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?

Fitness for Use

Quality is fitness for use

Quality is fitness for use

Fitness for Use Categories

Dr Juran defined a non-conformance or reject or defect as “unfit for use”. Parts could be broken into one of four categories:

  • Fit for use and conforming to specification
  • Fit for use but not conforming to specifications
  • Not fit for use but conforming to specifications
  • Not fit for use, not conforming to specifications

Conforming to Specifications Not conforming to   specifications
Fit for use   These are no problem – no action is required This causes seriousInternal communications   problems
Not fit for use   This causes serious External communications   problems These are no problem – no action is required

 

Fitness for Use = Specifications

In two of the four categories, the specifications are useful. The supplier and the customer agree and the customer always get product that they want. When the parts are fit for use and conform to specifications product ships and everyone is happy. In the same way, if the product is not fit for use and does not meet the specification, the supplier will incur a cost but not lose a customer. Everyone is in agreement.

Fitness for Use≠ Specifications

Two of the categories generally lead to a level of (sometimes) controlled chaos. When the parts are fit for use but fail to meet the specification the specifications need to be changed. Understand fitness for use does not mean a product that will function but is cosmetically unsatisfactory. This product meets all the needs of the customer and they see no difference between these products and what they normally receive. Internal communications and conflict will occur until the specifications are revised.

The other category should be considered catastrophic for the supplier. The product does NOT meet the customer’s needs but the supplier views it as conforming to specification, or satisfactory product. It is here that a root cause analysis and long term preventive action is needed.

Controlling Specifications Controls Fitness for Use

Specifications are key documents for training and communication. The customer either sends their specifications or orders a catalog cut which defines the product performance. The first key step to controlling quality starts at Sales. When they take the order, they must understand and communicate the customer needs. If the customer does not what variations in color greater than .5 microns, sales must communicate this back to engineering. Engineering and manufacturing must look at the specifications and their process capability and decide of the specifications can be met. If not they must communicate back to Sales to negotiate a solution.

Clear communication at the start of the process which defines what can and cannot be done is the first step to good quality product, a satisfied customer, and a profit for the supplier.

 

Quality Management

Management requires everyone to work together for quality
Management requires everyone to work together for quality

A Fundamental Concept for Quality Management

Dr. Joseph M. Juran taught that quality management used the same three processes as financial management. They are:

  • Quality Planning
  • Quality Control
  • Quality Improvement

Quality Management – Quality Planning

Of the three elements, inadequate quality planning is a major source of quality deficiencies. Many of the remedies for quality improvement projects consist of re-planning quality. The best way to deal with poor quality is to prevent it in the first place. The earlier in the process a cause of poor quality can be removed the lower the cost to the company.

Quality Management – Quality Control

In creating quality control it is important to choose what to control, establish a unit of measurement, establish performance standards, measure performance, interpret the difference between actual versus the standard, take action on the difference. This is similar to Dr. Deming’s Plan-Do-check-Act cycle.http://technacon.com/category/dr-w-edward-deming

Quality Management – Quality Improvement

Improvement is created on a project by project basis. The first step is to identify specific projects, organize teams, discover causes, develop remedies, prove the effectiveness of the remedies, deal with cultural resistance, and establish controls to the hold the gains.

Quality Management – Return on Investment

As a rough rule of thumb, the average improvement project is worth $100,000 per year in decrease waste/cost while the average one-time cost is approximately $10,000-20,000.

Quality Management – Lessons learned

Some of the lessons learn through applying quality improvement projects are:

  • The return on investment in quality improvement is among the highest available to managers and quality improvement is not capital intensive.
  • The most decisive factor in the race for quality leadership is the rate of quality improvement

 

http://www.qualitycoach.net/products/jurans-quality-handbook-the-complete-guide-to-performance-excellence-9780071629737.asp

Quality Management follows the same basic principles as financial management, has a high return on investment and a low capital investment requirement.

Responsibilities

Quality is cyclical. Everyone contributes to the responsibilities

Quality is cyclical. Everyone contributes to the responsibilities

Who is Responsible for Quality?

Just who is responsible for quality; the customer or the processor or the supplier? Dr. Juran said they were all responsible for quality.

Customer Responsibilities

The customer must share in the responsibilities to produce a product that is fit for use. They must:

  • Transmit the needs to the supplier
  • Provide feedback to the supplier
  • Obtain feedback from the supplier

Transmitting the need is fairly clear. Provide accurate information as to specifications, delivery and expected costs. Providing feedback to the supplier is also easy to understand, if the product is unsatisfactory, tell them.

It is also necessary to provide positive feedback. At one company a customer service rep always did a little more for her clients. She would follow up on orders and check on their progress, not just in the MRP system but going out to the factory and making periodic physical checks. Thanks to her efforts more than a few errors were prevented. However, her supervisor had a performance measurement of time taking calls. When the rep was in the factory she wasn’t taking calls. There was no feedback system to her supervisor as to the effectiveness and importance of her actions so it did not appear on her performance reviews. Ultimately the rep was terminated.

The last bullet is one that is normally left out. Some of this comes from the concept “the customer is always right” or as one person put it “he who has the gold rules. The customer has the gold.” We supplied a product to an automotive manufacturer. The specification for the nut placement on the bolt was “8 mm max from the end”. Product shipped to specification. The first shift had been trained to slip on the product over both parts and tighten the nut. This was only possible if the nut had been backed off to the end of the bolt. The second shift slipped the product on one side and later inserted the other side. With the bolt backed off, the product would fall off before the assembly could be completed. Both shifts rejected the parts continually for the nut placement. The customer was furious over our “poor quality” back charging us and threatening to pull the business. They were not interested in hearing the cause of the problem. We were ordered to “fix it!” The fix – we sent our sales staff in once a month on both shifts to train the operators. The issue belonged to the customer they needed a mechanism to receive feedback.

Processor Responsibilities

The people and equipment producing the product are the most common owners of quality. They must:

  • Plan the process to meet the customer needs
  • Control the process to meet the customer needs
  • Improve the process based on customer feedback

This is the focus of most corrective actions and many people end up with the misconception that the processors own the quality responsibilities. This is not true. Quality is everyone’s job.

In my example of the customer service rep being fired for proactively checking in the factory, how many people caught the fact that she was addressing a symptom of poor quality and not the root cause? Since she was finding repeated mistakes in the process which would have produced poor quality parts, she should have gone to the person in charge and pointed out the situation. That should have resulted in root cause analysis and corrective action and she would not have needed to be in the factory.

Supplier Responsibilities

The supplier is the company as a whole that takes and order and provides a good or service. The supplier is also the previous step in the process. It is imperative that the supplier:

  • Knows who are the customers
  • Understands the needs of the customers
  • Avoid creating problems for the customers
  • Obtains feedback from the customers

As a company it is not enough to understand your own product and offer a “take it or leave it” attitude. The world is competitive and someone else is willing to step in and understand the customer’s needs and deliver exactly what they need, when they need it. A supplier must understand how the product is being used and proactively offer goods or services that best fit the customer needs. In the example of the nut position, we did offer to make two part numbers with the only difference being the nut location. The down side was maintaining inventories so the ultimate solution was for our staff to train the customer’s operators. Once we went in and talked to the people using the parts we were able to come up with a solution that avoided a problem for the customer. Did the customer fail to take on the responsibility to train their operators? Yes. Did we step up and solve the customer problem? Yes.

In the case of the internal customer, it is important to know how our product/subassembly/service is used. At one plant, a subassembly was a piece of cord cut to a set length and dropped into a gaylord then shipped across the ocean. At the next step the operator would attach the cord to a hook and wind the cord up, securing it with a rubber-band. As you can imagine the cords were twisted and tangled together and difficult to separate, wasting a great deal of time and frustrating the operator. The ultimate solution was to buy the cord in spools and set up a machine to attach the cord, measure and cut to length and automatically wind it. As an interim step the people cutting the cord would wind and rubber-band it with a tail sticking out to have the hook attached. The time to do the next operation was cut to a fraction of the original time. An interesting by-product was the wound cords took up less space and decreased the shipping cost as well.

Quality is everyone’s responsibility. It is the customer’s responsibility, the processor’s responsibility and the supplier’s responsibility. When each takes their responsibilities and acts on it the overall cost goes down and the quality improves.

5 Ways to Assure to the Success of a Quality Improvement Process

 

Assuring the success of a Quality Improvement process

Mr. Philip Crosby did a lot of work with various companies and he came up with the following 5 points from his experience. While my experience is not as world-renowned as his, it has demonstrated the accuracy of these points.

Make Sure  Management’s Commitment to Quality Improvement is Genuine and Evident

 This is the #1 reason a quality improvement process fails. If management is saying the words but does not mean them, employees will know and will only give a cursor level of investment in the quality improvement process. If a middle manager is trying to do this knowing their management is not on board, they will have very limited, short-term success.

Keep the Quality Improvement Process Serious, but Fun

This is people’s livelihoods on the line. Do this wrong and jobs are going away, most likely yours will be one of the first to go. Select serious issues but be willing to let team members be spontaneous and open. Sometimes the only way to create that spark in a quality improvement process is with a little humor.

Make Sure Everything in the Quality Improvement Process is Positive and Handled with Respect.

The team must be equal. This means no one person’s opinion is more valued than the other team members and no one’s opinion is less valuable than the other team members. There is a reason people are on the quality improvement process team. Have a non-judgmental way to capture ideas and evaluate them.

Make Sure All Managers Are Involved in the Quality Improvement Process,

Understand the Concepts and Steps of the Quality Improvement Process, and Are Able to Effectively Communicate Them with Subordinates.

Hold a discussion with the managers about the quality improvement process. Encourage them to speak about their concerns and then address those concerns. It takes only one manager saying all the right things but quietly placing roadblocks to the process to bring the quality improvement process to a grinding halt. Watch for the team member that has not had the time to complete an assignment and consider what action needs to be taken with their manager. That should include identifying a non-supportive manager and turning that problem over to the next level up.

Adapt the Quality Improvement Process to the Company and/or Location’s Personality

This is a process and depending on the company culture it can take many forms. If everyone has a 4 year degree and works in a paperless system, the process will be much different than for a company where the majority of employees cannot read or write in any language and communications is through pictures and colored tags. One is not better than the other. The quality Improvement process must fit the culture.

14 Steps to Establish Process Improvement

This article is presented as part of an overview of the quality guru’s of the 1980’s. The 14 steps were develop by Mr. Philip Crosby and presented by Philip Crosby Associates. Reading “Quality Is Free”, “Quality Without Tears”, and “Quality Without Pain” are helpful in understanding how Mr. Crosby developed his philosophy and encouraged others to use it. For more information about Philip Crosby Associates, go to http://www.philipcrosby.com/pca/index.html.

Quality Councils guide the quality Improvement Process

Step 1 of the 14 Steps – Management Commitment for Process Improvement

Management must make clear where it stands on quality. Without top management commitment the process is doomed to failure (see “Four Ways a Quality Improvement Process Can Fail” and “Five Ways to Assure the Success of a Quality Improvement Process”).Top management must communicate it has a zero defect strategy if it wants a quality improvment process. The primary action to accomplish this is to write and communicate a Quality Policy. In ISO 9001 all documentation comes from the philosophy in the quality policy. This is the reason why that is so important.

Step 2 of the 14 Steps – Quality Improvement Team to Create Process Improvement

A framework is needed to coordinate the quality improvement process which is driven by the quality improvement team. This is the vehicle to remove roadblocks to progress and provides a formal communications medium to ensure the quality improvement efforts are coordinated throughout the company. Each department should have a representative on the team and a charter is needed. The team members take responsibility for one or more of the 14 steps. This team is not the problem solving team but manages the various activities associated with quality improvement throughout the company.

Step 3 of the 14 Steps – Measurement of Process Improvement

One definition of insanity is doing the same thing repeatedly and expecting a different result. Measurement is the determination of the result. Teams measure the difference their changes have made. Measurement is done in simple terms of things (part XYZ) or events (shutdowns or recalls) and compared to past performance to see if it is a process improvement, no change or a deterioration.

Step 4 of the 14 Steps – Cost of Quality and Process Improvement

The Cost of Quality takes “things” and “events” and converts them to a common language – money. The group charged with making the change does not monetize their efforts this is done at a central level providing for consistency of costing. (see “The Cost of Quality”) Speaking in terms of money allows managment to justify the costs to create process improvement.

Step 5 of the 14 Steps – Quality Awareness as it Relates to Process Improvement

The purpose of Quality Awareness is to raise the personal concern felt by all employees toward the conformance of the product or service and the quality reputation of the company.[1] As Dr. Deming also said in his 14 points, we are all dependent on each other. Process improvment can not occur unless the entire team agrees it is needed.

Step 6 of the 14 Steps – Corrective Action for Process Improvement

Corrective Action Systems respond to 3 sets of rules – Input rules, Administrative rules, and output rules. Corrective action looks for systematic rather than anecdotal solutions. The process should have steps and be formalized throughout a company. They should be designed to eliminate compromising on conformance to requirements. Implement “Do It Right the First Time” to create process improvement.

Step 7 and 9 of 14 Steps – Zero Defects Planning and Zero Defects Day impact on Process Improvement

Zero Defects day is designed to be an event to create a personal experience for all employees so they know a permanent change, a process improvement, has been made. Management is committed and this is a process not a project. It will not go away.

Step 8 of 14 Steps – Employee Education Creates Process Improvement

All employees must understand the Absolutes of Quality so they can competently carry out their role in the quality improvement process. This means an education plan as well as reference documentation such as procedures and work instructions. Treat Suppliers as if they were employees when it comes to education.

Step 10 of 14 Steps – Goal Setting for Process Improvement

Total quality is achieved incrementally over time but in order to keep focused on process improvement it is important to establish realistic goals. Employees must participate in the goal setting and have a say in what can be accomplished in a defined timeframe.

Step 11 of 14 Steps – Error Cause Removal in Process Improvement

Employees have to be able to communicate roadblocks to accomplishing quality improvement process. Communication must flow in both directions; management must make expectations clear and employees must define issues and concerns that they believe will prevent them from being successful. The process to do so should be simple and formal with procedures  and assigned responsibilities to address employee concerns.

Step 12 of 14 Steps – Recognition of Process Improvement Efforts

Everyone needs to know their hard work was recognized. A quality improvement process must include a formal program to recognize both individuals and groups for their actions which create quality improvement.

Step 13 of 14 Steps – Quality Councils for Process Improvement

The purpose of this step is to bring together the appropriate people to share information that may benefit other areas of the company. In a large company with multiple divisions it could be a periodic meeting of the quality managers. They must also audit the quality improvement process for effectiveness and be will to go to management if the system is not functioning as planned.

Step 14 of 14 Steps – Do It All Over Again for Continuous Process Improvement

A quality improvement process never ends. It must be a permanent management responsibility. The focus must be to always satisfy the customer. At this time the Quality Improvement team changes although at least one member of the old team must stay on to provide information and continuity in the quality improvment process.

 

 



[1] “Quality Improvement Process Management College Manual” @1987 pg 4-6-1 “Purpose”

Do It Right The First Time – DIRTFT

DITRTFT or “Dirt foot” generally brought giggles but it served the purpose of grabbing people’s attention. The anachronism stood for “Do It Right the First Time”. The statement seems almost ludicrous in today’s business environment, but is it?

DIRTFT means Do It Right the First Time where "It" is the customer requirements.

What is the “It” in Do It Right the First Time?

“It” quite simply is the customer requirements. However, simple is not so simple. The customer requirements must be clearly defined and communicated. This is done with drawings and specifications but also must be considered when developing procedures and training programs, performing Failure Mode and Effect Analysis, and reviewing process capabilities.

At one plant where I worked, the customers were getting consistently non-conforming material. They were furious and they had a right to be. The problem had been going on for more than a year. The problem was not that the employees were making non-conforming product, or the tooling had not been maintained of the process capabilities were poor. The problem came when a dimension was transferred from a customer drawing to a working drawing and was reversed. As soon as we corrected the drawings, modified the tooling to manufacture to the drawings and gave the information to the operator to check the product, we went from 100% non-conformance to 100% conformance to requirements. Not following Do It Right the First Time can be caused anywhere in the process, not just at the operator level.

The Attitude of Do It Right the First Time

Have you ever had an employee say something along the lines of “Hey, I just do what I’m told and keep my head down and my mouth shut.” Do It Right the First Time does not even enter this picture. Creating an atmosphere where employees feel free to speak up when they see a problem or have a question is the first step in creating an atmosphere that supports “Do It Right the First Time.” In today’s economy with high unemployment, management must work overtime to make sure the negative attitude does not invade their facility. What are you doing to make sure your company employees have an attitude to “Do It Right the First Time”?

Four Ways a Quality Improvement Process Can Fail

 

Is your Quality Improvement Process destined for success or failure?

While reading through the binder I received in 1987 from the Philip Crosby Quality College in Winter Park, FL I came across a section titled ‘Four Ways a Quality Improvement Process Can Fail’. I was expecting something that quality professionals had created fail-safes to prevent. What I found instead was four conditions  that are just as valid today as they were in 1987.

Failure #1 – Lack of Management Attention to the Quality Improvement Process

That’s it. Either management is on-board with a Quality Improvement Process or they are not. It is the reason the Management Review is so critical to the success of ISO 9001 companies. If management is involved in providing resources and determining which projects have what priority than the company is on the right road for a successful Quality Improvement Process.

Failure #2 –  Allowing the Quality Improvement Process to Become a Motivational Program

When the Quality Improvement Process goes from creating real and lasting preventive measures and becomes a method to “get the employees involve” or create “caring” in the employees it will fail. Employees will see through the rhetoric and realize management is not serious or interested. The expectation is the employees will change in some way rather than the system.

Failure #3 -Focusing the Quality Improvement Process Only on Operations

Operations makes the widgets that get sold but the cause of non-conformances can occur in order entry, purchasing, engineering, logistics – any area of the company. That is why ISO 9001 is a quality management system. The whole system must be controlled to be effective. The entire process must be looked at, not just the area where they manufacture a saleable product.

Failure #4 – Allowing the Quality Improvement Process to Become A Problem-Solving Committee

There is a saying, “When you are up to your ears in alligators, it is difficult to remember your original objective was to drain the swamp.” Solving problems is critically important but the problems won’t go away until a systematic review of the entire process occurs. Corrective measures are different from preventive measures.

Thank you to Mr. Crosby for this tool to analyze the Quality Improvement Process. It is just as valid in 2012 as it was 1987.