DOCUMENTATION: CERTIFICATION

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During one of my document checks I asked an  accredited calibration agency for a copy of a calibration certificate be­cause I knew the ‘certificate’ on file was simply a Work Order issued by the technician who had checked the equip­ment, and which only referenced the certificate number. I wanted the correct certificate to be on… Read more »

QMS: STAFF TRAINING

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Too often employees believe that the quality system is ‘man­agement business’ and they are shocked when they find out that everyone is involved. We do not want to wait until assessment to put this right. I have found it helpful to include training so that staff: know where to find the Quality Policy Manual know… Read more »

QMS: BASIC CARE AND ATTENTION

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  Amid all the glamour of design, new processes, new technology, measurement and “lean management”,  the less glamorous elements of a quality system might not be given the priority and attention they deserve. For example, housekeeping is very important. The assessor will be looking at the general cleanliness and care which is evident (or not)… Read more »

QMS: MANAGEMENT REVIEW AGENDA

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Management Reviews of the quality system (quality management) should be scheduled as rigorously as Material Review Boards or other corporate reviews. Agenda items are assigned to the appropriate levels of authority. The QUALIDOC MANAGEMENT REVIEW AGENDA is as follows: A.  Quality Management Representative (QMR) report – status of quality system: results from quality system audits… Read more »

YOUR QUALITY SYSTEM: IS THE LANTERN LIT?

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  I am the first to say that I know next to nothing about statistics. I barely scraped through the mandatory course at university which an unfeeling administration required that I take to complete my studies. My interest and spirits heightened considerably when I realised that the course was more about recognising spurious statistics rather… Read more »

QMS DOCUMENTATION AGAIN: THE READER

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“I am so clever that sometimes I don’t understand a single word of what I am saying.” ― Oscar Wilde, The Happy Prince and Other Stories I hope I never give that impression with my writing. I sometimes edit my writing to the extent that I come full circle, back to where I started (well, almost). Unfortunately,… Read more »

QMS DOCUMENTATION: BANE OR BLESSING?

Posted by & filed under AS9100, ISO9001:2015.

One of my first jobs on a contract is to review documents currently in use in the quality system.  Documentation is often the weakest link in the quality system chain and can be a major nonconformance in the certification audit. In my experience the assessors could regard the following as non-conformances: no central record (Master… Read more »

LEANING TO LEAN MANAGEMENT?

Posted by & filed under AS9100, ISO9001:2015.

LEANING TOWARDS LEAN MANAGEMENT?   Lean enthusiasts often overlook the difference between perspective and performance. In their zeal to control the traffic (remove bottlenecks) they don’t recognise the imperative connections between traffic point duty (on site observations according to procedures) and control room perspective (overall strategy and implementation). Lean management allows little margin for error… Read more »

QUALITY: LIKE BEAUTY, IS IN THE EYE OF THE BEHOLDER

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QUALITY, LIKE BEAUTY, IS IN THE EYE OF THE BEHOLDER Many years ago I visited a small company which was the sole-source subcontractor for a critical military winter item. As I chatted with them about their business, I asked how they recorded their nonconformances. The Managing Director waved towards a couple of sad-looking photographs of… Read more »

ISO9001 and service organisations

Posted by & filed under ISO9001:2015.

  Service industries often have a  tough time apply­ing the ISO standard to their activities. The Nonconforming product control requirement is an example . I have applied the Qualidoc procedure successfully for telephone service distributors, voice and data communication for a large pharmaceutical company and a research laboratory, I have also worked with many marine… Read more »