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blogs - quality systems
Below are the blogs of managing consultant John Mason. Please enjoy, comment, challenge.
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Procedures -v- Work Instructions
To the 'lay' person there is no difference. To the partially informed it is a convenient differentiation in an attempt de-value a document when found by an auditor. To the truly expert, any document that has been generated to describe a process, no matter the detail, the prescription, the intent, should be judged by the end-user and subsequently reviewed for accessibility, relevancy and most importantly impact on the total system. But enough pontificating.
whole books, white papers, conference key notes have been generated on what the heck is a preventive action. Now before we go on, let's answer this question first. What is the difference between preventive and preventative. The short answer is none. The short definition of preventive (according to http://www.yourdictionary.com/) is 'anything that prevents'. And when you search on preventative it says 'variant of preventive.' And so in the real world they are just variant of each other with the focus on prevention. So what is the relationship with corrective action? The standard gives each one whole sub element. The majority of non-quality-expert people simply merge the two with the intent of having one precede the other in a continuous improvement cycle. I think this is good thing. But it cannot be an exclusive use of the preventive sub element.
In the real world there doesn't have to be a difference, so long as both people discussing them have the same intent. In fact, the standard doesn't just talk about forms, it talks about documents in general. Well, that is whole blog on its own. But in the quality world, both forms and records are very different and need to managed very differently.
Entire books have been written about calibration of test equipment. In ISO 9001 it is called; 7.6 - control of monitoring and measuring devices. In many cases the control of such devices is critical to both product specification and contract specification. In some cases if you don't control such devices carefully and within risk parameters the only way to verify a product is meeting contractual requirements is to conduct destructive testing. This is not a good protocol or commercial outcome since you cannot sell a product (or service) that has been destroyed in a test to prove it working properly. But on the flip side, let's not test or calibrate every little piece of equipment in the business just to be on the safe side. The cost alone of such outsourced services could send you broke or at least dent your gross margins. Be smart about what you 'need' to calibrate, what you need to monitor and what is just a good guideline to know.
the quality manual
an extract from the standard itself concerning 'the quality manual' is;
4.2.2 Quality manual
The organisation has established and will maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.
here a two definitions; 1) wise, expedient, or prudent conduct or management; 2) a principle, plan, or course of action, as pursued by a government, organization, individual. my definition is; a rule for or intention of a group in a particular function. not a vision or mission. mission, vision, value statements, etc are very important documents and are not the subject of this post. in iso 9001, the quality policy requirements are that top management ensures the quality policy; a) is appropriate to the purpose of the organisation, b) includes a commitment to comply with requirements and
Do you have to develop process maps for ISO 9001?
In 4.1 of the standard, there are a number of elements that an organisation must do including identify processes, determine the sequence and interaction of processes, determine criteria and methods of control, ensure resource availability and monitor, measure and take action. Nowhere does the standard then imply that an organisation should then go out and produce flow diagrams, process flows, charts or maps to describe their business. Although each of these tools are very useful, if they are not part of your culture or documentation, think hard at including them into your management system.
What is an external document?
quality.com.au's definition of an external document is; Any document, irrespective of format, that your company does NOT have control of the content but it is used / referenced in your management system. Such documents include; standards, legislation, statutes, supplier marketing collateral, etc.
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