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.

 

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”

Point 4 – End Lowest Tender Contracts

End the practice of awarding business solely on the basis of price tag. Instead require meaningful measures of quality along with price. Reduce the number of suppliers for the same item by eliminating those that do not qualify with statistical and other evidence of quality. The aim is to minimize total cost, not merely initial cost, by minimizing variation. This may be achieved by moving toward a single supplier for any one item, on a long term relationship of loyalty and trust. Purchasing managers have a new job, and must learn it.

Dr. W Edward Deming

We all do it. We go to a grocery store and will but the item that costs a few pennies less. Our perception is “they’re all the same”, but are they?

A very long time ago, before generics dominated the market, a major pharmaceutical manufacturer hired me as an engineer. Generics dominated conversations. Should they be allowed to replace brand name products? A well respected television news program did a segment on the subject. They stood in front of our plant, held up a generic pill and made the statement the pill was the same as anything made in our plant, the only difference was our pill cost a dollar and the generic cost a dime. What they didn’t know, or didn’t say, was our pills held the effective ingredient content to plus or minus 1% while the generic held the effective ingredient to plus or minus 25%. Generics took over the market and now if you want a name brand product, the doctor must write the prescription as “no substitutes” and some pharmacies will try very hard to get the patient to allow them to substitute. They insist, generics are exactly the same as name brands, they just cost less.

We look at suppliers the same way. They have to be the lowest price item coming through the door or we won’t buy. The companies that do research and could give us the next breakthrough product are competing with off-shore elements that copy the researching facilities products in violation of patent and copyright laws. And we support the theft by purchasing the cheapest initial product.

A bolt manufacturer can produce excellent product that never needs sorting or inspection. It goes direct to the lines and never causes a problem. A new supplier comes in a fraction of a cent cheaper in initial cost and we jump on the deal. Of course every tenth bolt has damaged threads and can’t be used but we buy from them and pat the purchasing agent on the back for our great savings.

How do we turn this around?

Look at your suppliers. When you go to evaluate the cost, look who helped you solve a problem with an innovative idea. Put a dollar figure to the increased sales or saved customer sales. Adjust the purchase price to reflect what the supplier did for you. Go talk to the line workers and look at the supplier costs on the cost of quality report. Adjust the supplier price accordingly. Point out to all the companies making an effort to quote how this information impacted your purchasing decision. Word will get around. Your suppliers will be watching what they do and looking to help you build your business and how can you beat that?

Point 3 – Cease Dependency on Mass Inspection

Eliminate the need for mass inspection as the way of life to achieve quality by building quality into the product in the first place. Require statistical evidence of built in quality in both manufacturing and purchasing functions.

Dr. W. Edward Deming

When ISO 9000 first came out, the auto manufacturers turned their noses up at it because it did not call for statistical process control. After significant discussion QS 9000 arrived to save the day. It should have been called ISO 9000 plus. The standard listed the ISO 9000 requirement and then added what the automotive companies had learned from Dr. Deming. Things stayed that way until 2000 when the ISO 9001 standard underwent major revisions to focus on continuous improvement and promote statistics.

Converting an inspection based workforce to statistical savvy operators isn’t as hard as it seems. It takes common sense. Process control limits are as simple as deciding when to mow the lawn and how much to adjust the blades or how high a temperature to set a stove when cooking up dinner. If you can compare them to everyday things that don’t use numbers, even the most math-a-phobic operator will lose the fear and begin to apply the technique, but that leads to point #8 and this is point #3.

Have you ever converted a process from inspection to statistical process control? How did it go? I did, it was a fun experience and I’d do it again.

Point 2 – The New Philosophy

The new philosophy

Adopt the new philosophy. We are in a new economic age, created in Japan. We can no longer live with commonly accepted levels of delays, mistakes, defective materials, and defective workmanship. Transformation of Western management style is necessary to halt the continued decline of business and industry.

Dr. W. Edward Deming

He spoke those words over 30 years ago but how much more true are they to today. Industry is going away from the USA in search of cheap labor, but has it been worth it?

What does management need to do differently to bring manufacturing back? What do we need do do differently with our children so they respect the person working in the factory? What do we need to do differently so people want to work for a company and have pride in what they do?

ISO started out as a European response to the superior quality of Japan and the USA. How do we bring business back on shore? What do we need to create an environment where manufacturing next door to your client is a wise business decision?

We start by looking at the real overall cost instead of chasing the short term profit. Moving off shore to reduce labor cost can be a false economy. Compare not just the labor and overhead savings but:

1. Increased shipping costs, especially expedited costs

2. Loss of control, does the new facility really understand your clients’ expectations? Assume makes an Ass out of U and Me, what is acceptable in one culture is anathema in another. Lead paint is unacceptable in the USA but used on childrens toys in third world countries.

3. Longer lead times. I dare you to get a rush shipment during Chinese New Year for the far east.

4. Putting a competitor in business. I worked with a fortune 100 company on a project. At the time they experienced extreme frustration. They had sent a product to a Chinese company for manufacturing quotation. The next thing they heard came not from the supplier but their customers. The quoting company had gone to their customers and under cut the fortune 100 company’s prices with an identical product, right down to the UL certification number. Everyone agreed it was a sad situation and the fortune 100 company had no recourse.

5. Addressing a dissatisfied customer. How much is in the pipeline when your customer notifies you of a problem? Add in the real cost of creating a gatekeeper while a solution is worked out and clearly communicated.

Point 1 – Constancy of Purpose

Constancy of purpose

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.

Dr. W. Edward Deming

How do you create constancy of purpose in an economic time like this? Companies are struggling to stay in business and there are two places to put every dollar of resources so what do you do?

First you figure out how to keep the clients you have. That means understanding what makes you different from your competitors and building on that difference.

Second you understand what they like and dislike about your service and your product. You meet with your employees to discuss how to improve on the dislikes and support the likes. Making them part of the solution.

When your employees feel they are part of the solution morale improves and you drive out the fear of job loss and build loyalty.

You hold a steady course. If you started out with the right idea, don’t second guess yourself. There are ups and downs to everything, including the economy. Companies that chase fads are always one step behind the competition. Instead you get a long term picture, derive goals to meet that picture and work as a team with your employees to accomplish the end goal. Ultimately you will come through tough times stronger than the competition.

Think of it as you would your retirement investments. You buy in and hold through the lows in the market if you are in for the long term with a good investment strategy ultimately you will have a stronger financial position than selling at every market dip.

ISO 9000 is a Change to a Healthy Life Style, Not a Crash Diet

ISO 9000 is a change in the way everyone in the company thinks and behaves. It is not easy to implement correctly and it is very easy to back slide into the old way of doing things.

Think of ISO as a corporate change to healthy living from a junk-food junky. Ninety-nine percent of people don’t get up off the couch dust off the potato chip crumbs and start running five miles while munching on tofu.

Most people get on the scale and come to the realization they have to make a change. They may start out with a crash diet or they may add a walk to their daily routine, the diet may make a big impact in the short term with disastrous long term results while starting a reasonable exercise program will create gradual improvement your need for long term good health.

The corporate scale is the Cost of Quality report. It measures where there is waste and what it costs to keep control of problems. This is a report you should craft carefully because it is how management is going to measure your success or failure. Understand where the numbers come from, what it takes to collect them, and just how closely it relates to the P&L report. If you can’t find a close correspondence between the two reports, you need to revise the Cost of Quality report.

You need to break management into the idea that you are looking at a 5-10 year plan. Yes there will be measurable improvements in the short term but the real benefit comes from continuously monitoring and improving. You are about to implement Dr. Deming’s, Plan-Do-Check-Act and you better do it right or don’t bother doing anything at all.

Don’t Skip the Good Stuff Part 6

Management Responsibility

            There is a saying, “What goes around, comes around” or you can look at this circle and considerate it the visual definition of “synergy”. There is a reason this is a circle. Management responsibility, resource management, product realization, measurement, analysis and improvement are interrelated. Take away any one of these and the ball, better known as your company profits, drops dead. It is another way of looking at Dr. Deming’s ‘Plan Do Check Act” model.

 

            Looking at section .2 the top box in the circle is management responsibility. I have seen many corporate executives abdicate this point to the quality manager. Usually they pass along the responsibility but not the authority. So what is management responsible for doing?

  1. Steer the bus

This means providing a long term plan, as in a 10 year objective and nothing as vague as “make money”.

  1. Provide the fuel

Management must find the people, funds, equipment and raw materials to make the process work.

            If a company is going to grow and remain in business there must be a written policy for doing business and goals to be achieved. Unless a company is a charity the basic is to make a profit. The question is how much profit? A company isn’t going to double in size without planning, or if it does, it won’t stay that way for long. Management must set out a clear and definitive game plan to get long term positive results.

            The fuel is something else management must provide. Imagine making medicine with untrained people. The result would be catastrophic. Management must find the right people and provide training. Good people are hard to find, they should not be treated as a commodity or the long term growth will suffer.

            Equipment is another resource management is responsible to provide. This does not mean going out and ordering a one of a kind machine to make your particular widget. It does mean making sure the machine consistently produces acceptable product. There is a tool called total productivity maintenance. I have seen examples where using team work and asking the operators for input has resulted in a machine which is 10 years old increasing in productivity by 30% and reducing variation by 50%. Normally productivity goes down and variation increases as a machine ages.

            Raw materials are another matter. There is an old saying, you can’t make a silk purse out of a sow’s ear. Raw materials must be capable of turning into good product. At one point I worked for a pharmaceutical company. We produced an injectable drug. The basic material was organic so there were variations. However on one particular lot an extraneous peak showed up in the gas chromatograph analysis. Checking backwards, that same peak had been in the raw material. Countless man hours were wasted because the raw material was not capable. Management had approve the purchase because they were desperate to fill a stock out situation and didn’t want to acknowledge the material was bad.

            Having provided everything necessary to make the product it is time to do just that – produce something to sell. There is an element of QS 9000 I like to implement in ISO 9000 applications. It is called the Pre-Production Approval Process (PPAP). It tests the ability to make a consistent product over a reasonable duration of time, usually half a shift.

            Once the product has been produced, it is time to measure and analyze for improvement and send it to the customer for feedback. One of my clients made toothpaste closures. They made millions of them and were very proud that they only had 12 open closures per 100,000 manufactured. The cost to the toothpaste company was huge down time. Every open closure shut the line down for cleaning for 10 minutes they were filling at the rate of 600 tubes per minute. Seven people stopped producing salable product and wielded scrub brushes for every open cap. With this feedback, my client designed a machine to make sure the closures snapped shut and removed those that did not. Cavity marking on the rejects gave the root cause of the problem and before too long they were whistling along at 3.4 parts per million open caps. Without the analysis and the customer feedback, my client would have lost a very important piece of business. Which would have impacted the long term plan.

So there you have it. The really good stuff for ISO 9000 is before you even get to the standard.

Don’t Skip the Good Stuff Part 5

            What is continual improvement of the quality management system? It is the big picture. It is looking at the performance of all the sub-processes that make the whole process, from getting the customer specifications and orders, to making sure the parts arrives on-time, at a reasonable cost and in a useable form.

            Here is where the quality manager has to avoid the biggest pitfall known to the engineering mind – trying to pick the fly poop out of the pepper. Engineers don’t know when to stop, and they are right, continuous improvement never stops but you have to know when to move on. I can say this as I am an engineer and there have been times when my engineering tendencies have driven my husband, a really knowledgeable construction consultant, to offer specific guidance (Honey, hand me the darned 2 x 4, it doesn’t matter that it’s off by a thirty-second).

            It is the Quality manager’s responsibility to evaluate the effectiveness of each step in the process and to determine where to improve the process. This means having a way to measure the performance of each step and a method to compare the various results. There are a number of tools to use.

            A good customer satisfaction survey is one. One of the most common things I see is a four or five generic question survey where any rating less than excellent draws attention like road kill draws flies. Sales staff and customers a like groan at the thought of filling the thing out and the input has no value. Do some research into your customer base. Talk to your sales staff, field engineers and repair people. They interacts with the customer in the field and you need their input on what is an effective line of questions to get real information from your customer.

            Complaints and returns are another resource when it comes to measuring customer dissatisfaction. There is a difference between measuring satisfaction and dissatisfaction. Depending on the price of a part, you may never know the customer has a problem. They may throw it away and go elsewhere without ever talking to you.

            Measuring internal costs to achieve customer satisfaction is a third. If you have to 100% sort parts before shipping them, this might be a process that needs to improve.

            Once you have all this data you must convert it into dollars of impact on the company. It is the only way to make a fair evaluation. How much is it taking away from profitability? How much sales have we lost? How much sales could we increase? Put a rough estimate together as to costs to evaluate a solution for each problem. Now you have a report that management can understand. Now you are ready to truly implement ISO 9000.

Don’t Skip the Good Stuff Part 4

            Let’s jump to the next page and Figure 1, don’t worry, we’re not skipping the good stuff, just getting a visual. We need to talk about how to obtain results of a process performance and effectiveness.

            We have to start with the customer requirements. Not just the in-house print but the specifications, prints and input of the customer. We need to know how they are using our product and what the method of installation is.

            The example of the reversed angle explains how the transfer of information from one document form to another can be a problem, but we also need to understand how the customer is installing the product.

            I remember being called to an automotive company to explain our excessive defect rate on a part. both shifts were reporting huge problems. The threats were long and loud. Until I pointed out that the two different shifts were installing the part in very different ways. In one case the nut had to be run almost completely down. In the other it needed to be so close to the tip of the bolt as to be in danger of falling off. Our specification from the customer was to have the nut run on “no less than 8 mm”. Of the 100 “defective” parts they had tossed on the table all 100 were at 8 mm. We than helped them do a study to find out which method of installation was most effective for their process. We left the retraining of the shifts to them.

            We could have left the customer embarrassed at their actions and gone away slapping ourselves on the back and talking about how smart we were. However, the problem was not solved and would have come back sooner or later. We would have ended up with a reputation as a poor quality supplier even though we were not at fault.

            Many times the customer’s requirements are not what they have written down. It is very possible the customer doesn’t even know what they require. When you are sure you are meeting the communicated customer requirements and they are having problems with your parts it is time to go find out how the parts are being used.

            This is the two bars in the figure labeled customers “requirements” and “satisfaction”. The circle directly relates to the standard. The continual improvement bar is for next time.