes

After putting the basic components of the general QMS requirements in place during phase 1, in phase 2 the focus is on continual improvement because it is the continual improvement processes of the ISO QMS that provides value and benefit to your organization. So, in order to gain these benefits as soon as possible, start putting these processes in place and practicing them.

Much as was described for the critical QMS processes in phase one, sketch out your continual improvement processes. Ask questions such as: How will using Corrective Actions and Preventive Actions (CAPA) most benefit the organization? Who are the process owners? What are inputs and outputs? Are certain departments integral to CAPA or should everyone get into the act? Of course, when resolving such questions, it is a good idea to involve the ISO Strategy Team. They can provide perspectives from various departments or segments of the organization.

Drafting the ISO 9001 Procedures

Once you have a continual improvement process sketched out, write a draft procedure. Remember, it is better to document a process in the way you are capable of doing it, not how you think it should be done in a perfect world. After you have a draft procedure, train the involved staff and start executing the process. You don’t have to wait until the procedure is finalized or the ISO QMS is fully implemented to start executing Corrective Actions, for example. This is a great opportunity to learn and implement practices that are effective while ditching things that don’t work and while you can easily update your draft documentation.

One important note: I mentioned writing procedures. Corrective Action, Preventive Action, Non-Conforming Material, and Internal Audit are required procedures for an ISO 9001 QMS. You don’t have to write a procedure to describe every process. In fact, the most common mistake organizations make when implementing an ISO 9001 QMS is over-documenting: writing too many procedures that end up not followed, not used, not updated, and not correct. So it is important to note that I list writing procedures as an important step for these continual improvement processes because the ISO Standard requires them. (Note the emphasis on continual improvement in the ISO 9001 requirements it involves four of the six required procedures. There are also key required records associated with these processes.)

Focusing on the Continual Improvement Processes

Corrective Action is the process you use to fix the root causes of problems. They could be internal process problems (office or production), product problems, or even problems with the QMS. There are some basic steps that have to be included: fix any current problems, investigate root causes and solutions, make necessary corrections/improvements, and then verify they are effective and the problem doesn’t reoccur.

Preventive Action is the process of making improvements before a problem occurs. Frequently organizations struggle with Preventive Actions; perhaps because they envision preventive action as being something big or major. That doesn’t have to be the case. Small improvements prevent problems as well. So the real goal for the preventive action process is to create a system that documents all improvements – big and small.

Nonconforming Product is where you log defects found either in receiving inspection, manufacturing, or customer returns. Each defect needs to be logged, isolated from good product, and a disposition determined, which could lead to a corrective action.

Internal Audits are used like instruments to measure the effectiveness of the ISO 9001 QMS. Of course, your internal audit team will need training and to understand the ISO 9001 QMS Requirements, so an Internal Auditor Class may be helpful.

With an internal audit procedure and audit training you can start auditing the ISO 9001 QMS even though the system isn’t fully implemented. But it provides ISO 9001 auditing practice and generates required audit records. The audit findings are also entered into the corrective action process so we can practice doing corrective actions.

Since the ISO 9001 QMS is still being implemented, some records and documents may not be available for audits. Auditors can start, however, by auditing processes put in place implementing Clauses 4.1 and 4.2 in phase one. We can use the internal audit program to continually improve our growing ISO 9001 QMS.

Additional ISO System Components of Continual Improvement

Other pieces of continual improvement include customer satisfaction and analysis of data. While there are no required procedures or records associated with them, you still need to have defined processes for capturing data about customer satisfaction, and for regularly collecting and analyzing data from the critical processes identified in the Quality Manual. After all, improvement is the whole point of implementing the ISO 9001 QMS, and one key to improvement is to set objectives for your processes and then regularly compare actual results to the objectives, and then taking action to correct deficiencies.

Now you have completed phase two of implementation by putting in place your continual improvement processes. Next week we will cover phase three: implementing Clause 5-Management Responsibility and Clause 6- Resource Management.

St. Louis, MO – February 27, 2009 – Bizmanualz, Inc., a business publications, training and consulting company based in St. Louis, MO, today announced the launch of a completely redesigned version of its ISO 9001 QMS Internal Auditor Training course.  This ISO training course demonstrates requisite auditing skills to beginning auditors, and is also valuable to experienced auditors and quality managers looking for a refresher course or the opportunity to discuss innovative approaches.

The redesigned two-day ISO auditor class focuses on helping participants understand the criteria, the skills, and the activities required to be an effective internal auditor as part of an ISO 9001 Quality Management System.  The class is offered regularly at the Bizmanualz Learning Center in St. Louis. It can also be conducted privately on-site for organizations that would like to hold group internal auditor or quality auditor training sessions in-house.

“We had been using the previous design for several years now, and we have continually improved and updated it,” said Don Reed, Technical Writing Director at Bizmanualz and the primary designer/instructor for the class. “We have learned so much, however, through our experience teaching the course and through carefully listening to student feedback, that we felt it was time to start from scratch and use everything we have learned to completely rework the course.” 

The ISO 9001 Internal Auditing course is currently the most popular training class offered by Bizmanualz.  The totally redesigned Internal Auditor class was conducted for the first time on February 9 & 10 at the Bizmanualz to a great success. The participants responded very positively to the new approach and the reworked materials.

“The newly redesigned ISO 9001 Internal Audit Class focuses on giving the participants exactly what they want and need from an ISO 9001 Internal Auditor class: an interactive, seminar-style discussion along with real world examples and exercises,”  said Chris Anderson, Managing Director of Bizmanualz. “For example, we no longer use PowerPoint because we just don’t feel it creates the interactive environment that participants expect and deserve.”

Mr. Reed agrees. “Professionals prefer to learn in smaller classes with an atmosphere that encourages discussions and questions; where participants share their experiences and challenges. This produces a better learning experience for everyone.”

In this auditor training course, students will learn the basics of an ISO Quality Management System, as well as how it can drive organizational improvement.  Students will become familiar with using the ISO 9001 Standard as criteria for auditing, the importance of an audit program, along with basic auditing principles.  Most importantly, however, students will learn the step by step methods of conducting an audit, and participate in an audit of a QMS process. ISO 19011 – Guidelines for Quality and Environmental Auditing is used for fundamental guidance on auditing principles and methods. Plus, all participants receive a free copy of the ISO 9001:2008 Quality Management System Requirements.

Bizmanualz schedules the Internal Auditor Training Course at least once every  three months.  Please visit the Bizmanualz website at Bizmanualz.com to register for the class or to see a detailed course description and a upcoming training schedule

Bizmanualz also offers strategic process improvement services for growing businesses as well as a range of quality training classes. In addition, standard operating procedures manuals from Bizmanualz have helped thousands of companies develop policies and procedures to standardize their core business processes and implement best practices.

In learning about our own business processes, we have identified a five level process maturity model to describe the phases in which an effective management system comes to life.  If you are on a path of continual improvement, you may find it useful to consider the concept of process maturity. In this series of three articles we will explain our approach regarding process maturity and how it serves as an aid in gaining continual improvement.  This week, we cover level one, the Reactive Phase.

Realizing the Need for Process Improvement:  Phase One – The Reactive Phase

Is your quality management system in a constant state of repair?  Each day brings new surprises: situations arise, errors are discovered, customers complain.  Did that supplier deliver the wrong parts again?

The Reactive Phase is, well, reactive.  There is no system for using information for improvement.  The staff deals with problems as they are realized according to priority and resources. Issues are addressed one by one by individual staff members who are doing their best to get things done.  Each customer complaint, shipping error, or other problem starts a reaction.  Every day seems different even though the same type of problem might arise again and again.

In Phase One of the process maturity model, processes are not well-defined and have little meaningful documentation or effectiveness criteria.  Tribal knowledge rules, while training programs are weak.  Employee experience is gained primarily through OJT — On the Job Training.

Using the Maturity Model to Kick Start Your Process Improvement

To move past Phase One you must start to document your processes, start to write procedures, think about more effective training, and develop process maps.  We believe one effective way of building an effective management system is by employing the requirements set forth in the ISO 9001 Quality Management System Standard.

Building an ISO 9001-based quality management system provides the framework to move out of the reactive phase because all of these steps are part of building an ISO management system.  The ISO 9001 standard spells out the requirements of a Quality Management System but leaves it to organizations to use the methods they want to use to meet those requirements.

You may recognize your organization in Phase One, the process maturity level of many organizations.  Few organizations are able to advance much farther up in management system maturity.

Next week we will look at another common phase, the Documentation Phase, and the most desired state, Phase Three, the Stability Phase.  We’ll close the month with a look at Phase Four (Corrective Action) and Phase Five (Preventive Action), the most difficult phase to reach and, therefore, the rarest of them all.

The old adage frequently applied to ISO 9001 is “Say what you do and do what you say.”  Some organizations seem to take this to mean “Write down everything you do,” but that is really not required by the standard.  The actual requirement is that processes are well-defined and responsibilities clearly communicated.  This can be accomplished through a lot of methods that require little documentation, such as training. 

The key concept is that the goal is to use the ISO 9001 Standard to improve your business, and if it becomes a burdensome paper bureaucracy, then that is probably not happening.  Using a Lean (meaning not wasteful) approach to ISO 9001 is one way to ensure it becomes a boon, not a bust, to your organization.

Lean ISO 9001 QMS – The Quality Manual

The quality manual is an important facet of an ISO 9001 Quality Management System. The goal should be to have a lean and functional Quality Manual that is easy to maintain, distribute, and most importantly – use.  This not only eliminates waste, it sets the tone that the Quality Management System and its documentation isn’t a needless burden;but an important building block to improvement.

Read more about lean ISO 9001 quality manual;

Lean ISO 9001 QMS – Quality Systems Procedures

The goal of procedures in an organization is to document key processes.  The ISO 9001 Standard does not specify any format for writing procedures, nor does it specify a length.  Since no one wants to read long-winded, boring procedures – why write them?  Why not write one, two or three page procedures using formats like flow charts and lists that are brief and easy to understand?  Again, using a Lean approach makes procedures more useful so they can benefit an organization instead of being a paper burden.

Read more about lean quality system procedures;

Lean ISO 9001 QMS – Other QMS Documents

Very few documents are actually required by the ISO 9001 standard.  But at times developing simple, straightforward documents may be the easiest way to meet the standard, but even more importantly, provide a benefit to your organization.  Your organization must reflectively and actively decide when and where documentation is needed.

Read more about lean QMS documents;

On That Note

Answer to this month’s question:

Complying with ISO 9901 does not have to be a “document nightmare.”  Understanding the requirements of the standard and developing ways to meet them does not always require a lot of documentation.  In fact, the more Lean approach you take to creating documentation, the more likely the documentation you create will help your organization.

Please feel free to contact us with any questions or comments. Also, please let us know if you’d like any specific topic addressed in our future articles.

Regards,
Chris
Bizmanualz

Determining Needed Documents

What are some of these potentially needed documents? Here is a table that lists documents you may want to consider making part of your QMS. (Referring to the ISO 9001 Standard might make some of the descriptions more clear.) Frequently particular documents may not be required by the ISO 9001 Standard, however, creating a document may be the easiest way to comply with the intent of the standard.

What a list! It doesn’t seem very “lean,” does it?

Lean Means Value – Not Small

Some of the listed documents are required, so there is no choice. The goal it to keep the required document simple, thus ensuring that it provides value. (As I attempted to convey in the two previous articles in this series.)

For the documents listed as “Strongly Implied” in the table above, there may not be an actual document requirement in ISO 9001:2000, but it may be the easiest way to meet the requirements in the standard, as opposed to verbal explanations. In addition, the items listed as “Strongly Implied” there is also value in having a document that is actually useful for the organization. An example would be the Approved Supplier List.

For the documents categorized as “Implied” or “Optional,” an organization needs to focus on the rationale for these items to see the value. For example, ISO 9001 clause 5.5.1 states, “Top Management shall ensure that responsibilities and authorities and defined and communicated within the organization.” An Organizational Chart goes a long way to effectively communicate the responsibilities and authorities. Try substituting a few paragraphs of text for an Organizational Chart and one can see the value of a simple graphic. In some organizations, this is all that is needed to meet the 5.5.1 “shall” statement.

Overall, if an organization maintained all or most of these documents in a simple value-added format, then their Registrar Compliance Audits will go much smoother. As anyone who has been through the audit process knows, anything that will help the auditor facilitate a swift completion of the audit is a big plus.

Creating Your Lean System

I hope this series will assist those who with a Quality Management System, whether it is to comply with ISO 9001, AS 9100, TS 16949, or other standards. The time savings in using a Lean approach to QMS documentation can be dramatic, as well as the value of saving paper. The greatest value, however, lies in having a document that is actually used and aids the organization by providing value, rather than a wasted document that never really used and only exists to be brought out at audit time.

For those who are just starting their journey to ISO registration to a Quality Standard, I hope that I have at least put a few holes in the “documentation nightmare” myth. As you go through your journey, first examine if the document is required. If it is, then ensure that when complete it is adding value to your organization. If the document is not required, but desired, absolutely ensure there is value and not added bureaucracy to your QMS.

A simple matrix listing required documents and non-required documents, and the value non-required documents add may help you decide which documents are needed to meet the needs of your organization and QMS.

Best of luck to all of you changing your paradigm and instituting a Lean ISO 9001 Quality Management System