Archive for the ‘Identification and traceability’ Category

Well, I guess many of you quality professionals are looking at the highly publicised failures within this particular business sector with your head in your hands, totally at a loss to explain how such serious issues can ever have been created.

As we know 9001 offers the basic framework by which to control business processes but above that you have far more onerous systems such and medical, aerospace, automotive and, of course, food.  How can such basic requirements as sourcing and identifying beef fail to the point that horse meat is allowed to enter the food chain.  Now OK the testing required may be expensive but there must be a possibility that a sampling process would suffice.  Mind, with all the testing that is now being carried on I wonder what the quality costs are running at now?

The supply should be controlled by the approved supplier list process backed by clearly defined purchase orders and adequate inspection on receipt.  The fact that all this seems so basic might suggest to some that a deliberate policy of ignoring the agreed procedures can be the only explanation.  One can understand some may be nervous of conducting a root cause analysis with that hanging over them as it may clearly be a complex situation. Looking at this article below it also appears that the recriminations are starting to fly. Just click the picture to open the full article.

Food scare

Whether there is another agenda involved here or not, make sure you quality principles remain intact where ever you work.  More advise as to how to achieve that at the ISO 9001 Support Centre.

I often get asked this as sites get close to bringing in the auditor so I put together this summary of what I would expect to see in relation to the five main paragraphs so it is possible for anyone to gauge if they are ready.

How much of the system?
The QMS should have been operational for at least 4 – 6 months with quality records created in every section of the system.  A full set of controlled procedures, work instructions and forms should be in use backed by an effective record retention system.  Evidence of controlled issue of such documents either electronically or as hard copy needs to be visible.

Clearly at least one Management Review meeting needs to have been undertaken with minutes on file and adequate resources in place – especially the Management Representative! An effective Quality Policy and objectives should in place and understood by staff.  The scope needs to be adequately declared with a note of exceptions from Section 7 and the company should be able to demonstrate an effective means of communication to the staff, perhaps a newsletter, notice board items or briefing sessions.

A full set of training records need to be on file for employees plus a means to determine training needs and requirements e.g. a skills matrix. The relevant aspects of infrastructure and environment would be addressed as appropriate and a current Organisational chart visible for all to see how they fit into the structure.

Where it really counts
Operational procedures should be complied with in Sales, Purchasing, Design, Calibration and Production and control of identification and status evident throughout the company. You need to be adhering to your Approved Suppliers and Subcontractors List with adequate inspection from Goods Inwards, In process through to Despatch.  Customer property needs effective control if relevant along with preservation of product in stock, in process and on despatch.

All internal audits have to be completed in accordance with your schedule by a qualified auditor and corrective action reports documented and action in a timely manner. Evidence of Quality Objectives and their measurement is required so as to demonstrate continuous improvement and you must have effective control and analysis of non-conforming product.  Finally, clear evidence of customer satisfaction data collection and evaluation should be present.

Help is at hand
After all that if the Management Representative wants some moral support then he can subscribe to the free 9001 Training Guides. You can find a full set of samples on Utube on the QualityAuthority channel or click on this link to go to the web site to take up the free subscription for the full series of ISO 9001 Training Guides.

I have been well pleased with how positive the feedback has been for this series of  Training Guides.  In addition it has been fascinating to hear of the diverse reasons people have had for subscribing in the first place.   With several groups now running the next stage is to make some sample vids available on Utube so people can get a feel for what they are about and how they might assist them in their role as Management Representative.

Uploaded so far are snippets on Common Mistakes with Correctives Action, Approved Suppliers List and the one below on Identification and Traceability.  Excerpts from Non-conforming Product, the Quality Policy and Quality Objectives will follow shortly.

You can take out a free subscription for this free series of ISO 9001 Training Guides by clicking this link.