Iso 14000 9000


Published on

Iso 14000 9000

Published in: Business
  • Be the first to comment

  • Be the first to like this

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

Iso 14000 9000

  1. 1. Iso 14000 9000One of the most daunting aspects of an ISO 9000 project is the documentation. Manymanagers stay awake nights with visions of ream upon ream of bureaucratic paperwork.Often, people are forced to re-visit old fears from high school English class, where theirpapers were not well received. While it is possible that these fears will be realized, it isnot really necessary. There are several techniques that can make the process of creating adocumented quality system easier, more effective and less intimidating.These techniques range from simply using the appropriate tools, and applying theappropriate structure, to using the right personnel. As always, proper planning, clearlydefining responsibilities, and controlling the process are imperative in its success. Thereare five areas that must be addressed in order to develop a quality system with the leastheadaches. These are process definition, structure, tools, format/grammar and flexibility.Process DefinitionMany pundits will tell you that each person at the company must write their ownprocedures in order for them to be effective and appropriate. They argue that no oneknows the process better than the person who performs it every day and that if they arenot the ones to document it, they will have no ownership. While this argument has somemerit, it only works well if everyone at your company is a capable writer with a properword processor and has the time and inclination to write procedures.The reality is probably that much of the staff, even those at management level, arentcapable writers and dont have access to or sufficient practice on word processors.Involving many people in the construction of a set of documentation will yield differentstyles, levels of detail, formats, etc. creating considerable problems for the personresponsible for pulling it all together. This person has probably already investedconsiderable time and effort in the training and support of people who will likely neverwrite another document for the organization. In addition, few people have the time todevote to procedure writing. Because of this, everyones involvement is a goal that isunachievable at most organizations.Who then, should write the procedures? The company should designate a person who isresponsible for the generation of procedures. That person should decide format andstructure for the procedures and will do most, if not all of the writing. Designating asingle person assures that the procedures are written in a timely manner without excusesand without people shirking their responsibilities. It also enables the company to assign acapable writer with the appropriate skills to determine the processes involved, identifythe right level of detail, and document them in such a way as to avoid the "ownership"issue. Finally, having a single person write the procedures ensures that there is aconsistent format and structure. This is one area where considerable benefit can be
  2. 2. achieved with the use of an outside consultant. This frees up internal resources to focuson the key purposes of the business and ensures an expert job.The remaining problem is how to write the procedures. The person writing the proceduresmust ensure that the process is accurately depicted. This is typically done by interviewingthe staff in the area for which the procedure is being written. The interview is used togather needed information about the process and to determine how compliant the processis. It also allows the staff to have input into the procedure, so they dont feel "out of theloop" and can feel "ownership" of the documents once created. From the informationgathered in the interviews, the writer writes the procedure, reviews and edits it with thestaff.StructureBefore writing the documentation, it is important to determine the structure. It is a verycommon mistake to get the structure wrong and usually occurs in two ways. The first ishaving too many, too few or improperly structured levels of documentation. The secondis structuring the documentation around the standard as opposed to the business.A proper ISO 9000 quality system is written in three levels. Level one consists of theQuality Policies. This usually takes the form of a Quality Manual. Level two consists ofthe standard operating procedures. Level three refers to the work instructions, checklists,forms, and other task specific documentation. This is the structure which has provensuccessful the world over and is alluded to in ISO 100013. Some consider that records arethe fourth level, but this is not the case. Records are evidence of facts and history; theyare not documents that are maintained up to date. Once a form is filled and filed away itis not pulled out a year later because the format of the form has changed. The format ofthe form is a level three document but once filled in, it becomes a record. Yes, records arepart of the "documentation" of the system but it is a mistake to assign them a level andassigning them a level serves to confuse the important difference between and procedureand a record.There is often some confusion about what a quality manual is. Often, the company willbundle its entire quality system including procedures and forms into one manual and callit the Quality Manual. Although this is one possible definition, it does not help anorganized structure. A Quality Manual is a document that describes the policies forquality, defines the structure of the quality system and defines the structure of theorganization and responsibilities for employees. It does not include detail of operationsand should avoid the specifics of procedures.A typical Quality Manual would include several sections. First, it would define thestructure of the organization. It might do this by including and organizational chart andby defining the responsibilities of key personnel. It would also describe the structure ofthe documentation used in the quality system. Finally it would reiterate each requirementof the standards and state briefly how they will be addressed. In many cases, simple
  3. 3. acknowledging the requirement and stating that they will be met is enough. Again, theQuality Manual is not the place to describe specific procedures.This brings us to level two. Level two refers to the procedures. These describe how thecompany operates on a department by department basis. Procedures typically do notinclude detailed task specific, or order specific instructions but focus on the managementlevel information. How is the department organized? What information is received? Whathappens with that information? What tasks are performed? What reviews take place? Andwhere does information go or get filed?When writing procedures, it is important to structure them around your business, notaround the standard. Too many organizations take the easy route by generating oneprocedure for each element of the standard. If you dont have a product identification andtraceability department, then you shouldnt have a product identification and traceabilityprocedure. This requirement of the standard should be included in your other procedureswhere it applies. Consequently it is clear that when procedures have been structuredaround the standard, the system has been designed to gain compliance, not to add value tothe way the company is organized and managed.Level three refers to the detail oriented, lower level documentation. This might includechecklists, blank forms, task instructions, blueprints, drawings or order specificdocumentation. It does not include completed forms or other records.ToolsDocumenting an entire system is a sizable task. Before embarking on such a task, it ishelpful to gather the appropriate tools. First, this means a current word processor. Havinga modern computer and word processor will pay for itself in cost savings and avoidedfrustration. The modern word processor includes automated spell checking, grammarchecking, and many formatting features.Before diving into procedure writing, it is important to know how to use these features onyour word processor. Before starting, experiment until you are comfortable using theword processors features. By doing this, you will be able to incorporate these featuresinto your first documents, rather than having to incorporate them later.A variety of software tools are available to help generate and manage ISO 9000documentation and systems. Generation software suffers the danger of leaving you with aboiler plate system, twenty procedures and focussing on compliance. Managementsoftware can be useful as the sophistication of the requirement increases. Managing largenumbers of instruments internally might warrant calibration control software, forinstance. However, considerable sophistication already exists in current word processors,spreadsheets and databases that come with your computer. These tools are oftenexpensive, sometimes complicated and do not always yield the promise.Format/Grammar
  4. 4. When writing procedures, theres no need to be Ernest Hemmingway. Writing proceduresdoes not require creativity or a huge vocabulary. In fact, all of these things can hurt theprocess more than help it. The best procedures are simple, clear and concise. All youneed to remember is to avoid passive voice and avoid excessive wordiness.Passive voice makes procedures difficult to read, and should be avoided when possible.For example:The Packing List will be signed by the Receiver and entered into the system. (passivevoice)The Receiver will sign the Packing List and enter it into the system. (active voice)As you can see, the passive voice sentence is less clear and is longer.Excessive wordiness or the use of complex words also makes procedures difficult to read.It is important to keep procedures simple and appropriate for their audience.The Receiver will be cognizant of any discrepancy in the materials prior to signing thePacking List. (difficult to understand)The Receiver will note any damage or defect in the materials before signing the PackingList. (easier to understand)FlexibilityAnother common mistake when creating documentation is to create rigid procedures thatare difficult to follow and maintain. Procedures should be written in a manner that theyare flexible and dont paint you into a corner. Also, they should avoid hard references,complex numbering schemes and other unnecessary bureaucracy.Several hard references are shown below:If a nonconformance is found, the employee will document it according to SOP 4.14. rev5If a nonconformance is found, the employee will document it according to SOP 4.14If a nonconformance is found, the employee will document it according to section 5.5 ofthis procedure.All of these references pose problems. The first one references a procedure by numberand references a revision. That means that every time the referenced procedure isupdated, this procedure would have to change also. This is difficult to maintain and likelyto be forgotten. The second one references the procedure by number only. This eliminates
  5. 5. the revision problem, but is still subject to number changes. It is also difficult for thereader to follow. The third one may seem simple enough, but it may still pose a problem.If a section was added to the procedure before section 5.5, then the number would changeand the reference would be wrong.A more appropriate method follows:If a nonconformance is found, the employee will document it according to the CorrectiveAction Procedures.This is clear to the reader and is unlikely to require changes.Many companies number their procedures. This practice is not necessarily a problem. Itdoes, however, have the potential for problems. The most common problem is the use ofISO 9000 section numbers ("SOP 4.5 - Document Control", "SOP 4.18 - Training"). Thismay deem logical, but there may be instances where there are several differentprocedures that address a single ISO clause. There may also be instances where a singleprocedure addresses several ISO clauses. How would these be numbered? In addition, theyear 2000 revision of the ISO 9000 standard does away with the 4.X numbering system.This will make 4.X numbering systems obsolete. If your document numbering system iscumbersome, eliminate it. ISO doesnt require document numbering.Finally, it is important to write procedures in a flexible manner so that they dont restrictyour employees unnecessarily. In short, dont make a rule unless its necessary.The employee will retrieve the document and will stamp it in the upper left corner with ared "obsolete" stamp.The employee will retrieve the document and will clearly mark it as obsolete.The first statement would mean that you would have to train all of your employees tostamp in red in the upper left corner. You would also have to ensure that the employeeshave access to red ink and a stamp. Even after taking these steps, it is likely that theprocedure often isnt followed. The second statement provides the same protection, butdoes not restrict the manner in which the employee complies. It is just easier to follow.ConclusionISO 9000 documentation is an involved task - it has to be! Done properly it will addvalue to your business. Before embarking on your own documentation investigate thesituation thoroughly and ensure you have expertise in the subject and time and resourcesto see the project through. It will save you a lot of time and effort.Finally, do not make the mistake of starting with the work instruction documentation.This is the most common and wasteful mistake of ISO 9000 projects. ISO 9000 does not
  6. 6. call for any level three, work instruction documentation, unless it is necessary - and if itsnecessary, it already exists. This type of documentation may add value by better definingprocesses or enhancing training, but you are not doing it for ISO 9000 compliance. Makesure you want it.If you want to download over free 50 ebook for iso 9001 standard, you can visit:http://iso9001ebooks.infoBest regards