One of my first jobs on a contract is to review documents currently in use which could be included in quality records. A common issue is naming documents with insufficient clarity, aka category errors. On one contract I discovered what was supposed to be a Design Change Notice (DCN): was headed ‘Change Notice’. I knew what an important document this usually is for ensuring that design changes are passed on to the assigned design authority ESPECIALLY WITH THE ADVENT OF AS9116 NOTICE OF CHANGE.
In my experience the assessors regard the following as two non-conformances:
- they perceive that someone is ignoring the quality system (e.g., not everyone is committed to the system and it is not under control)
- uncontrolled documents (no central record, poorly numbered or otherwise identified, poorly located, no check on issue or revision status (Master Document List, Document Index).
The assessors may overlook one or two isolated instances where forms are not signed or procedures are not followed, but if they find more than one or two they might regard this as a trend. Non-conforming trends mean that the assessors will stay on your premises much longer while they dig around for more evidence. If they find trends, then they will issue a major non-conformance which has to be corrected before you can be recommended for certification. Who wants to drag through all that again? Better to get it right the first time.
Working instructions are a critical part of quality records and DOCUMENT CONTROL. They will be examined by the assessor for their availability to the employee at point of use and their current application to the job. Many employees are very experienced and do not need to refer to working instructions, but they should be in place for new employees and refresher training. Working instructions can range from procedures in text, large posters, small handbooks with pictures (e.g., what constitutes a nonconforming item or condition) to computer and video programmes. Don’t forget to take into account the environment in which the instruction will be used. A hi-tech office is going to be very different from a machine shop. Laminated posters are very useful for dirty environments. They also help with easy removal of graffiti!
Working instructions and all other quality records must be ‘legible to the product’. This means that pencil may not be used for records or any other instrument that would result in ambiguity. I remember on one contract that the Quality Manager assured me that all old (obsolete) files were safely stored away from documents currently in use. When I checked, I found they certainly were, but in cages in a dockside warehouse that was under attack by seagulls most of the time. Most of the files were in tatty boxes covered in bird plop and so were certainly not ‘legible to the product’. It took weeks to clean up the mess.
A good QAM will ensure that working instructions and procedures are available at point of use, are legible, in current revision status and accurately reflect what is needed to do the job. Having them in the right place at the right time will not do any good if they can’t be read because they’ve been eaten by rats or covered in flood water or dust. Paper records are still an important part of many business environments and should not be neglected in the haste to automate documents via technology.