For example, the ISO 9000:2005 definition states:

Corrective Action (Clause 3.6.5):
action to eliminate the cause of a detected nonconformity and its recurrence.

Preventive Action (Clause 3.6.4):
action to eliminate the cause of a potential nonconformity and its occurrence.

But does this really clear it up for anyone?

What’s the Difference between Corrective Action and Preventive Action?

Corrective action is performed on detected nonconformities.  In other words, there are real defects that exist right now and action must be taken to stop them from ever happening again in the future.  Most people get this and seem to understand the concept of real defects needing to be fixed—permanently, so they do not cause further aggravation.  But what about preventive actions?

People seem to get hung up on what a potential nonconformity is and how do you prevent it from ever occurring in the first place?  Potential defects are defects that could happen.  I think a better description would be to call these risks.  Everyone understands the concept of risk at some level.  If we keep using a dull blade on a saw, then we are taking a risk because at some point that blade is going to break.

Using a dull blade is a bad business practice, right?  So what other bad business practices are you using in your business that you should fix to prevent a bad outcome (nonconformity) from occurring?  Potential nonconformities are all around us in every business.  The question is, how do you find potential nonconformities?  The best way to find them is to look for them using common quality tools.

Top Ten Preventive Actions

1. Analyze process or product characteristics for negative trends that, if left alone, could drift into a nonconformity.  Such analysis can be documented into a control plan.
2. Install alarms to warn you when your process is drifting into a nonconformity.  Statistical process control charts provide excellent alarms.
3. Review nonconformances found in similar processes, products, or companies for ideas that could be applied to your business.  Benchmarking similar companies is great for brainstorming preventive actions.
4. Perform risk analysis to uncover latent hazards.  Failure Mode Effects Analysis (FMEA) is a great tool for process risk analysis.
5. Implement lean thinking to eliminate wastes, which are obvious signals of latent causes of future defects.
6. Establish more rigorous training programs to continuously improve your employee’s skills.  Regular training introduces new ideas into your organization that can be sources of innovation that prevent nonconformities.
7. Introduce disaster recovery, security, and contingency plans for unpredictable situations, hazards, or safety conditions.
8. Set up preventive maintenance & calibration control programs to ensure your equipment is always safe, available, and performing optimally.
9. Begin supplier surveillance audits to assist your supply chain in delivering quality product to you consistently.
10. Analyze your process capabilities to create a foundation for improvement.  Use Capability Maturity Model (CMM) or Capability Maturity Model Integration (CMMI) for inspiration.

What preventive actions do you take in your business to eliminate defects BEFORE they occur?

1. Quality Standards.  Documents and records are used all throughout the company.  Nobody should know more about quality, compliance and processes than the Quality Manager.  Your experience with Good Manufacturing Practices (GMP), ISO standards (i.e. ISO 9001), Sarbanes Oxley, or 21 CFR 820 within a regulated industry are important to managing and controlling documents and records.
2. Quality Project Management.  A Quality Manager is also a project manager managing corrective action, process improvement, and auditing projects.  One must have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention to detail helps too.  Perhaps most important of all is understanding the financial – risk-reward – trade-offs in good project management.
3. Business Process Documentation.  A Quality Manager must be able to understand, comply, and improve established company policies and procedures.  Developing standard work, policies, procedures, job aids, and business process communications are a part of the job.  A Quality Manager is also a technical writer.  Familiarity with policy and procedure writing will help you to succeed.  Technical writing conveys technical information using active voice construction, instructional design, and desktop publishing methods to transfer information into understandable and useful information.
4. Document Control.  As the Quality Manager, your Knowledge of the Quality documentation process, Document Control practices, and managing documents, records, forms, and work instructions is vital to maintaining your company’s compliance program.  A Quality Manager may be the Document Control Manager responsible for organizing documents into an easy to use and fast retrieval system.  Users need their policies and procedures to conform to requirements.  If they cannot find them, then they cannot follow them… Document control is an important priority.
5. Quality Communications.  It might go without saying but explaining business process compliance to others is what a Quality Manager has to do.  Being able to understand a variety of instructions furnished in written, oral, diagram, or schedule form helps others to follow and conform to the established best practice.  Communicating compliance and conformance is done using software such as Microsoft Word and Excel, training using PowerPoint, process mapping using Visio, Statistical Process Control (SPC) using statistics, as well as document revision control software for policies and procedures management.
6. People Management.  A Quality Manager should not be afraid of asking questions, collecting business process information, and working with others in a positive and collaborative manner.  Business processes include sensitive accounting and financial processes too.  So, you must be comfortable speaking effectively and communicating directly with all levels of personnel.
7. Quality Auditing.  A Quality Manager performs some of the quality audits.  Supply chain audits, process audits, and may even lead ISO audits an act as a Lead Auditor managing teams of auditors.  Clearly understanding the compliance requirements, collecting objective evidence, and writing up audit reports ensure the quality management system is operating effectively.
8. Problem Solving.  The Quality Manager solves problems, typically in situations where general standardization should exist, but may not be operating effectively.  Using process mapping techniques, lean, or Six Sigma process improvement methodology is essential to reducing waste and being effective in the Quality role.   A delicate balance exists between resolving problems yourself and identifying those situations that require management intervention for a solution.  Good political judgment is required where quality and compliance are concerned.
9. Team Player.  The Quality Manager is involved in teams and meetings at every level of the organization.  Management reviews, material reviews, supplier reviews, corrective action reviews, process improvement teams, audits, customer visits and strategy discussions.  A good Quality Manager is involved with many areas of the company.
10. Quality “Go To” Guy.  The Quality Manager is the person that everybody goes to to get answers about quality.  Product specifications, supplier requirements, testing, inspections, part verification, equipment calibration, corrective actions, non-conformances, workers compensation, benchmarking, voice of the customer, and on and on.  The buck stops here at Quality.

The Top Ten Quality Manager Job Description Responsibilities

1. Quality Standards.
2. Quality Project Management.
3. Business Process Documentation
4. Document Control.
5. Quality Communications.
6. People Management.
7. Quality Auditing.
8. Problem Solving.
9. Team Player.
10. Quality “Go To” Guy.

As the Quality Manager you are responsible for Quality Management System (QMS) and all of its related compliance.  You manage quality policies, procedures, processes, programs, and practices, to assure the company of continuous improvement, conformance and effectiveness.  In a smaller company you may also be the document control manager, quality auditor, and process improvement specialist.  But you are always a team player that has input on anything to do with quality.

Have you gained quality improvement expertise over the years working with many manufacturing, information technology, and service organizations?   Bizmanualz understands your ongoing challenges of building a Quality Management System, implementing Lean Thinking, or the day-to-day struggles to maintain your ISO registration.   ISO 9001 assistance is close at hand.  Bizmanualz can provide quality management support either with onsite or remote assistance.

Policies, procedures, and forms documentation.  Now you can develop a simple ISO system in as little as 12 pages that requires less overhead using Lean ISO 9001:2008 conforming policies, procedures, and forms documents.  Each document is easily editable in MS-Word to customize to your situation.

Procedure management software. Once your documents are drafted you can simplify your document version control and management tasks using online software that ensures document reviews and approvals are completed prior to release.  Deliver relevant documents to every point-of-use or to your auditors via the internet.  Improved document access control, search and retrieval ensure your users have what they need.  Using an online procedure management software means no more back-up, retention, and document control findings too.

1^st and 2^nd Party audit support.  You don’t need to have a full-time internal or supplier audit staff.  Just contract experienced auditors to oversee the internal audit process, schedules, and audit plans, as needed.  You will receive timely audit reports for your supplier audits, pre-assessment audits, internal audits or full system audits.

Quality Management Support. Obtain fast answers to your quality management system questions from experienced, certified quality managers that can lead management reviews with complete records of results, follow-up on management review action items, and oversee nonconformance, corrective and preventive action processes.  Technical advise on quality policy, quality objectives, and overall QMS performance is readily available.

Continuous Improvement Support. Trained and experienced Lean / Six Sigma facilitators are available to organize, lead and document Lean / Six Sigma improvement events (like 5S, Preventive Maintenance, Set-up reduction, line balancing, etc).  Contract for a only the ISO quality, lean, and six sigma training you need.  Having problems with SPC, calibration, FMEA, control plans, customer feedback processes?  Training programs, advise, and guidance can be yours.

Using Bizmanualz provides competent and cost effective resources that reduce common audit findings and management stress related to the quality management system.  Now you can quickly resolve common audit findings related to:

• Qualified personnel and training
• Working document and record control
• Timely internal audits and management reviews
• Viable Nonconformance, Corrective and Preventive Action system

Bizmanualz maintains competent, qualified (ASQ Certified) personnel available as Lean / Six Sigma facilitators, part-time quality managers, and part-time lead auditors.  Now you have a cost effective solution using less than a full time quality staff that are available as need demands and you pay only for what you use.

Bizmanualz quality system services offer less stress for management using a working QMS to retain your ISO Certification.  Your management just reviews and approves actions on a scheduled basis.  Now that’s easy.

The Five Areas Bizmanualz can Help with Your Quality Management System

1. Policies, Procedures, and Forms Documentation Examples
2. Document Version Control and Management Software
3. 1^st and 2^nd Party Audit Support
4. Quality System Management Support
5. Continuous Improvement Support

Call us to find out how Bizmanualz can help you with your Quality Management System today.

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.

Now, what do you think of when you hear the term “lean“? Are you thinking “no fat”, as in Jack Sprat?  Do the words “efficient”, “effective”, or “no waste” come to mind?

If we put the two terms together, we get Lean ISO 9001, which means a quality management system (QMS) with no fat…an ISO 9001 system that is efficient, effective, and reduces waste within your organization. Who wouldn’t want that?

So, tell me…why do so many organizations implement huge ISO 9001 quality management systems, with hundreds of pages of policies, procedures, and forms, seemingly limitless bureaucracies, and ?

Few organizations are satisfied with the ISO 9001 systems they’ve built for themselves, yet they typically don’t want to change them. Why? Why stick with a system that causes more pain than it removes? Why not throw the old system out if it’s that bad, and replace it with a lean ISO quality system? Think of this: a lean quality management system — one that’s a mere dozen pages or so of easy-to-follow procedures, rules, and requirements, a minimum number of uncluttered forms, and no bureaucracy, which means you spend much less time maintaining your ISO 9001 QMS in top shape.

Easily Create a Lean ISO Quality System

It might be easier than you think to create a lean ISO quality system: mix one part ISO with two parts lean and you get a great quality system. Really, ISO is pretty straightforward once you introduce lean thinking into your organization.  Add lean kaizen improvement events for your corrective and preventive actions, lean standard work to create lean procedures, lean value stream mapping to define your processes, a lean dashboard to track your quality objectives, and a lean quality policy focused on your customer.

Starting with lean makes a ISO 9001 quality system implementation simple — certainly, much easier than trying to introduce a Six Sigma (DMAIC) process into your organization. Once you get lean, you’ll get ISO 9001 as well. Both are aimed at producing the same result — more satisfied customers.

To sum it up, don’t get started on the wrong foot by trying to design and implement a quality management system without Lean. Think of “a QMS without Lean” as something like “building an airplane from scratch”. It could be done, buy why would you?  Start with lean thinking and make getting your ISO 9001 registration a piece of cake.  Lean ISO quality is the way to go.

* * * * * * *

Need help “leaning out” your ISO 9001 Quality Management System?  Contact Bizmanualz to learn how you, too, can have a Lean ISO Quality system of your very own.

Document Your “Plan”

The plan is really the easiest part. Start with goals that are measurable. Document your plan using objectives, policies, procedures, and forms. Assign individual responsibilities, and you’re done. When you’re building an ISO 9001 Quality Management System, this is not hard at all.  But it gets harder, and pretty quickly.

Using Your Plan is “Doing”

The “Do” in PDCA means using the policies, procedures, and forms to realize your objectives. This means collecting data, and populating your forms. You have to use your procedures and follow your policies. While this may sound easy at first, keeping it up is the hard part — you may start with good intentions (that’s the “plan” part), but as they say, “Good intentions don’t pay the bills.” Your company has to follow through on its intent, and follow-through — commitment — starts at the top. Furthermore, management commitment isn’t an isolated event — it’s part of the company philosophy.

In case you missed that, let me say it again: “doing” takes management commitment. That’s a large part of what makes PDCA so hard. As management, you get so involved in running the day-to-day aspects of the business that you forget that you started with good intentions (the plan).  It is not that the plan was ill-conceived; it’s that there’s more to it than a piece of paper. Plans need continual reevaluation — you need to constantly “check” your progress and adjust the plan accordingly.  What’s so hard about checking the plan?

“Check” Your Plan

In the “check” step of PDCA, you have to convert data into information. Charting data can make this much easier but even so, a chart is just a visualization of data.  A chart is not information without a target. In addition, you need enough data points to show trends. Furthermore, you need to understand how to separate the “vital few” data points from the “trivial many”.

Creating information from data requires what Deming called “profound knowledge” about your system.  Of course it helps to understand statistics, too.  Creating information out of data is not easy; often, it requires that you continually dissect the data and look at it from many different points of view.

“Act” On Your Results

So, let’s say you started with a good plan, you were able to collect some meaningful data, and you turned it into useful information. If you’ve accomplished this, the “Act” phase should be easy, right? Possibly, if you have a stable environment.

Today’s business world is an increasingly unstable environment — old and new forces are continually changing the dynamic.  There’s local and global competition, widespread and affordable technology, weather and climate, cultures, beliefs — a host of forces acting on your business. Deciding what to do to compensate for or leverage external forces has always been difficult; it’s just becoming more so. But if you do a good job at the first three phases, the “Act” phase becomes a lot easier.  You just need to make better information out of your data.

PDCA

So there you have it.  Plan, Do, Check, and Act — PDCA, for short. It’s one of the cornerstones of the quality world, of the ISO 9001 standard. If executed correctly, it can help you get control over a seemingly chaotic world.  Yes, it is hard to do PDCA right…but what’s worth doing well that isn’t difficult, too?

If it were that easy, everyone would be doing it…don’t you think?

Some of you aren’t buying the “fear, uncertainty, and doubt“ story, though. You’re going about your business logically, methodically, and with a clear sense of direction and purpose. You’re making things happen now and you’ll be in the lead when 2011 rolls around.

For the rest of us, there are many things we could be doing to make great strides forward in the coming year. Among them are implementing or refining the following key procedures:

10. Vendor Evaluation – We’ve all outsourced many of our “non-core” functions, but how many of us are guilty of inattentive behavior with respect to our outsourcers? You get a little complacent and what happens? Deadlines start to slip, or substandard product starts to sneak in. Now is a good time to evaluate your product and service vendors to see if they’re measuring up to your standards.

9. Document Control – Do you know if your employees are following the same guidelines? If you had to ask an employee to take over another’s duties for the day because of an illness, would that first employee know where to go for information? Do they have access to the latest version of the procedure? It’s important that you keep your documentation, however critical it is, under control.  One easy way to do this is using policy management or document compliance management software.

8. Process Monitoring and Measurement – Companies that don’t monitor and measure their performance have no way of knowing for certain if they’re doing better than they were six months or a year ago, or in which direction they’re headed. We can’t improve what we don’t measure.

7. Control of Nonconforming Product – One of the worst things that can happen to your company…worse than finding an error on the production line, worse than finding a nonconformity during inspection…is having a customer find a nonconformity for you. Nothing hurts your company’s reputation worse than a customer finding a poor quality product, getting a late delivery, or finding a billing error in your favor.

6. Identification and Traceability – This is one of the biggest issues in food safety. As important as identifying unsafe product and removing it from the food supply chain is tracing the offending product to its source. ISO 22000 already had a clause addressing traceability when ISO developed a new standard, ISO 22005, to address the issue further. Whether you’re in the food business or another line of work, your customers will benefit from improved traceability of your components.

5. Competence, Awareness, and Training – Very few things improve your company’s performance — and reputation — more than a well-trained, capable work force. Ongoing training not only helps your employees gain self-confidence; it lets them know how important they are to your success.

4. Customer Satisfaction – Some refer to it as “customer loyalty”; others call it “the customer experience”. Whatever label you give it, your company wants to do more than retain customers. You want your customers telling all their contacts how great you are, how if every supplier was as customer-conscious as you, their business would be exceptional.

3. Control of Records – “Those who ignore the past are condemned to repeat it.” (Santayana) Your quality records, your accounting records, your sales records — these are the foundation for your company’s success, now and in the future. Barring the invention of a foolproof “crystal ball” app for your smartphone, knowing where you are in relation to where you’ve been and acting on that knowledge to improve your processes are key to your growth. Without adequate recordkeeping, you are flying blind into the future.

2. Internal Auditing – The best way to ensure the effectiveness of your operations and the viability of your organizations is to have your systems — accounting/finance, operations, IT, quality, etc. — audited. You should have a third party, someone with knowledge, experience, and impartiality, periodically audit your systems. In between, you should self-audit your systems to ensure that they’re in compliance, are effectively implemented and maintained, and that they’re achieving the desired results.

And the most important procedure you can implement to improve your quality and performance in 2011?

1. Corrective and Preventive Action – It’s a two-way tie for number one. Corrective and preventive actions are intertwined, though they’re not interchangeable.

A corrective action is the one you take to ensure that a problem does not happen again. A preventive action is what you do to prevent, or lessen the likelihood of, the problem from happening in the first place. Think of a heart attack: surgery to repair the damaged heart, combined with other measures (improved diet, exercise, etc.), is a corrective action. Regular exercise, a healthy diet, and (when you reach a certain age) regular visits to a cardiologist before you have a heart attack are a preventive action.

And, don’t forget what binds these procedures together — a mission, vision, and strategic plan for your firm. More on that later. For now, what do you think? Are there any procedures you’d add to, or take out of, this list? Would you put them in a different order?

Lack of Management Support

Top management must be absolutely, unequivocally committed to the idea that implementing a quality management system will improve the business. If management isn’t sold on the premise, the rank-and-file isn’t going to buy it. ISO 9001 puts it this way:

Top management shall provide evidence of its commitment to:

• Developing and implementing the quality management system; and
• Continually improving the effectiveness of the QMS.

What do you suppose the developers of ISO 9001 meant by “providing evidence of commitment”? A quick e-mail to a select group of individuals, saying “good old Wutsizzname” has been assigned the task? Or, does it go much further than that?

Insufficient Resources

Management has to ensure the availability of resources needed to develop, implement, and maintain the company’s QMS. By resources, ISO 9001 means people, training, equipment, tools, funds, and time. To ensure that there are adequate resources for your QMS, you need SMART objectives and you need a development, implementation, and maintenance plan.

These aren’t separate plans, either. They’re all part of a larger plan. The development, implementation, and maintenance phases of your QMS each have to be planned with the others in mind. Are you familiar with the saying, “The whole is more than the sum of its parts”? Well, nowhere is it truer than your QMS.

So, set your objectives, make your plans, and provide appropriate and sufficient resources. Monitor the progress of the project and adjust as needed.

Or, take a wild guess as to how much and how long it’ll take to develop your QMS. (You might get lucky.)

Poor Communication

For your QMS to conform to ISO 9001, top management has to communicate to the entire organization how important it is to meet customer and regulatory requirements. You didn’t need ISO 9001 to tell you that, did you?

The quality standard also says that “top management shall ensure that responsibilities and authorities are defined and communicated within the organization.” If Wutsizzname is the lead developer of the QMS, he has to be a developer in more than name only. Top management has to be clear about what his responsibilities are and how far his authority extends and should make it clear Wutsizzname is backed by management.

Poor communication isn’t simply a matter of what you say — it’s mostly what you do (or don’t do).

Lack of Customer Involvement

Customers and their satisfaction are the heart and soul of every successful business. And it’s not just external customers that deserve the company’s attention — there are internal customers for every project and process, as well. The ISO process model doesn’t make a distinction — a customer is a customer.

Customers of the QMS include procedure users. Their satisfaction may be measured by how well a procedure is executed, time after time. The best way to ensure customer satisfaction (i.e., consistently outstanding execution) is to involve the users in developing the procedure.

Who would know better than they whether the procedure accurately depicts the process in question? Why wouldn’t you have the users — the process owners and stakeholders — test and validate the procedure before its implementation?

In other words, if you tell Mr. Wutsizzname, “Don’t bother the people in XYZ department with silly questions – just write the procedure“, is the result of that procedure likely to come anywhere near what you expect?

Recapping the seven ways you can make your QMS project a success:

• Have a positive attitude;
• Carefully craft a comprehensive development plan;
• Manage your expectations;
• Ensure the unqualified support of top management;
• Provide sufficient resources to get the project done right;
• Keep the lines of communication open at all times; and
• Involve users/customers in the development process.

Is there anything that I missed? Anything you’d like to add to the list? If your QMS project — or any other major project of yours – didn’t turn out like it was supposed to, what would your experiences tell you to do differently?

I appreciate all your comments. Thanks for your time, and best of luck.

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.

Static versus Dynamic Systems

When I was studying engineering in college we had to take many different classes in control.  The simplest ones to talk about are the mechanical versions of static systems and dynamic systems.  Static systems are those that don’t change over time like a bridge or a flag pole.  You had to figure the forces on these systems and calculate the stress, tension, torque, etc.  I found statics pretty straightforward.

Next came dynamic systems, which are static systems that can (as a result of other forces) change over time like a suspension bridge that sways in the wind.  Things got tricky, fast.  We had to use fancy calculus like differential equations to solve the problem.  Why (you might ask)?

The thing about static systems is that you have no feedback.  So the static equation is drawn with the forces in balance and feedback set to zero.  With no feedback the problem is easy or relatively easy using basic calculus.  In contrast, dynamic systems have feedback.  The wind pushes on the bridge and the bridge pushes back (basic physics: a force is met with an equal but opposite force).  This “pushing back” starts the feedback, but feedback can also produce feedback loops, which means the bridge begins to oscillate as it rocks back and forth in the wind.

You see the wind is not a constant force, its velocity changes over time.  So this is a complex situation that becomes difficult to solve.  If we fail to produce the right answer, the bridge could fall apart in the wind (it has happened).  Positive feedback loops amplify the signal and can cause such destruction (i.e. a vicious cycle) whereas negative feedback loops reduce the signal and result in… control.

So when you design your procedures, are you designing in positive feedback loops that amplify your output and lead to the destruction of your process or are you designing in negative feedback loops that result in the control you are looking for?

Static versus Dynamic Control

Funny, we have to take into account the dynamic nature of a bridge before we built it but do you take into account the dynamics of a business process when you capture it in your knowledge management system?

Business policies and procedures are not static.  They involve people that provide feedback; they involve customers, suppliers, and management that all provide feedback. So how do you integrate this natural feedback into your procedure?  Start by planning for it.  Plan for both positive and negative feedback but most importantly harvest the negative feedback.

Planning for feedback means data, scoreboards, process reviews, process audits, management reviews, customer and supplier surveys, discussions, interviews, comments, and most of all collaboration.  We need to design collaboration into business procedures to allow for the natural feedback process to occur.  Just like building a bridge requires us to understand the forces at work BEFORE we build the bridge, so it is with building business policies and procedures.

Compliance and Control

Can you really have compliance without control?  You can check the box that a business procedures exists but a procedure requirement is not about existence it is about deployment and usage.  There is a reason for every requirement.  The standards we talk about (ISO 9000, Sarbanes Oxley, GMPs) are all about reducing risks or reducing risks using negative feedback right?  The next time you have to write business procedures think about how you can introduce negative feedback to obtain the control that the standards are really asking for.