Context of the Organization – External Issues

external influencesContext of the Organization – External Issues

External Issues Relationship to the Company Scope

The scope of the company explains what the company does and doesn’t do. If it is a steel stamping shop it is unlikely the company also makes cotton candy. If you manufacture parts for a specific industry, your company may not do any design and development. Scope talks about what products and services the company provides. Internal issues are within the company’s control. External issues are usually outside the company’s control. With external issues all the company can do is monitor and react, it cannot control the issues.

External Issues Models

Models used in strategic planning or market research are useful in identifying external issues. There are a large number of models available. One that is effective is PESTEL but any model that allows the company to identify external issues and define how to monitor and react to them can be used.

External Issues Using PESTEL

PESTEL stands for

  • Political – taxes, tariffs, labor laws, trade restriction
  • Economic – economic growth, interest rates, exchange rates, inflation
  • Social – population growth, age distribution, attitudes toward careers and minorities, safety concerns
  • Technological – R&D activity, automation, rate of change, production efficiency
  • Environmental – weather, climate
  • Legal – discrimination, consumer, employment, health and safety, consumer law

Risks and Opportunities with External Issues

The following table shows some examples of an issue, a single concern, the potential risks and opportunities and a method of monitoring them. Most companies will have multiple concerns for each issue.

Issue Concern Risk Opportunity Monitor
Political Tariffs Reduces ability to export Reduces external competition Monitor USITC
Economic Interest rates Limit capital availability Increase capital availability Meet with bank quarterly
Social Aging population Smaller workforce Increased demand for certain products Strategic planning and Annual Management review
Technological Changing markets No demand for current products Large demand for innovation Industry specific information sources
Environmental New laws Require investment Provide new markets Monitor EPA regulations quarterly
Legal Consumer laws Increased cost to manufacture Limits new competition Set google alerts
Style Communication Poor Excellent In-process errors

 

Conclusion – External Issues

The risks and opportunities of external issues can be handled in a very similar manner to internal issues. A key difference between the two is how much control the company has. With internal issues the company management should be able to evaluate and adjust to influence or change the outcome. With external issues the company can only react to the issues.

By looking at the Interested Parties, Internal Issues and External Issues a company can have a better understanding of the business risks and opportunities. With this information they can select a strategic plan which best directs the company to obtain a long-term goal of profitability and longevity.

 

Interested Parties

Management requires everyone to work together for quality

Management requires everyone to work together for quality

Context of the Organization – Interested Parties

This is one way of looking at Interested Parties. Other consultants look at it differently. You need to decide what works best in your company.

Scope, requirement hasn’t changed, Assume you reviewed it and it accurately represents your organization

Who are the interested parties?

This changes from company to company only you can determine who the interested parties are. In previous revisions of ISO we were mostly concerned with  the customer with some interest in our suppliers and our employees. But nothing was formalized and there wasn’t a direct consideration of risk/opportunity.

¡  People who have a stake in what and how your organization performs in producing products or services which meet the customers’ requirements

¡  Are relevant to the QMS

While section 4.2 of the ISO 9001:2015 standard does not require you to identify the risks and opportunities, they should be included in section 6.1. So we’ll go over that now and save repetition later.

Risk negative or positive, ISO 31000, 14001 opportunity, Interested Parties can be both

Here is a side point in ISO 9001 risk is considered to be either negative or positive. In ISO 31000 and ISO 14001 they consider risk as negative and opportunity as positive. Keep that point in the back of your mind in-case an auditor challenges the term “opportunity” and be prepared to say in your company opportunity means positive risk. You can use whatever name you want. I have a client who names quality objectives as “rocks”. It is a term everyone there knows and understands and it meets the standards requirements for quality objectives so the auditors don’t challenge the name.

Interested Parties effect the QMS

Interested parties effect the QMS. This is important because this may or may not include the customer, the end users and your competitors.

One way to look for Interested Parties is to consider the  following areas. Again you may not have all of these and you may think of some not included in this presentation. It is up to you to identify the interested parties for your company.

  • Suppliers – Providers of raw material, components, sub-assemblies, finished product and services
  • Internal groups – Employees, unions, stock holders, management
  • Intermediaries – The most common is a distributor but there are also aftermarket service groups
  • Alliances – A bank may recommend a consultant they think will increase the company’s profitability, while the consultant may recommend a bank to clients who are having banking issues
  • Influencers – Think of peer groups, councils, chambers of commerce

Organizing Interested Parties

There is more to be done than just list the interested parties. Some of the interested parties can provide both a risk and an opportunity. For example a supplier performance issue presents a risk to you meeting your customers’ requirements. However, if they are a leader in their industry they could provide you with a competitive advantage with a new product none of your competitors has access to use.

Slide 10 – Risks and opportunities

So let’s start the table.

Interested Party Concern Risk Opportunity
Suppliers Their reputation and quality/delivery/price influences yours Nonconformance Superior performance
Employees Is it stable? Do they have pride of workmanship? Controls product quality Source of innovation
Shareholders Source of investments, company direction Looking for short term ROI Supports re-investing
Community Impact on your reputation, and ability to produce Demands which reduce profits Promotes development
Intermediaries Increased sales, impacts your reputation Damage to product More contacts/sales
Alliances Increased opportunities, concerns for reputation Your reputation is tied to theirs Increased sales
Interested party Concern Risk Opportunity
Influencers Is their advice of value Different frame of reference Wide range of experience
Regulators Compliance Not managing changes Good rating
Certifying bodies  Do they understand the organization and the standard(s) Dependent on auditor training Global view of QMS

 

You get the idea.

Controlling Risk from Interested Parties

Now that you have a list of your interested parties and the concern or impact they have on your company with the inherent risks or opportunities, you need to monitor and control your risk and capitalize on your opportunities. So let’s add a column.

Interested Party Risk Opportunity Monitor
Suppliers Nonconformance Superior performance Annual performance review/ random inspection
Employees Controls product quality Source of innovation Annual performance review
Shareholders Looking for short term ROI Supports re-investing Review BOD reports
Community Demands which reduce profits Promotes development Community newsletters, membership in community organizations
Intermediaries Damage to product More contacts/sales Reports of NC and Sales
Alliances Your reputation is tied to theirs Increased sales Monitor press releases Qtrly Sales
Influencers Different frame of reference Wide range of experience Monthly meetings
Regulators Not managing changes Good rating Regulator updates/ ratings
Certifying bodies Dependent on auditor training Global view of QMS Annual surveillance audit

 

 

Of course these controls are typical examples and you should define what works for your company. The point is you should have a way to monitor and address risk and capitalize on opportunities.

Documenting Interested Parties

When the auditor arrives they are going to ask, “Who are your interested parties?” There is no requirement in the standard that you list interested parties.

You must communicate to your organization who are the interested parties and how they will be monitored.

So when identifying Interested Parties think about who affects or has the potential to affect your QMS

Let your common sense guide you on identifying the Interested Parties, Don’t worry, you can do this. If you need help, e-mail me at technacon1986@sbcglobal.net or call (708) 814-3685.

The next presentations will be on internal and external influences.

Documented Information

Can we throw out our procedures or are we still locked in?

Can we throw out our procedures or are we still locked in?

ISO 9001:2015 and Documented Information

The first thing we heard about ISO 9001:2015 version was no more need for procedures, quality manuals or records. Hurray, hold a bonfire in the parking lot!

Hold the matches. We now have documented information in place of procedures, manuals and records. So is this an “I gotcha” on the part of ISO?

Not necessarily. Jump into the standard at section 7.4 Communication which says “The organization [your company] shall determine the internal and external communications relevant to the quality management system, including:

  1. a) on what it will communicate;
  2. b) when to communicate;
  3. c) with whom to communicate;
  4. d) how to communicate;
  5. e) who communicates.

This gives the company the leeway to communicate in manners other than written procedures. For example instead of having a Work Instruction on how to assemble a product or complete a form, the company could have a video employees could reference instead.

Where is Documented Information required?

In the ISO 9001:2008 there are 6 documented procedures. That is all you needed. So what about the 2015 revision?

Thumbing through the standard I found a requirement for documented information as follows:

  • 4.3 Determining the scope of the quality management system – “The scope of the organization’s quality management system shall be available and be maintained as documented information”
  • 4.4.2 To the extent necessary, the organization shall:

o   maintain documented information to support the operation of its process

o   retain documented information to have confidence that the processes are being carried out as planned

  • 5.2.2 Communicating the quality policy – “The quality policy shall be available and maintained as documented information
  • 6.2.1 Quality objectives and planning to achieve them – The organization shall maintain documented information on the quality objectives.
  • 7.1.5.1 General [Monitoring and measuring resources] -The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.
  • 7.2 Competence d) Retain appropriate documented information as evidence of competence
  • 7.5.1 General [Documented Information] –The organization’s quality management system shall include documented information required by this International Standard and documented information determined by the organization as being necessary for the effectiveness of the quality management system
  • 7.5.3.1 [Control of documented information]Documented information required by the quality management system and by this International Standard shall be controlled…..
  • 7.5.3.2 [Control of documented information]Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and be controlled.
  • 8.1 Operational planning and control e)1) and 2) -The organization shall plan, implement and control the processes needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6 by: determining, maintaining and retaining documented information to the extent necessary to have confidence the processes have been carried out as planned and to demonstrate the conformity of products and services to their requirements
  • 8.2.3.2 [Review of the requirements for products and services] – The organization shall retain documented information as applicable on the results of the review and on any new requirements for the products and services.
  • 8.3.2 Design and development planning j) – the documented information needed to demonstrate that the design and development requirements have been met.
  • 8.3.3 Design and development inputs – The organization shall retain documented information on design and development inputs
  • 8.3.4 Design and development controls f) – The organization shall apply controls to the design and development process to ensure that documented information of these activities [a-e] is retained
  • 8.3.5 Design and development outputs – The organization shall retain documented information on design and development outputs
  • 8.3.6 Design and development changes – The organization shall retain documented information on design and development changes and the results of reviews and the authorization of the changes and the actions taken to prevent adverse impacts
  • 8.4.1 General [Control of externally provided processes, products and services] – The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers based on their ability to provide processes or products and services in accordance with the requirement. The organization shall retain documented information of these activities and any necessary actions arising from their evaluations.
  • 8.5.1 Control of production and service provision a) – Controlled conditions shall include, as applicable the availability of documented information that defines the characteristics of the products to be produced, the services to be provided, or the activities to be performed and the results to be achieved;
  • 8.5.2 Identification and traceability – The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability.
  • 8.5.3 Property belonging to customers or external providers – When the property of a customer or external provider is lost, damaged, or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documented information on what has occurred.
  • 8.5.6 Control of changes – The organization shall retain documented information describing the  results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.
  • 8.6 Release of products and services -The organization shall retain documented information on the release of products and services. The documented information shall include evidence of conformity with the acceptance criteria and traceability to the person (s) authorizing the release.
  • 8.7.2 [Control of non-conforming outputs] – The organization shall retain documented information that describes the nonconformity, describes the actions taken, describes and concessions obtained, and identifies the authority deciding the action in respect of the non-conformity.
  • 9.1.1 General [Monitoring, measurement, analysis and evaluation] – The organization shall retain appropriate documented information as evidence of the results.
  • 9.2.2 [Internal audits] – The organization shall retain documented information as evidence for the implementation of the audit program and the audit results.
  • 9.3.3 Management review outputs – The organization shall retain documented information as evidence of the results of management reviews.
  • 10.2.2 [Nonconformity and corrective action] – The organization shall retain documented information as evidence of the nature of the nonconformities and any subsequent actions taken and the results of corrective action.

              Whew! That was a lot of documented information, about 30 by my count. So what does this mean, do we need 30 procedures now instead of six or zero as some consultants are claiming?

The Clues as to What to do for Documented Information

Retain Documented Information

First look for the word “retain” before documented information. In most cases this was a “record” in the 2008 version and about 2/3 of the referenced documented information requires information be retained.

If you have an ERP system or a design program or a project program or a database program which automatically retains information such as product test results and release authority there is no need for a procedure or manual directing you to save the data, your system does this for you. If there is not an automated system than there must be some way to communicate, “save this stuff this way”. Does it need to be a procedure? No, but a procedure may be the simplest and easiest method of communication.

The Other 1/3

So let’s look at the other 10 or so requirements of documented information.

  • Scope of the quality management system (QMS). Hopefully your QMS is part of the company’s strategic planning, if not there are some more basic issues going on which need to be addressed first. So the scope could be part of the strategic plan. It could also be addressed in a risk/opportunity matrix. Or it could simply be part of the company quality manual. Many companies will need to continue to provide a quality manual because it is a customer requirement. Do they need to regurgitate the standard? No. Put in them the information the standard and your customers require. Organize it to make sense to you, your customers, employees, regulators and any other interested party your company has identified.
  • The quality policy is documented information. It can be posted throughout the company via electronic message boards or bulletin boards. Ta da! You’ve got it. Of course the company will want to note which bulletin boards have it in case of an update, not all companies have electronic message boards.
  • Quality objectives and planning to achieve them should already be in place. An easy way to maintain them is with a project program like Basecamp. However, such a program isn’t necessary. It can simply be part of the management review minutes.
  • Information required by the standard and the organization must be controlled. This includes documents of external origin. So if there is data or communications which is vital to your QMS or that the standard tells the company it must have, it needs to exist and be protected against unauthorized changes. What this information is and how it is to be handled must be communicated. So if a video works, great. If a procedure is the answer, great. If the information is a regulation or a statute  than a link to the source of the information may be effective.
  • Documented information that the design requirements have been met will include specifications and drawings and records of design reviews. Again, this may be done with a specific program or communicated with a procedure.
  • Control of externally supplied products and services requires retained documented information about how suppliers are managed, evaluated and controlled. It is important to suppliers to have this information as well as retaining documented information so a system must be in place to control suppliers. A video might do a good job of explaining this or an e-mail or a procedure.

Summary

While procedures are no longer required, they may be the easiest and clearest form of communication for the who, what, where, when, why, and how of an activity. It is acceptable to have new and innovative ideas to communicate and retain documented information. So let’s hear your input. If you didn’t have to have a procedure how would you handle documented information?

How Come Hardly Anything Ever Gets Better? The Case for Quality Improvement.

How do you create quality improvement?

Quality Improvement from the Quality College

In 1987, I had the privilege to attend the Quality College in Winter Park, FL. It was a highly informative week and I have kept the binder and used it as a reference ever since, although I haven’t gone back to it for a few years.

When I started to develop a page for the teachings of Philip Crosby I pulled out the binder and reviewed the material. Near the back I found a letter from Philip Crosby titled “How come hardly anything ever gets better?” A similar question was posted on LinkedIn so it seemed a good place to start.

Mr. Crosby’s first point was that no one, not the powerful or the powerless were against quality improvement. All of his books, speeches and educational material showed the financial fact that doing things right the first time cost less than doing things wrong and fixing them. Products, services, prisons, morals, the judiciary, Congress, movies, taxis – just about everything needs improvement.

Since everyone was in favor of improvement and opportunities abound, there should be an epidemic of things getting better. That begged the question; why is hardly anything getting better?

Who is Responsible for Quality Improvement?

Mr. Crosby came up with 3 basic reasons:

  1. The highest paid and most talented people in a company do not work on improvement. They produce strategy books, planning manuals, marketing reports, five year plans etc that are shown like merit badges but are not used or implemented. Everyone is working hard on things that make little difference.
  2. People who understand a subject do not get help in determining a policy for improvement. Nationally known consumer advocate groups have no experience in quality management. Most business media experts talk about quality and yet their experience is limited. Getting a common definition of “quality” would be difficult and it has been overlaid with emotion.
  3. 3.      Management and labor do not understand each other. There are very few members of management that have ever actually done the work they supervise. Motivation of the workers is the most popular theme for quality improvement programs. Yet it is management that needs to realize they are the cause of the problems by the way they manage. Union management falls into the same boat as company executives.

The Results of Quality Improvement

Companies that create a renaissance in terms of changing management operating attitudes have drastically improved their products and services and reaped the reward to the bottom line. Companies have already paid for quality, isn’t it time they should get what is coming to them?

Has There Been Quality Improvement?

As I read the letter in many ways I agreed with Mr. Crosby. However looking back over the past 25 years, I also realized that we have come a very long way in large part thanks to Mr. Crosby, Dr. Deming, Dr Juran and Dr. Shewhart. So I invite you to comment. What improvements have you seen? Are things getting better or is hardly anything getting better?

What Does ISO Stand For?

ISO means working together for standardization

Where Did the Name ISO Come From?

ISO is the anachronism for “International Organization for Standardization”. It is not the” International Standards Organization”. The anachronism would have been different in each country – IOS in English, OIN in French. To avoid any problems this would create the founders gave it a short, all-purpose name. They chose “ISO” from the Greek isos meaning “equal”. So whatever the country or language, the short form is always ISO.

What does the ISO do?

The International Organization for Standardization is the world’s largest developer and publisher of international standards. Did you ever wonder who came up the with standard size of a sea-tainer or a tablet of paper? It was the International Organization for Standardization. Most of the time we don’t think about standards, we just expect things to fit and to work well and safely. Standards are hidden given only noticed when absent. The International Organization for Standardization has more than 19,000 international standards. The International Standards provide a common technological language facilitating trade and the transfer of technology.

How Did ISO Get Started?

In 1946 delegates from 25 countries met and decided to create a new international organization with the objective “to facilitate the international coordination and unification of industrial standards”. It officially began operations February 23, 1947. It is not a governmental organization but a network of 163 countries, one member per country, with the central secretary in Geneva, Switzerland that coordinates the system.  Some the members are part of their government structure, others are from the private sector, usually from a national partnership of industry associations. Each member has one vote and all members are on equal footing. Standards are based on consensus among experts in the field and are periodically reviewed, usually every five years to see if they should be maintained, updated, or withdrawn. The standards are voluntary and market driven. There is no legal authority to enforce the implementation of the standards.

How Are ISO 9001, ISO 14001, ISO 27001, ISO 26001 Different?

The majority of the standards are specific to a particular product, material or process. However ISO 9001 (Quality), ISO 14001 (Environmental management), ISO 27001 (information security) and ISO 26001 (social responsibility)are generic management system that can be implemented in any organization, no matter the size, product or sector.

If you would like to learn about how International Organization for Standardization is financed and new standards are selected for development go to http://www.iso.org/iso/about.htm

 

Point 11 – Arbitrary Numerical Targets

 

Is your management review a continuous improvement tool or an arbitrary numerical target?

Management Review – a Continuous Improvement Tool or Generator of Arbitrary Numerical Targets

 

Eliminate arbitrary numerical targets
Eliminate work standards that prescribe quotas for the work force and numerical goals for people in management. Substitute aids and helpful leadership in order to achieve continual improvement of quality and productivity.
Dr. W. Edwards Deming

Doing it Wrong – Management by Arbitrary Numerical Targets

I think the key phrase is “arbitrary numerical targets”. Various companies I
worked for over the years have had management goals and objectives. Sometimes
the managers chose them, sometimes we were guided in them, and at a few it was
just an outright order. At one particular company we had to find either a 10%
increase in productivity or a 10% reduction in costs each year. To the outside
world we were setting our own goals. In reality we were working to arbitrary
numerical targets. The glossy projection sheets and plans appeared to be the
desires of a motivated workforce. We were motivated alright, we either
delivered on the arbitrary numerical target or lost our jobs.
The reason these goals were arbitrary numerical targets was they were identified
using the wrong method. Management did not sit in the management review and
look at the reported performance, and ask the staff to participate in continuous improvement. They looked at how much money they needed to bring in
to be a hero and then told everyone to deliver on arbitrary numerical targets.

Doing it Right – Management by Continuous Improvement not Arbitrary Numerical Targets

There was one company I worked for that did this right. They decided, from the data
in the management review, which was the worst performing press in the plant. It
was one of those bad economic times and no one had money to replace the
machine. Management built a team of operators, mechanics, supervisors and
engineers and turned the machine over to them. They didn’t set an arbitrary
numerical goal, they asked “what would you do to make this run better?”
The team cleaned the machine and then ran an order. Any place there was an oil leak,
they fixed it. They figured out why the leak had occurred in the first place
and where necessary made improvements in replacement parts like bearings and
seals. Once the machine was functioning as designed, they implemented the
Plan-Do-Check-Act process. They analyzed the production on the next order and
tweaked the machine and tooling. They adjusted gages so they were easy to read
and ran another order. By the time they got through, the machine was producing
at 130% of design with a part-time operator. No arbitrary numerical target
would have set the goal this team achieved.

Which Way Are You – Management Review to Eliminate Arbitrary Numerical Targets

A key tool in eliminating arbitrary numerical targets is the management review. If done well, it leads to aiding the improvement of quality and productivity. If done poorly it leads to arbitrary numerical goals. Look at how the process is managed. Are reports put into place to pass the audit or are they a tool to identifying problems and solutions? Who contributes to the reports? Is this a “dog and pony show” or are
employees encouraged to talk openly without fear of losing their jobs? If a
company wishes to create continuous improvement, to stay in business and create
jobs, then the first place they need to look is the management review. So what
does your management review generate; continuous improvement or arbitrary
numerical targets?

Creating and Maintaining a Corporate Culture Using ISO 9001

 

How do we maintain and communicate corporate culture using ISO 9001?

                I have a Saturday morning secret weapon, to improve my business. I attend the Levy Entrepreneurial Group meeting. Thank you Joe for creating it, Jack and Terry for leading it, and Don for introducing me to it. I love talking to the attendees, they have so much experience and they are happy to share.  Subjects range beyond my imagination, no small feat when you realize I write fiction as a hobby. On the drive home, this week’s meeting  on corporate culture, had my mind running like a squirrel that got into chocolate covered coffee beans. Good thing traffic was light, I was definitely a distracted driver.

                Let’s start by defining corporate culture. It is the psychology, attitudes and experiences of the society formed in a company. It is a blend of values, beliefs, rituals and myths, developed over time. To sum up, corporate culture is the perception of a company by its’ employees, vendors, and clients.

                So how do we create and keep a positive corporate culture? Implementing ISO 9001 correctly.

Communicating Corporate Culture using ISO 9001

It starts with the Quality Policy. It is a simple, straight forward statement of how we treat the customer, our employees and our suppliers. It must be something more than a framed plaque on the break room wall. Company leaders, and that is anyone who supervises, trains, or assists other employees, must live and refer to the values stated in the policy when it comes to decision-making. Thus a requirement of ISO 9001 is communicating the corporate culture.

                Job descriptions also communicate the corporate culture in more subtle ways and are required by ISO 9001. The job descriptions guide the employee to work within specific constraints and include a responsibility to evaluate and improve how the company does business. This should also be reflected in the employee review process and the development of objectives. All of these are requirements of ISO 9001. All of these communicate the corporate culture.

                Using the standard organizes communications to the employees. Clearly defining the corporate culture using ISO 9001 provides consistent values as different people generate job descriptions, reviews and other employee documents since everyone is guided by the quality policy.

                Small companies often do a good job of “presenting the vision” when they start. Growth can change all of that. Training is necessary. Not just job training but also training on the corporate culture. Much of Saturday’s meeting included examples of when this was done well and when this was done poorly. The standard requires the training on the quality policy which defines the corporate culture. Using ISO 9001 requires the communication of the corporate values.

Keeping the Corporate Culture Using ISO 9001

                Documentation  

                When developing your documentation systems it is critical to realize everything is linked and the quality policy it the keystone holding the over arching philosophy together. Using the standard as a guide helps control the dispersal through the documentation process, making it easier to communicate the corporate culture using ISO 9001.

Section 4.2 of the ISO 9001 standard lists the documents a company needs to use for training to keep the corporate culture in place:

  • A quality policy and objectives
  • A quality manual
  • Procedures
  • And documents for planning, operation and control of the processes

All of these must reflect the corporate culture, particularly when it comes to guidance on decision making.

                Management

                According to section 5.1 of the standard, management must accept the responsibility to keep the values important to the corporate culture in place. A key element to keeping corporate culture is stated in clause 5.5.1 of the ISO 9001 standard, “Top management shall ensure responsibilities and authorities are defined and communicated within the organization.” That isn’t just guidelines on who does what and with what and to whom, but also the values guiding each and every interaction, decision and activity in the workplace.

Viewing Employees as a Resource Stabilizes the Corporate Culture using ISO 9001

                ISO 9001  has a whole section on employees. How does management make sure they are competent, aware of the corporate culture, and trained? Does the corporation provide the infrastructure and work environment to make the employees successful at living the corporate culture? Most importantly, the standard recognizes employees are a valuable resource. Section 6 of the standard is a guide to empowering employees. It becomes a simple task to stabilize the corporate culture using ISO 9001.

Outside perceptions of the Corporate Culture using ISO 9001

                The Care and Feeding of Clients

                ISO 9001 requires interaction with the client and a development of a feedback mechanism, not only for errors but in ways to provide better service. The corporate culture has to be built around serving the customer or the company doesn’t stay in business. Thus the clients perception  is improved and the corporate culture using ISO 9001 is propagated.

                Controlling vendors

                Most companies focus on communicating and living their corporate culture  when it comes to their clients and their employees. A much smaller number take the same care to communicate the corporate culture to their suppliers. Implementing ISO 9001 addresses that shortfall. The supplier must have a good perception of how the company expects them to perform and clear communication as to whether these requirements have been met. This goes beyond, meeting performance requirements, on-time delivery, and reasonable price. Consistency is created through the entire process stream and clear perceptions created of the corporate culture using ISO 9001 to deal with suppliers.

                How the standard is viewed and implemented can take many forms. However, creating and maintaining the corporate culture using ISO 9001 is one of the strengths of doing the job right, staying in business and providing jobs.

ISO 9001 Management Review – Going in Circles

Are We Going in Circles ?ISO 9001 Management Review

Implementing ISO 9001 can sometimes feel like you are a dog chasing its’ tail; you can’t just walk down through the standard completing  a section at a time. Instead you have to jump from quality policy to documentation to customer requirements to design and hey isn’t this all about process control? Talk about making us linear, engineering-types crazy with frustration.

ISO 9001 Management Review is really a two-way Street

ISO 90010 management review is a key element in making implementation of the standard a viable continuous improvement effort. Support for change comes from the top down and is communicated in the ISO 9001 management review. Management is responsible for making sure the resources are available to create change. Management is responsible for setting priorities for change. ISO 9001 management review is the place where employees demonstrate what is and isn’t working and conveys to management what they need to accomplish positive change. ISO 9001 management review is the place to communicate and set the goals for the next business cycle, so while it may feel like you are going in circles it is really a two-way street for communication.

Typically, the management representative pulls all the information together for the ISO 9001 management review and generates the agenda for the business cycle. Note, it should be for the business cycle. In most companies the business cycle is annually so a single ISO 9001 management review per year suffices. However, I have seen companies where the business actually cycles multiple times a year. In this case, for the ISO 9001 management review to be an effective tool, and not just “the ISO 9001 standard requires it so we have to sit through it” meeting, it should be performed multiple times per year.

The management representative is responsible for keeping the presentation on track, but that does not mean doing the entire ISO 9001 management review, single-handedly. Each area should report and take full responsibility for the presentation of the data and answer questions related to that data.

Organizing the ISO 9001 Management Review

The data being presented at the ISO 9001 management review should not come as a surprise to management. They should have been receiving, and reading, regular updates. This meeting is to present trends from the data to be used to guide future actions and goals and most importantly, determine if the system is working or needs serious revision.

Each activity in standard implementation should link back to and communicate to management through the ISO 9001 management review. The ultimate responsibility of management is to allocate resources, develop a plan to be competitive, to stay in business and to provide jobs. For this reason, during implementation of the ISO 9001 standard it sometimes feels like the efforts take the employees in circles, always returning to the ISO 9001 management review. Continuous improvement is a cycle and a never ending quest following the Plan Do Check Act model. ISO 9001 is a tool for continuous improvement and therefore is cyclical in nature. ISO 9001 management review is the two-way street for communication to create constancy of purpose for continual improvement of products and service to society, allocating resources to provide for long range needs rather than only short term profitability, with a plan to become competitive, to stay in business, and to provide jobs[1].


[1] Dr. W. Edward Deming, 14 Points, “Constancy of purpose”

Point 9 – Are You Talking to Me?

Break down barriers

Break down barriers between departments and staff areas. People in different areas, such as Leasing, Maintenance, Administration, must work in teams to tackle problems that may be encountered with products or service.

Dr. W. Edward Deming

If you every want to see a head butting contest, put an experienced tool and die maker with a freshly graduated tooling engineer. If you don’t have a vested interest it can be entertaining. Certainly, I found it significantly enlarged my four letter word vocabulary.

The company faced an unacceptable defect level being generated from the tool. Root cause analysis guide us to a poor understanding, and therefore almost non-existent communication, between engineers and the tool makers. Each vocally attributed the problem to the other.

Our solution, have them trade positions for a day. The engineer got his hands dirty and once he got over being self-conscious actually had some fun running mills, lathes and all the other toys the tool maker used. The tool maker got to try his hand at CAD and got an earful of just how little information the engineer had to work with. Each came away from the project with respect for the other and the freedom to communicate instead of blame.

We started a program having new hire engineers working in the tool room and training toolmakers on the engineer’s toys. Each learned to respect the other. The groups went from snubbing each other in the lunch room to wearing a path in the floor tile between each others’ work stations.

Our next step introduced Failure Mode and Effect Analysis (FMEA). We now had people who were willing to work together instead of point fingers. As soon as we armed them with data and invited them to utilize their education and experience our quality made a geometric improvement. Where 3 sigma had been an unrealistic dream, we made the jump to 6 sigma and parts per million defect levels.

This break though came because we broke down barriers, increasing respect and communications. If we had started the FMEA without first developing respect between the participants our success would have been minimal.

Where are the communication barriers in your company?

Point 5 – Improve Every Process

Improve every process

Improve constantly and forever every process for planning, production, and service. Search continually for problems in order to improve every activity in the company, to improve quality and productivity, and thus to constantly decrease costs. Institute innovation and constant improvement of product, service, and process. It is management’s job to work continually on the system (design, incoming materials, maintenance, improvement of machines, supervision, training, retraining).

Dr. W. Edward Deming

Improve constantly and forever, Wow, that is a tall order. Larger companies are able to staff for improvement, but what can the little guy do?

The first step is to prioritize, go for the biggest bang for the investment first. That does mean collecting data. Start with a Cost of Quality report. How much do you scrap? How much do you spend on rework?

When I go into plants to implement ISO9001 I expect to get them certified in system that is indicative of the company culture but I also look for where there is waste and I can reduce costs. I take a visit to the scrap bin and here is the trick, I look for similar parts with similar defects. This tells me there is a system failure. It can come from two places, the design of the part or the method of manufacture. I work backwards from the parts and look to save my client the annualized cost of my contract.

Service providers are a little different. There is no scrap box to look in. What I generally find with them is each employee has a different way of doing each job and there are no written directions or procedures. Each person is sure their way is best. Frequently they have found out about a customer problem and have incorporated a preventive measure in their own method. By listening and applying this information and then training the entire staff, making sure to acknowledge the source and reason for the preventive measure we create a streamline system that addresses all customer issues. We have searched out the problems and created improvement.

Both the manufacturer and the service provider do have customers. Both have complaints that can be used to create real and systematic improvement. Both have the opportunity to call their customers and really listen to what the customer wants and needs. A requirement of ISO 9000 is continuous improvement. The companies that deliver on that element grow.

My bank is ISO 9000 certified. I talked to one manager and he said the certification didn’t mean much to the average customer. What did make a difference was the consistency of accurate and reliable performance, from both new and long time employees. The customers found the bank listened to them and implementing safe new systems that made banking easier at no charge. ISO 9000 had created a system of continuous improvement that kept and drew in new customers. The bank has been able to stay in business, loan money and provide jobs. To quote the good Doctor, “So simple”.