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Auditing Urban LegendsUrban Legends are the stories we hear often as true, yet are false. In this section we will explore the internal auditing urban legends, and reveal the truth. In some cases, the legend may, in fact, be true. Other times it may turn out to be a false-hood. Most of the legends we will explore will not be in auditing, per se, but rather in the QMS. Many internal auditors fall victim to urban legends, and write nonconformances based on legend rather than fact. One thing to remember, if your QMS, your registrar, or your customer requires something...then you still have to do it! Legend or not. As always...Good Auditing! Got a legend, you wish to share, submit it!
Legend 1: All jobs require work instructions. Truth:
Most jobs will need some type of work instructions. If nothing more than how many parts to run (or how long to perform the task), and what work is considered acceptable (specification). A router, or Control Plan may very well meet this requirement. A surgeon needs to know what surgery is being performed, on whom. A grounds keeper needs to know where the limits of the yard is that he/she is mowing. How detailed the work instructions have to be will be answered next. In some cases, step by step instructions on how to perform a task may be necessary. Legend 2: Truth: Imagine a hospital registered to ISO 9002:1994. You are scheduled for a heart valve replacement. Would you want work instructions so clear that the hospital can take someone from the street to perform your operation. I don't think so. The same thing goes for all parts of manufacturing. Painting, welding, any skilled trades, or any other task that requires practiced skills cannot be performed with a work instruction alone! Manufacturing is not alone, retail, service, healthcare, even governmental positions can fall into the same problems. If you had a detailed work instruction, do you think you could paint like one of the old masters? If that were true, there would be no experts. Your level of detail should be appropriate to the job, and who you expect to carry out the job. Legend 3: ISO won't let us post our work instructions on the wall. Truth: No place in ISO 9001 (or 9002) does it prohibit posting work instructions. The requirement in Element 4.5.2 a) reads: "the pertinent issues of appropriate documents are available at all locations where the operations essential to the effective functioning of the quality systems are performed;". If a job affects quality, and there is an appropriate document that needs to be there, then the organization must make sure the pertinent issue is there. If the document meets all the requirements of your document control system, the standard doesn't care if it is posted on the wall, chiseled in the floor, or etched on the machine [although the latter would create some difficulty should the rev level change]. Legend 4: Our internal auditors must be certified, or at least must have attended a formal internal auditing class. Truth: This one is true. In fact, the standard requires all internal auditor training to be through internal-auditor.com. Okay, okay...I lied. The requirement is that you have "trained personnel" [4.1.2.2]. Element 4.18 Training, allows you to qualify individuals based on experience, training and education. Although it would be a good thing to have formally trained internal auditors, on-the-job training would be acceptable provided they can demonstrate competence. Legend 5: ISO requires a process map and flow chart of all our processes. Truth: ISO 9001:2000 does require you to identify the processes and show their interrelationship. This can be accomplished through a number of methods. Process mapping is one method, but it is not the only method. A narrative explanation could also be effective. Mapping, or flowcharting may be the easiest and most common, but they are not required.
Legend 6: ISO requires a master list. Truth: In the 1994 version of ISO (and QS), the requirement was a "a master list or equivalent". In ISO 9001:2000 and the second edition of ISO/TS 16949, the words "master list" do not even appear. Master lists are just one way to ensure the correct version of documents are being used.
Legend 7: ISO requires an approved vendor list. Truth: ISO/QS/TS requires you to evaluate and select your vendors. There has never been a requirement for an approved vendor list. It is probably a good idea, but it is not required. Do not mistake this for the customer approved (mandated) vendor list. They are two entirely different things.
Legend 8: All gages must be calibrated. Truth: It is not the type of gauge that determines whether calibration is required, but how the gauge is used. If it is used in a manner that requires calibration, then it must be calibrated.
Legend 9: All forms must be controlled. Truth: Depending on what the form is, and how it is used, it may or may not have to be controlled. And local control of forms is permitted under ISO 9K.
Legend 10: All vendors must be surveyed Truth: You must select and evaluate your vendors. Surveying them is not required.
Legend 11: All customers must be surveyed Truth: ISO 9K2K goes much farther than the 1994 version, but there is no requirement for surveys. ISO does not want to dictate "how" to determine customer satisfaction. Nor do they want to prescribe the method of collecting data. That part is up to you. the requirement is to monitor information relating to customer perception. Surveys are one method, but not the only one.
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www.CWMS.org www.SearchManufacturing.com www.REC-Communications.comAll rights reserved Ruth Ellen Carey Communications 2000-2004
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