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"Your System Is Perfectly Designed…


System pic courtesy AR130405 pixabay

For the results you’re getting.” Remember that old proverb? If your system’s results need an upgrade, then so does your system, its individual parts, or the way they fit together.


QMS documentation usually starts out as a set of procedures and work instructions: some bare-bones and trusting in worker competence, and some more complex to cover contingencies. Either way, a few months or a few years later, the documentation most likely needs to catch up with the way you’re actually working now. And every auditor can tell you, when one procedure or work instruction changes, it almost always affects other procedures. So it may be that, if you have been getting more complaints, returns or internal catches of rejects, something isn’t fitting together anymore.


How do we find out what isn’t working? A pizza-lunch committee will bring out complaints and some ideas, but a series of strong process-based internal audits (yes, we are recommending internal audits again) is the most thorough time-tested method to find the facts.


Audits are not just “what is your process for this function, and how do you follow it?” but asking “how do you actually do this? Always the same way? What happens when ____ is missing? What is the result? What do you do with the output? Who gets it next?” The best way we’ve found to do those audits is for the auditor to include the line lead or supervisor in his audit team; those can observe whether the current actions fit the plan (the written procedure or instruction), and then ask their own questions or offer observations once the auditor has worked through the planned questions.


Analyzing data is an important part of improvement, revealing information on an overview of the system. The data you’re looking for is process performance for each function, for instance:

  • time to first article

  • amount or percent of scrap by process or by shift

  • percent of NCP

  • measuring expected time vs. actual time to completion

  • time and materials spent on correcting or replacing defective parts

  • time spent clarifying unclear prints or specifications

  • time spent clarifying unclear traveler/router information

  • number of information disconnects, mis-connects and missing data

  • number of hand-written notes on work instructions

  • machine downtime due to tool breakage, unplanned maintenance, or program errors

And the list goes on and on.


Good data and internal audit interviews can show where and when issues are, then you can analyze whether re-writing a procedure, for instance, is necessary for clarity. If lack of understanding the specifications or process is the case, is better training a factor? Is the cure something as simple as new reading glasses?


Optimal results come from a well-tuned, optimal system, which takes an investment in time and effort. But over and over, we at PQA have seen astonishing results from companies that look carefully at their systems and make well-planned improvements. Is your company in need of internal auditor training, to help you look for those improvements? That’s one of the services we offer, and it could make a big difference. Contact us today and we’ll give you a quote for training!

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