Discussion board

We added a new section to this website, as a request of several users of it. In this section, we shall insert questions asked by visitors, along with our answers. Just follow the links below. Some of visitors preferred to be anonymous; therefore we shall keep their privacy. If you would like to post a question to us, follow this link.

Anonymous

Adelina

Tiberiu Popa

Question: We are a small manufacturing company of 55 employees and we set up a quality system and we consider that is sufficiently implemented. What's the maximum number of nonconformances so that to pass the certification?

Answer: Dear Sirs. Unfortunately, you have a wrong vision regarding certification process. It's because, many of certification bodies blindly apply rules set by them, rules spread around to inspire fear and force to some kind of bribe.

We agree to one rule of these certification bodies. If there is found just one major nonconformance, certification should be declined. As for minor nonconformances, rules like 5 or 8 minor nonconformances will imply the decline of certification just doesn't work, in our opinion. The reason is simple. Let's take for example two companies, one with 1,000 employees and the other one with 5 employees. Upon assessment, each of them gets 9 minor nonconformances. According to mentioned rules, each of them should not pass the certification. In fact, things are not so simple.

For the bigger company, it's very possible that those 9 nonconformances to be spread throughout entire organization (one at purchasing, one as delivery, one at IT, etc.). There is absolutely no reason of concern that the system does not work properly. All these nonconformances could be treated as incidents, not as systematical failures of the system. This company must pass the certification, no doubt about that.

The smaller company case may lead to idea that implementation of the system is not very good. There are only 5 employees and 9 nonconformances. Statistically speaking, it's almost two nonconformances per person. If the nonconformances are relatively equally spread to personnel, certification should be declined. If they are concentrated to one or two persons, it still might be a problem of implementation, and, as a possible consequence, the decline of certification.

Above example should not be applied literally. This means that a good certification body will analyze the impact of each nonconformance over the system, and finally, over the customer satisfaction. It's not the number of nonconformances who counts, it's their importance. Our advice is to try finding a certification body which guides itself under mentioned principle.

Question: How can I become a good quality consultant or auditor?

Answer: There is no magic solution to this question. Good consultants are few and their level of competence comes from many years of experience. This experience is not strictly related to ISO 9000 standard, but comes also from various "types of management". A good knowledge in human resource management, finance and accounting, technical field, applied statistics, marketing, investments, planning, communication, etc. is required also. Good consultants will never impose the organization a given certification body. They will just advice the organization what would be the best certification body, leaving the final decision to the company. Good consultants will never say that a system can be made in two weeks; they will explain to the company that a quality system is a very serious thing and needs time to be in place.

Most of quality consultants have as background education a simple training in ISO 9000 and, from time to time, collateral standards. Knowledge is one thing; knowledge combined with lot of experience is totally different. In order to become a good quality consultant, the best solution would be to work for some time with professional consultants.

A good auditor would follow the same basic scheme. Here, things are a little bit easier, due to requirements of IRCA or similar organizations. Stages in evolution of a quality auditor are pretty well defined by these organizations. One interesting thing is that auditors can hardly become consultants, because of their barriers raised by themselves, due to their previous activity. Their creativity is limited; their minds are constantly following the standard's requirements. Thus, they simply cannot propose an adequate solution, well adapted to organization's needs. The other way, consultant to auditor, is far easier. Mind flexibility, as a result of previous experience allows consultants to do very good audits...

One more thing about good auditors... They will always know where is the separation line between giving advices and recommending something during audits. It's surprisingly how many auditors don't know where to stop doing recommendations... A real example of stupidity we saw from an auditor who pretended to be a very good one: for a mass production company, she required that all workers to undertake a technical drawing training. The mission of those workers is to assemble the products, not to read and interpret technical drawings. For this activity there are available supervisors. Furthermore, those workers had the minimal knowledge of reading the drawings... And another example: an auditor required the organization to calibrate the tape measures and to get records for this action!!! All those tape measures were in good conditions, no deterioration of scales, no bending of tape, good locking and unlocking system, easy extraction of tape. Just note in these two examples that each auditor required the treatment of supposed nonconformances. They didn't recommend them! They required them! An excellent auditor in those two situations would simply raise the nonconformances and will let the auditee to decide on needed actions.

Question: How can I comply with clause 8.3 of the standard (ISO 9001:2000) for security servicing? How can we prove that we are controlling nonconforming products? What records? For 8.2.4 what records should we keep in this case, to maintain compliance with the standard?

Answer: Reading ISO 9001:2000 standard, the answer is straight: all of them. However, this subject deserves a deeper investigation.

Under the clause 8.3 Control of Nonconforming Product, organization is required to "maintain records regarding the nature of nonconformances related to product", which means, in other words, that authorized personnel has to write down on a paper (usually a form), details about the depicted problem. The standard doesn't say how detailed should be the description, nor where on how to be written. It just demands to record it.

But when a nonconformance occurs? As a general rule, wherever and whenever a deviation from a stated rule appears, there is a nonconformance. The first set of rules of utmost importance is those described in your documented quality management system. Other rules are described in legislation, technical specifications, etc. It's easy to observe that in theory, there are plenty of opportunities for nonconformances. Thus, would be no surprising at all to see tons of nonconformance reports; this depends on how well is operating your system. Please remember that the requirement for recording the nonconformance is referring only to product or service you are making or providing.

What happens for a mass production manufacturer, where the quantity of nonconforming product is in relation with that huge production? Obviously, the standard doesn't excuse you to write it down. Here, a very simplified and easy to use recording system has to be in place. A sneaking method would be to record on a single paper details about a group of nonconforming products, which have the same description, as long as the standard doesn't clearly require writing a paper for every single nonconforming product. Please note applying this method is a two way street: it may help you, also it may cheat you.

Last remark is in relation with clause 8.5.2 Corrective Action of ISO 9001:2000, also 8.5.3 Preventive Action. These clauses require you to investigate the causes of nonconformances, and then, to decide whether corrective or preventive actions are needed. Before moving further into discussion, let's remind the definition of corrective and preventive action. A corrective action is that measure that has to eliminate the cause of an existing (found) problem. A preventive action follows the similar line, under the observation that the measure will be against a potential nonconformance (a problem that may occur in the future).

So, there are plenty of nonconformance reports, where is recorded the nature of nonconformance. Authorized personnel have to investigate the cause of nonconformance. The standard doesn't tell you how to conduct the investigations. Our advice would be to apply the Analyze of Multiple Causes, so that to identify the primary cause of the problem. Another possible method would be the use of Fishbone Diagram. Once you determined the cause of the problem, authorized personnel have to determine if there is any need for corrective action. Here comes the big hit. Companies that operate a quality management system "just for fun", simply says, most of the time, that there is no need for corrective action. Most valuable companies will see in every nonconformance a source of improvement, simply by investigating every problem in detail, then by identifying and implementing corrective actions.

For a mass production manufacturer, investigation of every single nonconformance and determination of related corrective action may require a massive number of personnel, which might be costly. A solution we propose to simplify the use and still keeping the improvement process at an acceptable level is to establish some limits for acceptability for the number of nonconformances, grouped by specific causes. This method doesn't absolve you of the responsibility to record the nonconformances. It just helps you to do the following: as long as the number of nonconformances is below the limit, no corrective action would be needed. If the number of nonconformances goes beyond the limit, that will require a detailed investigation, along with determination of some corrective actions and implementation of them. There may be needed the use of statistical techniques in order to determine the acceptable level of nonconformances.

We said previously that writing a nonconformance for a group of products with a similar problem may cheat you. The reason for that is: in some cases, different causes may lead to the same problem. Therefore, it's for sure that you will miss the investigation of real causes. Let's have an example for a car manufacturer. The nonconformance report may look like: three cars did not start. How you will investigate the cause(s)? As a group, you can't. For each car, a separate investigation should be made. As an example, the first car does not start because of a faulty electronic device, which may be cause by a poor reception process, which may be because of a lack of very clear and detailed inspection testing. The second car does not start because of inversed wires, as a result of lack of training of worker. The third one does not start because there was no fuel in the tank, as a result of negligence of the worker. In conclusion, for a single given problem, recorded in a group, several causes were determined. In above example, all of identified causes should be addressed by adequate corrective actions, such as preparation of detailed inspection procedures, reviewing of training plan and supplying of adequate training.

An excellent quality management system should go beyond requirements of 8.3. The requirement should be extended beyond the term "product". In other words, wherever a deviation from specified rule is determined, it should be treated as a "nonconforming product". As an example, if the documented system says that no purchasing order is sent to supplier without prior approval of Senior Purchasing Manager, any purchase order which will not comply with this rule is a nonconformance. The cause of such nonconformance must be investigated, along with establishing of need for corrective action.

As a final conclusion: winning companies sees an opportunity for improvement in every single nonconformance. Surviving companies will stick mostly to direct ISO 9001:2000 requirements, focusing on the product only. Loosing companies simply accept that for most nonconformances, no corrective action is needed...