PCB007 Magazine

PCB007-Nov2020

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98 PCB007 MAGAZINE I NOVEMBER 2020 Procedures and work instructions need to be user-friendly, clear, concise, and as brief as possible while remaining functional. The mag- ic—and difficulty—is to make the complex into the simple. This requires a particular skill set and a vast knowledge of quality systems and customer expectations. As Steve Jobs famously said, "That has been one of my mantras: focus and simplicity. Simple can be harder than com- plex. You have to work hard to get your think- ing clean to make it simple." Documentation Hierarchy Employing the KISS Principle to the docu- ment naming and numbering system will be- come an invaluable asset and continue to pay ongoing dividends with each and every audit and customer visit. The way to structure the system is a continuous hierarchy that flows down from the top-level procedures. Whatever the hierarchy structure is called, they typically have the levels identified (Figure 1). Naming Convention If the system is going to be based on ISO or AS9100, I strongly recommend the numbering to follow in some way the requirements of the standard. Prior to the 2015 and 2016 respective revisions of the standards, this would be prob- lematic, as each new revision would require a renumbering/naming of the entire QMS, and disconnecting from the standard was advis- able. While ISO 13485 was late to the harmo- nization party, the next revision should align with the others. That being said, aligning with the standard simplifies internal comprehension and corre- lation with external auditors compared to ran- dom sequential numbering. With the harmoni- zation of the 2015/2016 revisions, we are told the numbering and naming of requirements will remain the same (harmonization) through future revisions. Changes in requirements will simply fall into one of the current "buckets," if you will, so renumbering will thankfully be a thing of the past. In other words, requirement 9.3 will always be management review going forward, etc. The key to an effective documentation sys- tem is to employ an intelligent numbering con- vention. One very effective approach to apply- ing the KISS Principle to the documentation hi- erarchy is to tie each procedure or work instruc- tion numerically to all forms and attachments used in the execution of each. I have a passion for simplification and take the same approach with document control. For example, continuing with management review, the QMS procedure could be "P-920 Management Review." The "P" stands for "procedure," the "920" stands for requirement 9.2, and "management review" is the name of the requirement. This would be the name and number of the procedure and the name of the electronic document file. It's simple and easy to correlate to the standard. The next KISS Principle would be to assign an intelligent number to associate every form and attachment used in the appropriate QMS procedure. Continuing with the management Figure 1: Documentation hierarchy levels.

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