Analyze of non-conformances

ISO 9001:2000 standard requires that all non-conformances which appear within processes to be investigated (section 8.2.3 of standard - no specific requirement for recoding this kind of problems, which in our opinion is not normal). However, if you don't record them, it's hard to believe that you are aware of them. Another requirement of ISO 9001:2000 comes from clause 8.3, where is specifically stated that you must keep records for non-conforming product. Obviously, there are no perfect processes, nor perfect products. This means that every company which operates a quality management system will have reports regarding the non-conformances found during operation of processes, also for non-conforming product. These reports represent one of the most valuable gold mine for improving the system.

In our opinion, most of the time, there should be two levels of analyze of these reports:

• one is the individual analyze, meaning that each reports has to be solved as satisfactory as possible;
• the other one represents the statistical analyze of reports, to depict trends and hidden causes, which couldn’t be seen initially.

An example of a chart in non-conformance analyze is presented to the right. The chart was drawn from data collected over a four months time interval, and was splitted baysed on main causes. The basic idea from this chart is that most of causes are incidental, meaning that a strong conficende in the system does exist. The system is working properly. However, thre are two reasons of concern, one of them indicating that a systematic failure in time still exist (red circle). Constantly, that cause appear, implying the appear of a non-conformance (not strictly the same one!). The second reason of concern is because of that cause with high values of occurence; howver, that cause is shown in two consecutive months, in the middle of time interval. Therefore a better conclusion can be drawn if the analyze is extended over a larger time interval.

Another example of work result from analyze of non-conformances is shown on the left. This time, was analyzed the performance of each working shift, in terms of rejects. Work shif number II has the poorest performance compared to other; further investigation is needed. For that particular example, the main issue was the unbalanced distribution of good and bad employees through work shifts.

Also, a valuable way of interpreting the results from analyse of non-conformance is to take in consideration other types of records, such as reports from internal or external audits, other evaluations carried out within organization.

Russell Romania (ISO 9000 Consulting) is able to offer you services in analyze of non-conformances. You will get not just simple reports with tons of graphs in them, but also we shall advice you on what are the bad and good things, also what would be the best solutions to improve processes and products.