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Title: Assessing ISO 9000 for Your Business : Key Elements and Strategies Author: Tom Taormina Publisher: Government Institutes Notes: ISO 9000 has become the defacto quality standard in over 140 countries. It's popularity is due to its elegantly simple tenets that will help any company with their strategic quality improvement efforts. This book is written in lay language to help you make an informed decision if ISO 9000 is right for your organization and how to implement it in most any environment
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You can order this book from internal-auditor.com at: http://www.internal-auditor.com/books.htm |
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This Month's Feature ArticleAuditing ResourcesLast month we looked at auditing management commitment. We also touched ever so briefly on the role resources play in showing management commitment. This month we will look at resource allocation in grater detail, and determine how we are going to audit the provision of resources. ISO 9001:2000 dedicates an entire clause to resource management. Evidently ISO believes that providing proper resources is that important. So do I. But how do we audit this clause? In order to effectively audit resource management, an internal auditor must first understand the requirements. ISO 9001:2000, Clause 6.1 breaks the required resources into two distinct groups; those pertaining to the Quality Management System (QMS) and those pertaining to customer requirements. The other requirements found in Clause 6 supports either group. When auditing the clause, the internal auditor must ascertain which group, if not both, is being referenced. Key questions in auditing 6.1 are to ask when are the resources determined, and how are they determined? Ask these questions for both the QMS as well as for determining and meeting customer requirements. Internal auditors often overlook the requirements for QMS resources and focus entirely on resources related to product. Let's take a closes look at what kinds of resources we are to audit and how to audit them. We will discuss them, as they appear in the standard:
Human Resources The requirements for human resources fall into two categories. The first states that "Personnel performing work affecting product quality shall be competent…". It is interesting to note that competency is only required for those whose work affects product quality. I often wonder about the rest of us! (just a joke) The two questions about this are; 'what is meant by competent?' and 'what proof would show necessary employees are competent?'. Competence is viewed as the ability to successfully complete a task. We gain competence through "…appropriate education, training, skills and experience.". We would show "proof" by two means. First, identify which of the above (or combination) we use to establish the basis for claiming competence. We can also show proof by the output of the process. If the person is consistently producing quality product, then there must be a certain level of competence. The second category of human relations requirements is training. The standard requires you to:
How do you determine the necessary competence? That by in large will be up to you. This can be accomplished through something formal, such as a Skills Management Program (SMP), or something very informal. Job descriptions, although not required, can also be used. Larger, more complex organizations will undoubtedly require a more formal process. Once you determine the competency you need, now you have to do something about it. You can train folks, providing them the education, and practice to gain competency, or you can just hire competent folks. Once again, there does not have to be anything specific. On-the-job training (OJT) is a good method of gaining experience, as is a formal apprenticeship program. The use of work instructions can also play a significant role in the level of complexity of the process. Evaluating the effectiveness of the action can also be quite simple. It does not require an annual performance appraisal, although that is one method of evaluation. Most managers automatically evaluate new hires and folks returning from training by observation. The question is; can the employee now do the job? A signoff is not required, but may be helpful. All employees whose job can affect product quality need to know where they fit into the big picture. How does my job impact the product and the business? They might not need to know all of the quality objectives, but they need to know their objectives. There are a lot of factors that impact what records are "appropriate". The size and complexity of the organization are two large factors. Remember that records are more than just training. Records also take into account education, skills and experience. This could include resumes and job applications. When auditing 6.2, keep in mind the organization. The majority of the evidence will be in the records. The organization should determine what records it feels are appropriate ahead of time. Their decision needs to be documented and should stand scrutiny. Infrastructure Infrastructure might be hard for most of us to audit. We don't really know what infrastructure is. Well, the standard tells us in 6.3. Infrastructure are those facility-related items that impact our product. This includes equipment and equipment maintenance. The question is not whether you have the latest and greatest equipment, but rather is the equipment, the building, the utilities and support services adequate to achieve conforming product. The key in auditing this is to ask if product is being adversely affected by infrastructure. Work Environment Related to infrastructure is the work environment. You must maintain the work environment appropriately so that it will not interfere with product conformity. Work environment can mean many things. The physical environment is obvious. But what about the emotional and social environment? Although the standard does not specify what environment, I would argue that this too can adversely affect product quality. Summary: Auditing resources might seem to be rather tough at first. But the better you know the requirements, the better you will be prepared to audit to them. There is nothing special here, and the rule you should apply is that if your resources are not causing problems, then they are probably adequate. In all cases, avoid placing your "things would be better if" thoughts into the auditing process. Most supervisors claim that if they had just two more people, or one additional machine, or more maintenance personnel, then they would have no problems. Employees state that if the room could be just a little cooler (or warmer), if they had a little better lighting, or better equipment, they could make more and better product. Neither of these are indications that there is insufficient resources. The evidence of adequate resources is conforming product going out the door. Our audits should confirm that. As always...Good Auditing! |
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Question and Answers: Q – How do we handle work instructions in today's diverse environment? A – First, what is the purpose of the work instruction? Secondly, what kind of work instruction are we talking about? Your work instructions must be clear enough so that anyone using them can understand them. This becomes a problem with shops that have multiple languages. A couple of suggestions. First, eliminate as many work instructions as possible. Most shops have far too many. Secondly, you can make the work instructions graphic in nature, and rely less on words. Also, you might want to consider training your employees in the local language. That would help in more than just work instructions |
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Observations from the Field When making out your internal audit schedule, it makes a lot of sense to first look the vacation schedule. This way you can make sure you do not schedule an audit during a key person's vacation. An alternative is to schedule the audit for a month, and allow the auditors and auditees to set a mutually agreeable time for the actual audit. But be careful not to schedule it so late in the month that you do not have any flexibility. |
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Element Understanding: ISO-9001:2000 Clause 8.5.1 Continual improvement "The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review" Each of the things mentioned here are tools that drive continual improvement. Through these, we find out where we are, where we are going and where we need to be. They work together and more than likely management review will be the item that binds them all together. But don't just stop with these. Add in other tools, such as Quality Function Deployment (QFD), Kiazen and six sigma. If the (your) goal is truly continual improvement, then any tool that achieves that end will be welcome. The ones listed above will be your indicators that your continual improvement philosophy will be on track. |
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Monthly Scenario Explained: May 2002's question You are auditing during 2nd shift and following the control plan. While interviewing the shift supervisor, you notice an obsolete procedure on the corner of his desk. When questioned, he states he keeps the procedure because he made some performance notes on it that is not connected to the procedure. He also states he is the only one to use them. The
answer: There are a couple of tough questions here. First, is there any possibility of anyone else using the procedure, especially on a different shift? Also, why did the supervisor take notes on a written procedure? Having an obsolete procedure around is dangerous. It might be possible, that in this case, the supervisor pulled the procedure out of the recycling bin for use a scrap paper, and that is okay…provided they are suitably identified as obsolete. Notes on the document probably does not qualify, although the supervisor only needed to hand write "obsolete on the document. |
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The Back Page:
Distractions In early February, Ruth Ellen was diagnosed with breast cancer, an event that permanently changes the lives of any family. Ours is no difference. The month was filled with tests, meetings and followed by more tests. The good news is that it has not spread. Ruth Ellen has cried more in the last month than all the time we have been married. As the husband, I have cried as well. The feeling of utter helplessness is almost overwhelming, reminiscent of when my toddler had a fever and wanted me to make it go away. There is nothing I can do. Actions can't help, and words are insufficient. The only thing I can do is to be there. Sometimes we feel the same way in the quality world. There is an event that we can neither control or influence. Others want us to "fix" things, but it is beyond our ability. The event starts impacting other areas (like getting the newsletter out late, yet there is little we can do. If we cannot change of influence the event, we must look at how the event changes or influences us. Others will watch us closely. For it is here, in the midst of a crisis, that our true selves show. Our actions telegraph our priorities and our heart. And others read or actions. It also influences how they react to the event. In this case, I've held off writing this newsletter for one week (Ruth Ellen's first week of chemo). In fact, it is in the wee hours of the morning, and Ruth Ellen is still asleep. Ruth Ellen knows that to me SHE is much more important than this newsletter, and now you know it as well. And I'm okay with that. I often say quality (and auditing) is my life (my license plate is ISO9K2K), but that is not totally true. God and my family come first. Always did and always will. Ruth Ellen's health may be a distraction, but sometimes distractions are okay. If you would, please pray for Ruth Ellen's health and recovery. While you are praying, also pray for this country. War is a very big and dangerous distraction! Dave ...Good auditing!
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Because this site uses information from many different sources, it must be pointed out that any advice, tips, information, etc., provided should be regarded as opinion and not fact! What works well for one company may be a disaster for another. Also, what one registrar, or auditor may allow, another may not. As always, reflect on what you read, see if it fits into your own quality system, and if it conflicts with your auditor...you've got to make a decision |
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