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in the field and are periodically reviewed, usually every five years to see if they should be maintained, updated, or withdrawn.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 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”.

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.

Don’t Skip the Good Stuff Part 3

            Staying in section 0.2, it talks about a process approach emphasizing the importance of

a)    Understanding and meeting requirements

b)    The need to consider processes in terms of added value

c)    Obtaining results of process performance and effectiveness

d)    Continual improvement of processes based on objective measurement

            Understanding and meeting requirements sounds so simple but it was the root cause of my old employer producing unacceptable parts (see Don’t Skip the Good Stuff Part 2).

            Considering the process in terms of added value brings to mind a mistake by a young process engineer. He was charged with finding a way to improve the quality on a product that had approximately two more years of production life and a total sales value of $100,000. He worked diligently researching new systems and methods. He was very proud as he stood before us and proposed we invest $2 million dollars to reduce a .1% defect rate on 250,000 parts worth about 40 cents each to a defect rate of .04%.

            The young man had found a solution that would improve our product quality but the value of his solution to the process was a negative. When working on process improvement it must be cost effective as well as quality effective.

            Look at how the goals are defined to a team assigned a process improvement task. Make sure the team understands the current costs and performance when they start.

            Obtaining the results of process performance and effectiveness and the continual improvement of processes based on objective evidence are blogs for another day.

Don’t Skip the Good Stuff Part 2

            If you skip down a couple of paragraphs (actually it is good reading so don’t skip the good stuff) it talks about the advantage of the process approach providing control over the linkage between the individual processes. This one may need to be read a couple of times to make any sense.

            Here is another way of looking at it. An auditor once told me 90% of his findings came not from the processes but from the hand off between processes. In other words, mistakes came from poor communications and lack of ownership. This is the place the quality manager needs to be most vigilant. No one else is going to be looking at these because no one has clear ownership. If you’ve ever spent even a few minutes on material from Dr. Deming or Dr. Juran you’ll understand how this creates failure. 

             I was doing an initial audit on a new client and following an order that was in manufacturing and due to ship the next week. There was a discrepancy between the purchase order revision of the print and the manufacturing documentation. In engineering I found the order had been returned to sales because the revision required a significant tooling investment on a product that engineering understood was being phased out. As far as Engineering knew Sales was handling the situation. As far as Sales knew, the product was in production. The problem was no system for communicating print issues back to the customer. Engineering wasn’t responsible and Sales wasn’t responsible so no one addressed the issue.

            Want to find the points in the system most likely to fail? Sketch the process from customer through your company and back to the customer. Circle points of hand off between departments. Check how this flows if things are working and how the flow of communication works when something goes wrong. Pay particular attention to who is responsible for what actions. Now quiz people and see if they are aware of their responsibilities.

Don’t Skip the Good Stuff – ISO 9001

Most clients I work with start reading the standard at section 1 “Scope”. This is a significant miss-step.  The really good stuff starts back at the beginning in the Introduction.

Pick up a copy of ISO 9000 and turn to section “0.1 General” (If you don’t have a copy go to http://www.asq.org/books-and-publications.html and buy it.) Now read the very first line, “The adoption of a quality management system should be a strategic decision of an organization.”  Think about this, implementing ISO 9000 should provide a long-term benefit to the organization. It is not just a plaque on the wall and a certificate to mail to customers it provides a strategic advantage by:

  1. Lowering costs
  2. Increasing sales

The rest of the section is interesting reading, but if you’re in a hurry, skip down to section “0.2 Process approach”. “This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.”

Here is the trick to making ISO 9000 effective, the process isn’t just the turning of raw material into widgets. It starts at the taking of the order and the understanding of the requirements and goes all the way to delivery at the customer.

Inside the big picture process are myriad sub processes which ultimately must be broken down and evaluated. However, the job of the quality manager is to make sure the big pictures sees continuous and on-going improvement. Too often ISO 9000 is pigeon-holed as a manufacturing process.

I had just started for a new company. Somehow I always seemed to get hired by the guys who were up the unsanitary tributary without a visible means of locomotion, and I was the paddle that had to save them. Anyway, a major customer called and in a loud voice and not so subtle terms informed me that our unacceptable product was on its way back, and we were going to be charge for the time their line stood down while they found a supplier to replace us.

I looked at the documentation; everything going out had met the prints and specifications. I pulled some parts off the shelf and checked them, also good product. Then I went back and compared the part print to the customer supplied design specification. Our part was being made with a 45 degree angle. The customer needed a 135 degree angle. Our parts were bass ackwards.  I worked with the tooling engineer and got both a short term and long term fix in place and called the customer. They grudgingly agreed to accept an overnight shipment of parts before calling the competition. Things worked out and we ended up one of their top quality suppliers. But the important thing to remember is the broken part of the system had nothing to do with the manufacturing process.

What is a process? Section 0.2 “Process Approach” states “An activity using resources, and managed in order to enable the transformation of inputs into outputs can be considered a process.”

The input to my old employer’s failed process was the customer specifications. The output was the manufacturing documents so my co-workers could build the widget. The activity was translating from customer language to in-house language. Don’t get caught up in thinking the process is just manufacturing. Most of the big savings I find for clients comes before I ever step on the manufacturing floor.