The Quality Specialist™

ISO 9001 - Frequently Asked Questions (FAQs)

2010-04-30T07:38:00.001-06:00

This month, I'm publishing a few more questions that we're asked on a regular basis. We hear these questions so much, that I've included them in my ever-growing my list of "Frequently Asked Questions":

Q: Is ISO 9001:2008 the right Quality Management System for my business?

A: The answer to this question may, in part, be found in the requirements of your customer(s), if such requirements have been established by contract or order. Depending on your industry, suppliers are often required to maintain a Quality Management System (QMS) compliant with ISO 9001:2008, aerospace suppliers to AS9100 rev. B, nuclear suppliers to 10 CFR 50 Appendix B, oil and gas to ISO/TS 29001:2004 (API Q1) and the list goes on and on from there...

Q: I've seen ads on the Internet for pre-written Quality Manuals and other program documentation. Is this a good approach?

A: For your system to be truly effective, it should reflect your business accurately. Instead of revising your existing processes to meet a program that you purchased on-line, my personal belief is that it's always better to develop the required documentation to reflect what you're already doing. Some adjustments to existing processes may be necessary to comply with the requirements of the applicable standard, but this way, you won't need to "start-over". While the initial time and cost of this approach may be somewhat higher, you'll save over having a program that isn't used, that you aren't happy with, or that needs to be re-written in the near future.

Q: My company isn't very large; do we need to hire a full-time Quality Manager?

A: ISO 9001:2008 requires the appointment of a Management Representative by executive management; it doesn't mention anywhere the need for a full-time Quality Manager. There's no reason that the responsibilities for your program can't be delegated between functions within your organization.

Q: If we're writing documentation to ISO 9001, how many procedures will we need to develop?

A: This is a question that will be specific to your organization. While ISO 9001 requires that an organization develops a Quality Manual and a minimum of six procedures, the exact number of procedures required should be based on the organization and the scope of the activities it performs. While procedures for document control, records, internal audits, control of nonconformances, corrective action and preventative action all are required by the ISO 9001 standard, this is only a minimum requirement. The organization should consider the other activities it performs, and determine what, if any, additional controls are needed. Such additional controls could include, but should not be limited to, procedures for training, control of measurement and test equipment, purchasing, contract review and other areas.

Q: We're looking to get ISO 9001:2008 certified; how long will this take?

A: This is one of the questions we're asked most frequently, and will really depend on the level of commitment and involvement by the client, not to mention the size and complexity of their operations. As with any other major project, the organization's executive management should establish a working group or team to lead this project, a project plan and budget, and make sure that adequate resources are available to ensure the success of this effort.

Q: We need consulting assistance to get ISO 9001 certified, but we also need to control costs. What options are available?

A: Consulting assistance can vary, ranging from the consultant acting in an advisory capacity, to providing consultative help, to collaboration. The degree of involvement will be a primary factor in determining what this consulting assistance will cost. Needless to say, the more time on-site and the more "hands-on" involvement a consultant has, the higher this cost will be. Bear in mind also, that if a consultant is left to do everything, you really haven't taken ownership of your program. The best programs are those that are "owned" by the organization, and reflect the organizations unique business needs and conditions, not simply the consultant's idea of what a good program is.

Q: If we achieve ISO certification, we will then be audited by our Registrar on a regular basis. Will this meet the requirements of ISO 9001:2008 for periodic internal audits?

A: No. The audits performed by your Registrar will be for the purposes of either initial certification, surveillance (including follow-up audits) or recertification. Registrar audits are a third-party assessment focusing on the certification status of your program. Internal audits, in contrast, are an internal assessment performed by management, for the purpose of verifying conformance with applicable requirements and for identifying improvement opportunities. While these two activities may seem vary similar at times, an internal audit is still required.

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ISO 9001 Quality Consulting

2010-04-30T07:33:00.001-06:00

ISO 9001 Quality Consulting

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ISO 9001 - Design and Development - Design Input

2010-02-08T08:51:00.001-06:00

Many organizations struggle with understanding design inputs as specified by the ISO 9001:2008 standard in clause 7.3.2. As part of these requirements, the organization is required to ensure that “inputs related to product requirements are identified and records maintained”.

In order to clarify what design inputs are, we must understand that design and development is a process, which therefore requires us to first define what a process is. While there are a variety of different definitions related to this subject, one of the most illustrative definitions of a process is provided by Hammer & Champy (1993)[1]:

”a collection of activities that takes one or more kinds of input and creates an output that is of value to the customer.”

Personally, I like this definition of a process, as it’s simple, relatively straightforward and it usually minimizes the amount of further explanation required. While this definition is applicable to the ISO 9001:2008 standard in its entirety, when applied specifically to design and development, we can state that our design and development process (clause 7.3) is the manner in which we transform design inputs (clause 7.3.2) into design outputs (clause 7.3.3).

In clause 7.3.2, the ISO 9001:2008 standard identifies several types of design inputs that shall be determined by the organization, including:

• Functional and performance requirements

• Applicable statutory and regulatory requirements

• Information derived from previous designs

• Other requirements essential for design and development

In some cases, particularly where design and development activities are performed on a made-to-order basis, the initial design inputs are established as part of an order provided by an external customer, specifying their needs and expectations. This order is reviewed as part of clause 7.2.2 of the ISO 9001:2008 standard (see Customer-related processes), and upon acceptance by the organization, the information provided becomes a primary, albeit not exclusive, source of design inputs for use by the organization.

Alternatively, design and development activities may be performed to create new products or to update existing products. In such cases, these activities are not initiated by an external order, but rather by a management directive or similar order of an internal nature, in order to meet an identified market, commercial or strategic needs identified by the organization. Similar to an order received from an external customer, such internal information also serves as a primary source of design inputs.

It is important to note here, that the list of design inputs specified in 7.3.2 is not all-inclusive; in fact, the fourth type of input identified by the standard is simply indentified as “other requirements essential for design and development”. This is really a broad requirement for the organization to identify all other internal (organizational) and external (customer) inputs to ensure that all applicable needs, expectations and requirements are addressed. This could include, but would not be limited to, requirements specified by applicable codes, standards and specifications, supplier-provided information, competitive analysis, feedback from previous products, process performance data, etc., etc., etc.

Not only is the organization required to identify these inputs, it is also required to keep records relating to these inputs and to ensure that these inputs are formulated in a way that can be verified and validated. Inputs must also be reviewed by the organization prior to use, to ensure that the inputs are adequate and that there is sufficient information to carry out the assignment. Consideration must also be given to ensure that inputs are complete, unambiguous and not in conflict with each other.

*[1] Michael Hammer and James Champy (1993). Reengineering the Corporation: A Manifesto for Business Revolution, Harper Business

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ISO 9001 - Your Management Representative

2009-07-10T07:47:00.000-06:00

As part of ISO 9001:2008, clause 5.5.2, the standard requires that Top Management appoint a member of management to serve as the Management Representative for the organization’s Quality Management System.

Expanding upon this requirement, we can consider this appointment to include the responsibility and authority to manage, monitor, evaluate and coordinate the organization’s quality management system as necessary to meet customer and other requirements and to achieve specified quality objectives. This individual would also then be responsible for communicating with Top Management, as well as the customer and other interested parties on matters pertaining to the organization’s quality management system (see ISO 9004:2000 also).

This appointment is typically documented by Top Management (e.g., President, CEO, COO, etc.) in the form of an appointment letter or other similar written statement; however direct reference within the organization’s quality manual is an equally acceptable method. In the later case, the responsibility and authority is not delegated to a particular individual, but rather to a particular position/title within the organization’s management structure, which is then assumed by an individual when they are assigned to this particular role.

Specifically, as stated within the ISO 9001 standard, the responsibilities of a Management Representative are as follows:

Ensure that the processes needed for the organization’s QMS are established, implemented, and maintained;
Report to top management on the performance of the QMS to Top Management and any need for improvement;
Ensure the promotion of awareness of customer requirements throughout the organization; and
Act as liaison with external bodies and customers on matters relating to the organization’s quality system.

While these responsibilities are defined within the standard, they are by no means all-inclusive. The actual scope of the Management Representative’s responsibility will undoubtedly vary from organization to organization, as each organization will have its own unique needs as determined by its size, the scope and the complexity of its operations, and other factors.

It’s important to note here, with regards to the responsibilities stated above, the use of the terms “ensure” and “report”, and the absence of any reference to the actual (hands-on) development, implementation and on-going maintenance of the management system itself. For these activities, it is the responsibility of the organization to define the individual who is responsible; in some organizations, it may be the Management Representative, or it may be assigned to other personnel within the organization.

While ISO 9001 does require that the Management Representative to be a member of management, no guidance is provided on the actual selection process, particularly with regards to the skills, knowledge and or abilities that are desirable. Again, this is left to Top Management of the organization, as they must ensure that the individual selected has the traits necessary to ensure that the outcomes desired by the organization are met.

The process of selecting a Management Representative should consider the responsibilities that this individual will assume and the role they will play in the actual management of the organization and its activities. For large organizations, this will require a degree of management "savvy", the ability to interact with key decision-makers as well as make key decisions, the ability to ensure conformance and to drive change. For smaller organizations, the management representative may be required to take a more hands-on approach, handling not only management issues related to the QMS, but also being directly involved in the administrative functions that make up this system and keep in it running.

An understanding of the requirements specified by the ISO 9001 standard is obviously necessary; however a deep level of subject matter expertise may only be necessary if the individual is going to actively manage the day-to-day activities and functions associated with the organization’s management system. Regardless of the capacity in which the Management Representative will function, competency is the keyword.

As a final note, you may have realized that I never mentioned the position of Quality Manager (or similar title) in this article. There’s no reference or requirement in the ISO 9001 standard regarding this position. A Management Representative is a required by the ISO 9001 standard; having an individual assigned as Quality Manager is not – it is a choice made by the organization, based on resource needs and other factors, including the products and services offered and the degree of control that is required. For small organizations, there’s often little value obtained by adding additional head-count, as the duties required to maintain and administer a system can be shared amongst existing personnel. For larger organizations however, the level of activity is much greater, and often necessitate this position, or similar, to ensure compliance with specified requirements.

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Breakthrough Performance

2009-05-01T06:32:00.001-06:00

I’m going to start this article by noting that I’ve never been a huge fan of the practice of benchmarking, particularly within one’s own industry. As a personal belief, I think that this practice establishes false performance standards that ultimately limit the performance of an organization, rather than to promote its on-going development. While some companies may initially benefit from this exercise, benchmarking places emphasis and value on another’s accomplishments rather than on promoting an internal culture where truly breakthrough performance is a regular occurrence.

In order to realize breakthrough performance, we need to re-calibrate the way we rate our performance and move away from a relative scale (ourselves vs. our competition) to an absolute scale (perfection). Average businesses are those that meet customer expectations, while better-than-average businesses make every effort possible to exceed these expectations. In contrast, businesses that are truly noteworthy have learned to shatter these expectations by performing at a level that the customer had yet to even consider. This level of performance doesn’t come from benchmarking; it doesn’t even acknowledge that the competition exists.

The competition is irrelevant. If you’re referencing your performance against that of a competitor, you may be performing better or worse or even equal to, however this also means that you’re still comparable. Assuming that you and the rest of your competition are doing things the same way, using the same performance standard, you’re not a true industry leader - you’re still just a follower, albeit you may be on the upper-to-high side of mediocrity. To coin a phrase, think “a league of their own” – not only should you be better than the competition, you shouldn’t even playing in the same ball-park. There’s a reason Hyundai’s and Ferrari’s don’t race together.

Perfection should be the goal. Industry best-practices should only serve to identify the minimum level of performance that should be tolerated; these practices shouldn’t ever be considered as a basis for goal-setting. To survive in a competitive business environment, we shouldn’t be focusing on best practices, but rather, we should be constantly looking to develop even better practices. To have the “least” amount of rework, repair or returns, or to have the “most” on-time deliveries is the point from where your continuous improvement journey truly begins, rather than being the end. The real goal is an absolute one - to never have any bad product, never have any returns and to always deliver on time. While I acknowledge that such a level of performance is nearly impossible to attain and its achievement is subject to an endless list of constraints, perfection should always be the target that we’re aiming for.

The past is history. I can't discount the importance of "lessons learned" or the value of celebrating past accomplishments, however I will say that the only time that really matters is now and tomorrow. Success doesn't consider where we started, where we’ve been or how far along we’ve come; there isn’t any award given to the organization that’s the "most improved". The most important measure of performance is not the one that's behind us, or in the case of our competition, around us - it's always the one that's in front of us. Going forward, the goal is more than merely replicating the incremental gains of the past - its about finding new ways to exponentially improve our performance.

Breakthrough performance has nothing to do with your competition. It is about where you are now, and where you are going; it is about your future state and how far (or how close) you are to a state of perfection. Just because you are as good as your competition doesn't mean that your competition is any good.

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ISO 9001 - The Adequacy of Your QMS

2009-03-04T08:41:00.001-06:00

While I’ve briefly touched on the topic of QMS adequacy in previous discussions, I decided to commit an entire article to this subject based on its considerable importance. Many organizations experience difficulty with the concept of adequacy as it applies to their QMS; they really don’t have a full understanding of what this term relates to, or more importantly, how to assess whether or not their QMS is meeting this key requirement of the ISO 9001 standard.

Before we go any further, let’s first consider the meaning of the word “adequate”, or as used in throughout this article, “adequacy”:

Adequacy – Sufficient to satisfy a requirement or meet a need*.
*Random House Unabridged Dictionary, © Random House, Inc. 2006.

From the definition above, we learn that “adequate” relates to meeting both requirements as well as needs. If we apply this definition within the framework of an ISO 9001 based Quality Management System, we can therefore determine that a quality management system should be capable of satisfying applicable requirements including those specified by the organization, the customer, and any applicable standards and/or regulations.

In developing your QMS, and in the subsequent evaluation of its on-going performance, an adequate QMS means much more than simply addressing the clauses that make up the ISO 9001 standard. In addition to the requirements of ISO 9001, what are the governing codes, standards and/or specifications that the organization is working to? What customer specifications and other requirements does the organization need to meet? Finally, what other policies and other procedures have been established by the organization, and how does this QMS serve to ensure compliance? All of these considerations must to be taken into account when determining whether or not a Quality management System is adequate.

Assessing a QMS for adequacy however, relative to the above considerations, can be problematic for many organizations. With insulated management and silo-like structures, these organizations lack a comprehensive understanding of what requirements they’re actually working to. Such requirements may be known to pockets within the organization, but often they are not known across the organization, so there is little or no global understanding or awareness.

While a single organization, which produces a single product, in accordance with a single set of requirements is most likely a simple case requiring a simple solution, the complexity of many organization's operations makes their identification of these requirements and needs considerably more difficult. Multiple sites, multiple products, multiple standards, multiple sets of customer specifications, etc. all factor into the adequacy of the QMS. Without a good understanding of your entire business, and the corresponding requirements and needs that apply, it is nearly impossible to make a valid assessment of the adequacy of the QMS.

Just because an organization that has a documented system that addresses the requirements of this ISO 9001 standard, this only contributes to its adequacy; it doesn’t totally satisfy this requirement. In order to be totally compliant with ISO 9001, you QMS must not only address each applicable requirement of the standard, but also be in compliance with any additional requirements that may apply to your organization and its products. This means that a typical ISO system audit, in-and-of itself, has limitations as far as this determination is concerned. Product and process data can be used to supplement any conclusion, but as these are typically reactive measures (based on identified nonconformances), they only address issues when noted, rather than evaluating all areas of concern.

So exactly how do you find out what all of these requirements are? - Better start asking, researching and learning. If this is a new QMS or one that's under development, it's always better to find out at the beginning

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Fourteen Points of Total Quality Education

2009-03-04T08:30:00.003-06:00

Libyan Labiosa and Philip Cassone from the International Center for Accelerative Learning (ICAL) provided us with the following guest feature, which is an adaptation of Deming's "14 Points for Management" to corporate training and educational processes; the result - Total Quality Education.- M. Randig

Dr. W. Edwards Deming’s principles support the global success of Toyota, Proctor & Gamble, Ritz Carlton, Harley-Davidson, and many other leading organizations. His teachings are essential for the effective application of Six Sigma, Lean Manufacturing, Loyalty / Net Promoter and other quality improvement, customer retention and business growth methods.

Deming’s 14 Total Quality Education points were created for the White House Task Force for Education in 2000 and presented to a congressional committee by Libyan Labiosa in conjunction with her position on the board of the National Learning Foundation within the United States Department of Education.

The 14 TQE points are as meaningful today as they were a decade ago. For education to be meaningful in a rapidly changing world, it must adapt. We are in a globalized society and the worldwide education system must adapt to fit the times ahead. To date the results have not been encouraging.

There is an international test from the Organization of Economic Cooperation and Development (OECD) that measures average mathematics literacy, reading literacy, science literacy, and problem-solving scores of 15-year-olds from over 50 industrialized countries. The highest possible score is 1000.

Currently the highest scoring nation in the world is Finland with a average score of 550 and the USA is in 29th place with an average score of 483.

In the USA, Massachusetts is the highest scoring of all 50 states with only 44% of its students at performing grade level in 4th and 8th grade. Washington DC is dead last with less than 10% of its students performing at grade level.

It is clear that Deming’s 14 points of Total Quality Education bear taking another look at in a time where the best scoring nation in the world is only at 55% and the best scoring state in the USA is at 44%. As Deming so eloquently puts it in his quote at the end of this article, we have no less than our survival at getting our educational systems right.

Fourteen Points of Total Quality Education
(Adapted from Deming’s Total Quality Management principles)

Create constancy of purpose toward improvement of education and learning with the aim to prepare learners to be productive in a changing world.
Adopt a new philosophy. We are in a new information age. Western educators must awaken to the challenge, must learn new responsibilities, and take on leadership for change.
Cease dependence on testing to achieve quality. Eliminate the need for testing as the only way of measuring quality. Ensure that quality is always present in the classroom.
End the practice of awarding students on the basis of grades. Instead minimize competition with others. Move toward a goal of learning as a long-term reward in itself.
Improve constantly and forever the system of education and learning to improve quality and student productivity.
Institute interactive and creative teaching and learning.
Institute leadership. The aim of leadership should be to help people do a better job. Leadership of educators is in need of overhaul, as well as leadership of students.
Drive out fear so that everyone may work effectively for themselves and their community.
Break down barriers between administrators, teachers, parents and students. People in education must work as a team to foresee problems in the educational process.
Always expect the best from students.
Eliminate minimum requirements for achievement. Each student assumes a proactive role in his/her education.
Remove barriers that rob the students of their right to pride in achievement. The responsibility of educators must be changed from sheer information giving to ensuring knowledge through use of global teaching strategies.
Institute a vigorous program of education and self-improvement.
Put everyone in the system to work to accomplish the transformation.

“No one has to change. Survival is optional.” Dr. W. Edwards Deming

© 2008 International Center for Accelerative Learning. All Rights Reserved.
http://www.center4al.com/

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Customer Feedback

2009-01-26T08:14:00.003-06:00

If a customer has an issue with your products or services, some customers will complain; some will say nothing; other customers will simply take their business elsewhere, and unfortunately, you will probably be the last to hear about it. Your customer’s perception of your performance varies considerably from your own, and in most cases, you’re not doing as well as you think.

Repeat orders don’t indicate satisfied customers. What they do indicate, is that your customer hasn’t found an alternative supplier that does a better job. While some customers are extremely loyal, many are just waiting for a better option to come along. You won’t have high customer retention rate if you don’t do a good, make that great, job.

We can often relate “good” to degree that we were able to meet customer requirements and needs. The term “great” however, is much more ambiguous; it relates more to customer wants and expectations, and our ability to surpass them. If we do what we’ve agree to, on the date it’s agreed, for the price agreed, we can assume we’ve done a good job. Our internal perception of our performance is of little value; the only opinion that matters is the customer’s.

Only by continuously meeting the requirements of our customers, and relentlessly working to exceed their wants and expectations, can we ensure genuinely satisfied customers (and long-term customer retention). Customer requirements continuously evolve and their wants and expectations are dynamic. Perception is just as important as actual performance, and there’s no way to gauge a customer’s overall experience without asking – How well did we perform? What can we do better?

Below is an overview of a basic customer feedback process, which breaks down each activity into one of four primary steps: Development, Distribution, Recovery, and Analysis/Reporting. There is no one-size-fits-all solution or approach, but this should be enough to get you started.

Development

There are a variety of methods for acquiring customer feedback; each method has its own particular strengths and weaknesses, and requires varying degrees of resources. Methods for obtaining feedback may include surveys or questionnaires, user groups or smaller focus groups, one-to-one interviews and more. For the sake of brevity, I’ll stay away from any discussion on survey design here, but such methods for monitoring and measurement should be controlled appropriately; the development process should ensure that the method is reliable, repeatable, and that the information it obtains must not only be quantifiable, but must also be relevant to the organization, and to the achievement of its stated goals and objectives.

Distribution

In order to obtain useable, relevant information, we need to ensure that we reach the right personnel within the customer’s organization. In larger organizations, this can be a daunting task; with silo-like structures common to both organizations, it is not unusual to end up approaching the wrong individual or department. While obtaining information from the purchasing department, accounts payable, or another party that wasn’t directly involved in the work performed may help your feedback rating (most will say “great job- excellent!”), it will accomplish little more than a virtual “pat-on-the-back” – this information is useless. The only source of information that matters is from the actual user of your products or services. Your sales, production or service personnel usually know who to contact and can often provide valuable assistance in collecting this feedback.

Recovery

While finding and contacting the right people can be a challenge, it is a minor setback when compared to soliciting a response to our feedback request. The primary obstacle is that we really don’t have any sort of “carrot” – there’s no reward to offer our customers for its timely (if ever) return. Feedback tends to come quickly if there’s a problem – the customer wants the prompt resolution of their issues. If there’s no issue (except possibly marginal performance), feedback becomes much harder to solicit, as there’s little to no motivation to respond. Some retail chains have found that by offering coupons or other incentives for completed questionnaires it is easier to obtain this information. Other companies may hold a drawing or offer prizes, as appropriate; some companies may make a charitable donation each time feedback is given. Again, there are no one-size-fits all solutions, and trial and error may be needed to determine the one that works best for your situation.

Analysis and Reporting

The final step of this feedback process is the analysis and subsequent reporting of the information that has been obtained. How this analysis is performed is going to really be based upon the feedback methods used, the type of information that’s acquired, and the degree of reporting that is required by the organization’s management. Quite often, advanced statistical techniques are unnecessary, and tend to serve the ego of the analyst more than the needs of management.

Reporting may trigger other processes, such as those used for corrective or preventative action, and this data may subsequently be used as input as part of the organization’s process for management review. As I mentioned above, the information that is obtained through this process must be relevant to the organization, and to the achievement of its stated goals and objectives. Not only must this data be informative, it has to be actionable.

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The Right Time

2008-11-17T13:52:00.000-06:00

Every day there’s a new challenge, a new problem, another issue. We spend so much time trying to “hold the line”, that we forget to look after the improvement needs of our business. To remain competitive in today’s rapidly evolving marketplace, it’s essential that a business not only performs well at the outset, but also continues to develop its products, processes and infrastructure on an ongoing basis. In this scenario, improvement isn’t an option; it’s the choice between long term success and ultimate failure.

As we’ve witnessed recently in so many different industries, today’s market leader can easily become tomorrow’s market loser. All clichés aside, a business that fails to progress forward isn’t merely standing still, it is moving backwards. If you don’t improve, you’re allowing your competition the opportunity to figure out a way to do things better. When this occurs, you’ve lost your distinction in the marketplace and likely, a fair amount of your customer base, assuming they haven’t been acquired already. Distinction in the marketplace is what makes market leaders, and this distinction only lasts until the competition catches up, or comes up with a better way to do things.

It’s easy to say that the timing may be better later; that the issue isn’t important enough right now. Between fighting the fires of the day and dealing with whatever the crisis of the moment may be, it can be hard to distinguish between what really is important, urgent, what is both or what is neither. Waiting for the “right time” to address improvement is about the same as trying to improve your revenues by buying lottery tickets; the probability is there, but your chances are somewhere between unlikely and non-existent. There are two times we can safely bet on however; there is a time when improvement is beneficial (now), and there will be a time when improvement is too late. Unfortunately, the latter is risky gamble for planning purposes, as it’s usually a date you won’t see coming.

We mistakenly attempt to prioritize our need for improvement relative to internal factors (budgets, resources, scheduling, reject rates, etc.), as these influences are known to us and are within our control, hence the “right time” mentality. We ignore the myriad of external factors that exist, those that we have no control over. This allows us to view improvement as an activity that can be segregated from other core business processes, and that can be addressed on the basis of convenience and opportunity, rather than necessity. By focusing solely on these internal factors, we are often driven or forced to improve by the marketplace, rather than addressing improvement on our own terms.

The “right time” for improvement isn’t something that can be planned or marked on a calendar, as the need for improvement is perpetual. While you are checking your calendar for the right time to focus on improvement, your customers are actively looking for better ways to do business and your competition is always looking to take away your customers.

Waiting for the “right time” may be waiting for an opportunity that never comes.

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The Right Approach

2008-10-27T10:24:00.001-06:00

There are volumes of work that have been published detailing the success of quality management systems based on ISO 9001, AS9100, TS 29001 and other similar standards; the same goes for the documented success of problem-solving and improvement approaches, such as Six Sigma, Lean, TQM, RCA etc. If you research any of these on-line, your results will show hundreds of success stories, illustrating how such approaches can be successfully applied in virtually any industry or profession.

When we consider the documented success of such approaches, it’s amazing that any organization which has not adopted such sophisticated measures remains in business at all. Surely they can’t be as competitive as their peers in the marketplace with such superior capability. The progressive organization has learned to execute their operations with the precision of a laser scalpel; the dinosaur relies on outdates processes with the exactitude of trying to eat peas with flimsy, plastic cooking spatula. The organization who has the lowest DPMO, the most procedures, great process maps and the most black belts must always win.

With such overwhelming success, I’m surprised that I continue to regularly encounter folks who are steadfast in their belief that these approaches are nonsense; that they don’t work. To these individuals, such approaches are nothing but “flavor-of-the-day” initiatives, a combination of buzzwords and over-hyped methods, gestures or tricks with no end result other than to line the pockets of consultants at the expense of the well-meaning organization. This later opinion is inconsistent with the documented results - surely there is something missing. With so many documented success stories, there can’t be anything wrong with these approaches, can there…?

Unfortunately, many of these later opinions are based upon valid reasoning; they are the views of individuals who have seen the failures personally; they have suffered through poorly managed projects, tutelage under the guidance of less-than-capable consultants, and have experienced the disastrous results of ill-conceived initiatives. Huge costs have been incurred by the organization, countless hours have been wasted, personnel have been reassigned and morale has been left shattered. What began as an optimistic attempt to improve the condition of the business has either made no impact, or has left the organization in a worse state than ever before.

Which side is right here? Are these approaches successful or just hype?

We need to quit trying to address with this subject in absolutes. There is no “one-size-fits-all” solution; there is no global solution that can be applied in all cases. Each business has their own unique needs, circumstances and business objectives. Such approaches can be wildly successful; they can also be absolute failures. You can’t just say the “ISO 9001 doesn’t work", “Six Sigma doesn’t work”, or “Lean doesn’t work”. It just may not work for you. The same goes for saying that any of these approaches does work, without exception.

We incorrectly attribute the success (or failure) of an approach almost exclusively to the methodology itself, without taking into consideration the context in which it was applied, or the need which it was intended to address. Each of the aforementioned approaches (ISO 9001, Lean, Six Sigma, etc.) has some degree of merit, and each has been successful in their own right. Each has its own unique strengths and weaknesses. The "right" approach however, is the one that fits best with your organization.

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ISO 9001 - Customer Property

2008-10-20T09:20:00.003-06:00

In clause 7.5.4 of the ISO 9001 standard, we find requirements for the control of customer property. As established in this clause, an organization is required to establish measures for the control of customer property, while it is under the organization’s control or being used by the organization. This clause also addresses the organization’s responsibility to identify, verify, protect and maintain customer property, as well as reporting to the customer any problems or issues that are identified.

What Is Customer Property?

Customer property is any property that is owned (or provided) by the customer. In simple terms, customer property can be considered anything that you don’t own, that has been supplied by the customer for your use. Such product may be owned directly by the supplier, or owned by another interested party.

Examples of customer property can be found in ISO 9004:2000*, which includes the following:

Ingredients or components supplied for inclusion in a product;
Product supplied for repair, maintenance or upgrading;
Packaging materials supplied directly by the customer;
Customer materials handled by service organizations such as storage;
Services supplied on behalf of a customer, such as transportation of customer product to a third party; and
Customer intellectual property, such as specifications, drawings and proprietary information.

*Excerpt from ISO 9004:2000, Quality management systems – Guidelines for performance improvements

From the guidance above, we can therefore consider customer property to include any materials, parts, components, etc. that are provided by the customer to be incorporated into the organization’s product. We can also include any property that is used by the organization, such as customer-provided equipment, tools, hardware and software.

Intellectual property may also fall under this requirement, if its return is required upon completion of a project. If it is given freely however (e.g., public information) it would not fall under this requirement.

Identifying Customer Property

The identification of customer property is a critical part of not only identifying ownership, but is also a necessary step in preventing the unauthorized use or inadvertent disposal of customer property. Identification should be in the method appropriate to the organization, the product, the processing to be performed, any usage requirements and/or customer specified instructions. Identification methods may include labels, tags, containers, physical markings or other methods as appropriate.

Verifying Customer Property

Verification of customer property should be performed to establish the condition of customer supplied property, including conformance to all specified requirements. These verification checks may include quantity, physical condition, and other characteristics, as well as the identification or measurement of chemical, physical or other properties. Typically, this verification process would be performed upon receipt, and is usually performed in a manner consistent with the organization’s established process for the verification of purchased product.

Records of such verification activities should be maintained in accordance with the organization’s record control procedures, and notification made to the customer in the event that nonconforming product is identified (see below).

Protecting Customer Property

While under the control of the organization, appropriate measures need to be established to protect customer product from loss, damage and/or degradation. Typically, such measures would follow the organization’s process for the protection of its own property; with any additional customer requirements that may apply (various international standards are also available to address this subject). As part of such measures, a schedule for periodic assessment should be established for property that is maintained for extended periods of time. The specific interval of this assessment, and evaluation method(s) used, should be based on the specific type of product and various other factors, including shelf -life of the product, storage environment, specific customer instructions, etc.

Maintaining Customer Property

In cases where maintenance may be required (e.g., equipment, tools and/or hardware), the organization should, prior to the acceptance of customer property, ensure that there is a clear agreement and definition of responsibility with regarding to both on-going maintenance and repair. Specific terms and conditions should be established between the customer and the organization to address the types (and schedule) of maintenance required, including who will be responsible for such maintenance, as well as to establish guidelines to address extraordinary events, such as repairs due to equipment failure.

As with maintenance and repair activities performed by the organization on its own equipment, records should be maintained in accordance with the organization’s record control procedures.

Reporting of Issues

The requirements established in 7.5.4 not only address the control of customer property, but also notification to the customer should any problems be identified. Any problems or issues, such as loss, damage or failure concerning customer property should be promptly reported back to the customer in accordance with the organization’s procedures for the control of nonconforming product, as modified by any specific customer instructions. As this is customer property, subsequent processing activities should be suspended, until disposition by the customer has occurred.

Records of such nonconforming product should be maintained in accordance with the organization’s record control procedures

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ISO 9001 in Education and Training

2008-09-26T06:15:00.001-06:00

While usually associated with manufacturing and service activities, ISO 9001 should be considered equally as effective as a management system for education and training programs. If we consider the desired outcome (learning), education and training is just another form of service; the product is the knowledge, skill and/or ability that is achieved by the program attendees. As with other services, the delivery of education and training incorporates the processes of design, development, verification, validation, delivery, subsequent correction and ongoing improvement. Therefore, when we try to apply the requirements of ISO 9001 to education and training activities, we find that it aligns exceptionally well with generally accepted practices.

A fundamental objective of any quality management system is to ensure that customer needs are met. In order to define these needs as they relate to education and training, we must first define the primary customer of this service - the program attendee. I’ve used the term “primary customer” in this discussion, as numerous ancillary customers may also be involved, including the parents of the attendee, the state which provides funding to the institution, and possibly even the country in which the activity is performed (as skill development contributes to the national economy). In the case of corporate training, we must also consider the needs of the individual’s employer, the industry they serve, as well as regulatory bodies or other interested parties. The list of potential customers can be as varied as the number of offerings that are available; identification of both primary and ancillary customers is a critical part of the initial needs assessment process, and is essential to the overall success of any education or training effort.

Once the above customers have been defined, their needs must be translated into terms that can be understood by the organization, and that can be further developed to serve as a measurement of an individual’s competency. Typically, these needs are reflected through the establishment of learning outcome statements, commonly referred to as learning objectives. Upon completion of specific portion of a program (or upon the completion of the program as a whole), the participant should be able to demonstrate a defined level of mastery of the course content, or be able to demonstrate the ability to perform a specific task or activity. To determine if these needs are satisfied, the participants performance throughout this entire process is monitored, and at defined intervals, the individual’s ability to meet a defined learning objective is measured against an established set of criteria (be it quizzes, examinations, demonstrations or other evaluation methods). Once the criteria established for competency is met, the objective is considered to be achieved. This process then continues until all established objectives have been met for the program, at which point a certificate or other form of recognition is awarded.

When considering what would be required to properly design, develop and document such a system to meet the requirements of ISO 9001, we find that there is very little difference between the approach needed to develop a system for this application, in comparison to approaches commonly used to develop systems which address manufacturing activities and other services. Proper design should begin with a review of the key processes used by the institution or organization, their ability to meet the customer needs established above and their overall degree of compliance with the requirements of the ISO 9001 standard.

System documentation required by the ISO 9001 standard, including a quality manual, and the six “system” procedures required by the ISO 9001 standard - the control of documents, the control of records, internal audits, the control of nonconformances, corrective action and preventative action all have a place in this system (as do the 19 types of records addressed in the ISO 9001 standard); they are just as relevant in this application as they are with their counterparts in other industries. Additional documentation, addressing the various activities performed by the organization will also be needed, as necessary to address the critical nature of the activities performed, as well as to ensure the customer needs defined above are met.

While the ISO 9001 standard does allow for an organization to take exclusion to the requirements found in Clause 7, there are relatively few instances where such exclusion would be justified. Typical education and training activities encompass Design and Development (instructional design), Purchasing (materials and services) Validation of Processes (pilot programs and peer reviews), Customer property (information) and even the Control of Measurement and Monitoring Devices (quizzes and examinations). While the specific processes used may vary between different organizations and offerings, almost every clause of ISO 9001 could conceivably apply.

http://www.masquality.com

A Lot of Improvement - A Bit of Sense

2008-09-17T01:34:00.000-06:00

It seems that every business owner I’ve met lately is at least willing to acknowledge that, to remain competitive in today’s marketplace, they must look for ways to continuously improve their programs, processes, products and/or services. As we begin to establish a dialogue on this subject however, the discussion rapidly turns to sales, profit margins and market share; little more is said on how such improvements would occur, or in the longer term, on how such a system of on-going improvements would be sustainable.

Saying that, “we’ll do better”, “we’ll pay more attention”, or “we won’t do that again” are all noble intentions. If repeated enough times from the “C-Level” (executive management), we can create a level of awareness in our organization that hadn’t existed previously. We can continue promoting this cause further using banners, plaques, newsletters and other fan-fare (free food always draws a crowd), and watch as the awareness of this issue within our organization skyrockets, at least momentarily. We’ll make it a bullet-point for discussion as part of every meeting we have. If we print our intent on the back of enough business cards, we might even get our customers to believe it.

When we use such terms as “better”, “less”, and “more” however, it only serves to illustrate the fact that we really don’t have a measurement or indicator of how we’re actually performing in this area. Our initiatives subsequently fail, not because of our level of commitment or our promotion, but because do not know where we’re going; worse yet, we don’t even know where we’re starting from. At this point, it’s not about our sincerity or resolve, but rather the ability to define an ideal future state, and then figuring out how to get there.

Organizations don’t budget based around simply wanting to make “lots” of money or incurring a “small” expense or perform strategic planning around gaining a “bit” of market share. These activities focus on objectives, goals and targets that are important to the shareholders of the company. At our finger-tips, we are then able to pull up information that shows us our progress towards meeting these desired outcomes. We can see if our business is operating at a profit or loss and what our margins are. On an on-going basis, we monitor and report our sales performance in terms of sales volume, our ability to reach quotas, our customer relations, expense account usage, time management and other measures.

Successful organizations thrive financially not solely because of commitment and promotion, but because they plan, they budget, they develop infrastructure, they assign responsibilities, they monitor and they adjust and/or correct on a continuous basis. Relatively few organizations however, can make a similar claim, as it relates to the management of their improvement initiatives.

Commitment and promotion are all fine in their own right, and are essential pieces to completing the improvement puzzle; however, none of these gestures do anything however to actually address the organization’s present condition. While awareness can be an important catalyst for change, it’s not enough for an organization to simply want to improve.

Why again then, are we managing our improvement efforts differently than the other areas of our business…?

http://www.masquality.com

The Value of Complaints

2008-09-10T08:30:00.001-06:00

While no organization wants to hear, particularly from its customers, that its products or services aren’t up-to-par, remember this going forward - a complaint isn’t simply a negative event; it’s an opportunity for an organization to identify and develop those areas of their business that need improvement. From this perspective, a complaint just may be one of the most valuable things that your customers can actually do for you.

It’s not unusual for organizations to pay large sums of money to outside consultants, for advice and guidance in determining where their business is failing. While there are countless approaches, methodologies and programs designed to promote such improvement, most have a tendency to gravitate inwards, focusing on internal issues such as the processes involved and their level of efficiency, while under performing in terms of positively affecting outcomes. Paradoxically, from a customer perspective, it’s only the outcome that really matters. How the end result is achieved isn’t a concern to them.

In contrast to the above, customer feedback, however negative it may be, is free of charge and relates directly to the primary concern of the customer – the outcome. It relates to their degree of customer satisfaction. I’ll save my full commentary on this subject for a later article, but needless to say, a satisfied customer is a happy customer, a happy customer is a repeat customer, and a delighted customer is a rich vein for referrals to be mined in the acquisition of new business. While process efficiency is important, it won’t be for long if you don’t have any customers.

When a customer complains, what they’re telling you is that there has been a departure from their requirements; they aren’t happy with the products or services provided by your organization. The fact that your customer is communicating this to you, rather than seeking a new supplier, indicates that the customer is interested in continuing their relationship with you, pending resolution of the issues identified. This is surely better than the customer who quietly walks away and simply “spreads the word” that your products and/or services are substandard.

Best-in-class organizations have realized that complaints form an essential part of their relationship with their customers and understand the importance of this information in the improvement of their products and/or services. They understand that, for the complaint process to be effective there must be a “loop” – a process of communicating-receiving-action. If there is no action when a complaint is received, then the communication you share with your customer is ultimately ineffective. Many organizations have found that by successfully working through an issue with a customer, they can actually grow and nurture their relationship, as such collaboration and partnership leads to greater levels of shared trust and the fulfillment of mutual goals.

I’ve always been amazed at how lesser-performing organizations fail to realize the true importance of customer complaints. I’ve seen organizations refuse to respond to complaints, rather insisting that the customer has expectations that are out-of-line, unreasonable, and/or impractical. Even worse, I’ve seen complaints ignored because the size of the account doesn’t justify the time or action required to address the issue. Sure, it’s up to the discretion of the organization on how to deal with complaints, but remember it’s also up to the customer to determine who to do business with. Customers are looking for suppliers that are responsive to their unique needs and situation. If you’re not actively working to address the needs and concerns of your customers, then you can be assured that your customer is actively looking for an alternative supplier.

http://www.masquality.com

Flying Soon? - Part II

2008-08-14T20:32:00.003-06:00

After writing Flying Soon? I hadn't planned to mention air travel again, but only a day later, here's another news report, this time regarding American Airlines:

http://news.yahoo.com/s/ap/20080814/ap_on_go_ca_st_pe/american_airlines_fine;_ylt=Ary.EEMacU6.BP872xuuoykDW7oF

Mark

http://www.masquality.com

Flying Soon?

2008-08-13T06:54:00.003-06:00

I don't think I have much to add here regarding the relationship between economics and maintenance practices - the articles below speak for themselves.

http://www.chicagobusiness.com/cgi-bin/news.pl?rssFeed=news&id=30535

http://www.odt.co.nz/news/world/17644/quantas-grounds-six-planes-check-maintenance

Mark

http://www.masquality.com

The 33 Strategies of War

2008-07-26T06:14:00.008-06:00

I had mentioned previously that I wasn't going to start of "Book of the Month Club", but here's my recommendation for July. I'm still not planning on doing this on a regular basis, but The 33 Strategies of War, by Rober Greene is good enough to make note of.

It's an excellent read for anyone interested in tatics and strategy, and applies to not only war, but business, life, relationships, etc.

Here's the link to this book, as found on Amazon.com:

http://www.amazon.com/33-Strategies-War-Robert-Greene/dp/0670034576

Mark
http://www.masquality.com

Was Bogus Equipment Sold To Oil Patch?

2008-07-19T07:50:00.005-06:00

I'd be remiss in my blogging if I didn't make note of an issue that happened recently here in Houston. Federal charges were brought against individuals who had sold equipment with counterfeit API monograms.

I caught this on the local news, on KPRC 2: http://www.click2houston.com/news/16885342/detail.html

Mark
http://www.masquality.com

ISO 9001 - You Might Be In Trouble If...

2008-07-16T10:15:00.001-06:00

There are some questions, the answers to which I am unsure...what exactly happened at the end of the TV-series The Sopranos? “Who let the dogs out”? If “it’s not about winning or losing, but how you play the game” - then why bother showing up?

On ISO 9001-related issues, there are answers I am sure of. Several of these relate to ways to tell if there’s going to be a problem during your next ISO 9001 audit.

I’ve decided to make a list of the first 10 of issues that I could think of - not a “Top 10” list, but just the first that come to mind. Since this is being written primarily for companies that have already achieved ISO 9001 certification, I’m leaving out some of the more obvious issues (e.g. missing the six procedures required by the ISO 9001 standard), however, most of these could still apply to an organization attempting certification for the first time.

The first 10 issues I could think of are shown below, presented in the order of the standard (their related clause is shown in parenthesis):

Document Control (4.2.3) - You have multiple versions (revisions) of the same document in use in the work area, or “stray” documents in use without the proper approvals and that haven’t been recorded in the system.

Control of Records (4.2.4) - You can’t find the records you’re looking for, or records that you need when requested. Someone has taken your records and you don’t know who and/or when. If you’re lucky enough to find the records you’re looking for, they’re covered in coffee stains, cigarette burns, and/or food.

Customer Focus (5.2) – You have no customer feedback collected on how you’re performing. If you receive a complaint, it’s taken care of on-the-spot and not documented. You may send out customer surveys or questionnaires, but nobody ever responds.

Quality Policy (5.3) - You don’t have a quality policy posted. It may have fallen off the wall, been taken down, or you may have moved to a new location and forgotten to put it back up.

Quality Objectives (5.4.1) - You have no quality objectives established for the current period, or you have partially developed objectives that use words like “more”, “less, “fewer”, “better”, instead of using quantitative terms. You may have failed to meet your last objectives and didn’t take any subsequent corrective action.

Management Representative (5.5.2) - You don’t have a management representative. Your management representative may have quit, been fired or re-assigned. Worse yet, you may have a management representative that doesn’t know they are the management representative.

Management Review (5.6) - You haven’t performed a management review in over a year. You may have had meetings, but you’re unable to demonstrate anything that comes close to meeting the criteria of the standard.

Competence, Awareness and Training (6.2.2) - You can’t prove the competency of the personnel performing tasks that affect product (or service) quality. You have no established job requirements, and/or you have personnel working and you can’t demonstrate how they’re qualified to do so.

Determination of Requirements related to the product (7.2.1) - You can’t prove any evidence of contract review. Orders may be taken verbally without being documented, or even if taken in writing and there’s no evidence of review.

Design Control (7.3) - Your design controls have lapsed, and now your engineers are free to indulge in their creative pursuits without constraint. Design output isn’t defined, reviews are nonexistent, validation isn’t performed and/or you have no working process to control design changes.

Needless to say, the above is just a sample of the problems that may exist with your Quality Management System (QMS), and it isn’t intended to be an all inclusive list by any means. Since the above list only covers up to clause 7.3 of the ISO 9001 standard, there’s still a lot more that will need to be addressed. You’ll need to perform your own internal assessment prior to your next ISO 9001 certification audit, to identify any other concerns that may exist.

I still don’t know “who let the dogs out?”, but hopefully these answers will help you with your next ISO 9001 audit.

http://www.masquality.com

And Finally...

2008-07-14T14:59:00.003-06:00

Two Six Sigma Black Belts (SSBB's) walk into a board room...

They've been asked by company management to review customer feedback data that's been collected over the past year. Based on a scale of 1 thru 10 (10 is highest), each item scored an average of about 7.5, with the exception of one category: "On-Time Delivery".

The SSBB's reviewed this data, and reported their findings at a follow-up meeting. The first Black Belt explained that, based on statistical testing, he "could not reject the null hypothesis". The second Black Belt chimed in "based on the data, this issue is statistically insignificant".

The company went bankrupt six months later. Their dissatisfied customers had all taken their business to another supplier.

This point of this story isn't about whether "On-Time Delivery" was significant or not. The SSBB's where so absorbed by their methodology that they missed the obvious - the customers were unhappy. The actual issue was that the company averaged only a mere 7.5 out of 10 overall.

Bah-dum-bum.

No actual company was harmed in the writing of this example.

Mark
http://www.masquality.com

ISO 9001:2000 - The Myths (part 1)

2008-07-12T11:59:00.003-06:00

As I was researching topics to write about, I realized that I had several quality manuals (and related procedures) on my desk that I had been asked to review. The systems that these documents described were failures; their development had been contracted out to various individuals by management, with less-than-usable results.

While a few of these systems did initially achieve ISO 9001:2000 certification, they weren't sustainable over the long term. For the most part, what I found were "templates"; the same documents obviously had been used over and over, with just a global name change to match each company they had been sold to (in some cases, even the name change wasn't done very well). These were poorly written; their content ranged from banal to clueless and back to obtuse.

While the content of these documents didn't impress me (at times, I was actually concerned), it did give me an idea for a new topic. With so much misconception and misinformation regarding ISO 9001:2000, I figured I'd take this opportunity address a few common "myths" surrounding the ISO 9001:2000 standard and its requirements:

1. ISO 9001:2000 is for Manufacturing - Any type of organization can benefit from the process-based approach that's defined in the ISO 9001:2000 standard. Equally suited to services as it is to manufacturing, ISO 9001 can be applied to a wide variety of industries and firms, from education to architects, to medical practices, law offices and more.

2. Document Everything - The "Do What You Document, Document What You Do" approach was a cornerstone of ISO 9001:1994, which was all about following procedures. This has since been replaced by a process-based approach in ISO 9001:2000, which emphasizes effectiveness and focusing on the output - the result. The 1994 version of the standard required that 20 elements had to be addressed; the 2000 version requires a minimum of six documented procedures. Anything beyond these six is left to the discretion of the organization, as necessary for the effective control of the organization's processes.

3. Write Exhaustive Procedures - There really are no rules on how to write a procedure. Your procedures don't need to have a section for definitions, normative references, responsibilities, process maps, blah, blah, blah. What they need to do is to be appropriate to the organization and its operational needs. Don't write your procedures solely to satisfy an auditor, but rather consider how to achieve consistency and uniformity of the process under consideration.

4. Record Everything - There are a total of 19 different types of records that are specifically addressed within the ISO 9001 standard. Needless to say, these aren't all of the records that could be generated during the operation of a quality management system, however these particular records are considered essential to its effective operation. If the record of a result or activity isn't required to manage the organization effectively and/or satisfy interested parties, it doesn't need to be maintained.

5. Make a Form for Everything - We've seen forms used in the review other forms, forms that document the fact that a form is needed and even forms used to log and/or track other forms. While certain forms are common to almost every system (calibration forms, audit checklists, NCRs, CARs, etc.), it's important to limit the number of forms used to those that actually add value. Just a hint: there's a direct correlation here with records you need to maintain (see above).

6. Memorize your Quality Policy - This is another example of what I'll call 1994 thinking. Employees need to be trained, to ensure they aware and familiar with the organization's quality policy, and they should be able to locate where it is posted. One of the main reasons it's a written policy that's posted, is so it can referred to as needed.

7. You Need a Quality Manager - ISO 9001:2000 requires the appointment of a Management Representative by management of the organization; it doesn't mention anywhere the need for the position of Quality Manager. There's no reason that the responsibilities for your program can't be delegated between various functions within your organization.

8. A Web-Based QMS is better - I've seen companies that can benefit from such systems, but usually they're large and/or have business units that are geographically separated. Smaller organizations can usually do without such systems. Software solutions can be quite complex, and come with a variety of issues including extensive training requirements, costly hardware updates, constant IT support, and changes to existing work practices. The downside of this approach often negates the benefits of the technology.

9. We can get certified in one month (or even a week!) - The whole purpose of keeping records is to provide evidence of conformity to requirements and the effective operation of the quality management system. Without this history, there's no way that you can demonstrate that your system meets the requirements of the ISO 9001 standard. Regardless of how long your system takes to write, you will need several months of records; walk away from anyone that tells you otherwise.

10. Keep Statistics on Everything - Many organizations go overboard on the data they collect, or think they have to collect. Data is only important if it's actually relevant to the organization, and the effective operation of the quality management system. Don't collect data solely to satisfy an auditor; the organization needs to determine what's important, and measure and collect data accordingly. We've seen extensive SPC programs utilizing the latest computer software, when all the organization really needed was a checklist and a histogram.

The first step in properly documenting a management system is separating myth from fact, with regards to the requirements and the intent of the ISO 9001:2000 standard. There are a lot more myths around than I've been able to list above, but that's an article for another day. Now it's back to my review...

http://www.masquality.com

The Best Choice

2008-06-26T08:36:00.005-06:00

Earlier this month, in Are You the Cheapest or the Best?, I discussed the choice between the cheapest or being the best. Just to briefly continue this thought - given the choice, which would you rather choose (cheapest or best) for each the following?

1. Pediatrician
2. Lawyer
3. CEO
4. Brain Surgeon
5. Accountant
6. Financial Adivsor
7. Oncologist
8. Pilot

When something's important, "best" always wins over cheapest.

Mark
http://www.masquality.com

ISO 9001:2000 - Control of Records

2008-06-24T08:03:00.009-06:00

In order to comply with the ISO 9001:2000 standard, an organization is required to establish a minimum of six documented “system” procedures. The second of these procedures, by order of appearance, covers the Control of Records, and is identified in clause 4.2.4 of the standard as follows:

"Records shall be established and maintained to provide evidence of conformity to requirements and the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records".*

* ISO 9001:2000, Quality management systems – Requirements, Clause 4.2.4., p. 11

What’s a Record?

In order to understand what a record is, we must begin with another standard in the family, ISO 9000:2000, Quality management systems – Fundamentals and vocabulary. In this standard, we find the definition of a record. Simply put, a record is a document, and can be used as an input from one process to another, but in contrast to documents that are purely informative, a record is generated to state results achieved or to provide evidence of activities performed.

It is because of this difference that different rules apply to the control of records than for the control of documents (clause 4.2.3). Records are not issued, revised or tracked by revision. While a record could be amended to reflect new or updated information, the original record would not be affected.

Types of Records

There are a total of 19 different types of records that are specifically addressed within the ISO 9001 standard. Needless to say, this isn’t all of the records that could be generated during the operation of a quality management system, however these particular records are considered essential to its effective operation.

The records that are identified within the ISO 9001 standard are listed below, along with their corresponding clause number (shown in parenthesis):

- Management review records (5.6.1)
- Records of Education, training, skills and experience (6.2.2)
- Records needed to provide evidence that the realization process and resulting product meet requirements (7.1)
- Records related to the review of customer requirements (7.2.2)
- Design and development inputs (7.3.2)
- Design and development review records (7.3.4)
- Design verification records (7.3.5)
- Design validation records (7.3.6)
- Design and development change review records (7.3.7)
- Supplier evaluation records (7.4.1)
- Validation arrangements for processes (7.5.2)
- Product identification records (7.5.3)
- Records related to customer property (7.5.4)
- Calibration and verification records (7.6)
- Internal audit records (8.2.2)
- Product conformity records (8.2.4)
- Records of the nature of nonconformities and any subsequent action taken (8.3)
- Results of Corrective Actions taken (8.5.2)
- Results of Preventative actions taken (8.5.3)

Controls Required

Creating a procedure to meet the requirements established in clause 4.2.4 is a fairly straightforward task. In clause 4.2.4, the ISO 9001 standard provides us with a clear purpose statement, by requiring that the organization ensure that records remain legible, readily identifiable and retrievable. In addition, clause 4.2.4 also identifies what types of controls should be addressed, giving us a basic outline of what needs to be covered in our procedure - record identification, storage, protection, retrieval, retention time and disposition (disposal).

Being given a purpose statement and an outline, the only information we’re missing are the specific controls used by the organization. In this case, the ISO 9001 standard is neither prescriptive nor specific; it leaves the specific controls up to the implementing organization, to define methods that are consistent with its business needs, quality objectives and customer and/or regulatory requirements.

http://www.masquality.com

ISO 9001:2000 - Management Review Q&A

2008-06-17T09:25:00.002-06:00

Earlier this year, when I wrote an article titled ISO 9001:2000 – Your Management Review, I hadn’t realized how much interest there was on the subject. As a result, I’m following up on this earlier article with a simple Question and Answer (Q&A) session, which is based on the questions I’m most frequently asked:

Q1: Is a Management Review a formal meeting?

A1: A management review is appropriately named, as it’s an opportunity for top management of an organization to review the performance of their organization’s management system. It’s more than just a meeting however, as a management review includes the collection, analysis and review of performance data, and any decisions and actions related to the results.

Q2: Can a management review be held remotely?

A2: With the technology that is currently available, there’s no reason that telephone and web conferencing shouldn’t be considered. Portions of the review can be performed remotely when it is not possible or cost effective to meet in person. Data can be collected and analyzed electronically, and the results communicated by email or other means.

Q3: Our organization is quite large and geographically dispersed. How can we perform a single management review?

A3: There’s actually nothing in the standard that requires only one management review be performed. For a large organization, this review can be performed at individual levels (or locations) and then consolidated into a final review that is performed by executive management of the organization.

Q4: This is our first management review and we don’t have much information to report. Can we still hold a management review?

A4: You have information to report; the problem is that you just don’t have much data. This in itself is noteworthy, and should also be considered as an opportunity for improving the effectiveness of your quality management system under section 5.6.3 of the ISO 9001:2000 standard (Review Output).

Q5: What is the required interval for management reviews?

A5: The ISO 9001 standard doesn’t specify any specific time frame, other than requiring these reviews to be performed at planned intervals. For a “new” program, I would recommend at least quarterly, and then adjusting the duration to possibly six months or even on an annual basis if this meets the needs of the organization. Personally, I would never go longer than a 12 mo. interval between reviews.

Q6: Prior to implementing ISO 9001:2000, our organization held monthly meetings to review the performance of our organization. While these meetings wouldn’t meet the requirements of the ISO 9001 standard, they were of considerable value to us. Will this need to be changed?

A6: The answer is no. There’s no reason to change what you’re already doing, particularly if it works well for you. I would keep minutes for these meetings however, and use these as a source of review input for when the organization does hold a formal management review.

Q7: Section 5.4.1. of the ISO 9001:2000 standard requires that Quality Objectives are established at relevant functions and levels within the organization. Is the Management Review an appropriate time to address this?

A7: I personally recommend this. The management review is an ideal time to address your organization’s performance towards meeting existing objectives, and for determining new or revised objectives for the upcoming review period.

Q8: What types of records do we need to maintain?

A8: You’ll need to retain records that demonstrate the requirements of the ISO 9001 standard have been met. This should include, as applicable, meeting minutes (dates, attendees, location, agenda, etc.), objective evidence used as part of this review, and any decisions and actions that result (including responsibilities and timelines).

http://www.masquality.com

Purple Cow

2008-06-16T10:54:00.005-06:00

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Mark

http://www.masquality.com