Nonconformational Effects

A nonconformity will only be classified as major in order to determine whether an audit should be terminated prematurely or de-certification effected. 

There is one technique widely used in the automotive industry for detecting and analyzing potential nonconformities Failure Modes and Effects Analysis (FMEA). There are Design FMEAs and Process FMEAs. The technique is the same - it is only the focus that is different. As clause 4.14 addresses potential nonconformities, the subject of FMEAs is treated in Part 2 Chapter 14. 

If you choose to accept a nonconforming item as is without rework, repair, etc., you are in effect granting a concession or waiving the requirement onI[/ for that particular item. If the requirements cannot be achieved at all, this is not a situation for a concession but a case for a change in requirement. If you know in advance of producing the product or service that it will not conform with the requirements, you can then request a deviation from the requirements. This is often referred to as a production permit. Concessions apply after the product has been produced, production permits apply before it has been produced and both are requests that should be made to the acceptance authority for the product. 

The standard requires the corrective action procedures to include the effective handling of reports of product nonconformities. 

This contains two separate requirements one for verifying that the prescribed action has been taken and the other for verifying that the action has been effective in eliminating the original nonconformity. The Corrective Action report should define the corrective action to be taken, the actionee, and the date by which it is to be completed. The action-ee should report when the action has been completed in order that it may be verified. The effectiveness of some actions can be verified at the same time but quite often the effectiveness can only be checked after a considerable lapse of time. Remember it took an analysis to detect the nonconformity therefore it may take further analysis to detect that the nonconformity has been eliminated. In such cases the report should indicate when the checks for effectiveness are to be carried out and provision made for indicating that the corrective action has or has not been effective. 

Several techniques have evolved to identify potential sources of failure in designs and process. These techniques serve to prevent nonconformity and hence are preventive action measures. One such technique is Failure Mode and Effects Analysis (FMEA). 

Audits should assess whether the actual quality improvement and safety activities comply with planned activities. The effectiveness of the overall quality and safety system should be scrutinized. Fundamental procedures and methods should be investigated to insure they are up-to-date and being followed in actual practice. The focus of the audit should be prevention, that is, finding areas needing improvement before they actually turn into situations that generate nonconformance. 

Does the organisation comply with the agreed requirements What problems and nonconformities have been revealed How can cost-effectiveness be optimised Are there any opportunities for improvement that can be realised Answers to these questions will be provided to the Chemical Leasing partners in a comprehensive report, which covers the certification process and documents not only results, but also opportunities for improvement, the keyword here being "Continuous Improvement Process". 

One important aspect of the quality systems approach is the ongoing collection and analysis of quality data to continuously evaluate quality system effectiveness. Historical data, process knowledge, and risk analysis methods can be applied to identify specific data requirements. Trending and other data analysis methods can allow identification of actual and potential sources of nonconformity so that appropriate corrective and preventive actions can be taken in accordance with established change control procedures. 

A corrective action is initiated to correct the cause of an identified nonconformity and to prevent it or similar problems from reoccurring. It may include initial and follow-up actions (e.g., conducted after root cause analysis). Current quality system models and the cGMP regulations emphasize corrective actions and require that actions be documented. Under current quality system models, preventive actions include actions taken in response to quality data to address the cause of potential nonconformities to prevent their occurrence. An effective CAPA system therefore includes both reactive and proactive components. The effectiveness of corrective and preventive actions should be evaluated using objective criteria when possible and the evaluation documented. 

Process owners must be capable to evaluate and interpret the effect of nonconformances and planned deviations on their systems. Process owners can evaluate the need and lead efforts for corrective or preventive action, ensuring adequate corrections and improvements are implemented. An effective QMS ensures deviations from approved processes are owned and adequately investigated by the process owner s and ultimately approved by their quality assurance counterpart. The knowledge of these events is the basis and foundation for the process owners to make a risk-based evaluation on whether or not process changes are required, documentation or training require modification, or continuous improvement efforts are warranted. 

When a nonconforming product is detected after delivery or use of the product has begun, the organization takes action appropriate to the effects of the nonconformity. 

Actions are taken to eliminate the cause of nonconformities in order to prevent recurrence. Suitable corrective actions are initiated to counter the effects of the nonconformities. 

The organization initiates actions to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions appropriate to the effects of the potential problem are initiated as appropriate. 

When nonconformances occur, the corrective action plan is activated. Anyone seeing the need for corrective action is responsible for reporting the problem to the proper supervisor or manager. Merely correcting the particular unsatisfactory product does not achieve corrective action. If possible, the root cause of the unsatisfactory condition is determined, and a proposed remedy is put in place. The effectiveness of the corrective action is verified. 

Establish absolute proof to substantiate each nonconformity found therefore, always seek objective evidence when nonconformity is apparent. The occurrence discovered may be the effect and not the cause. Objective evidence helps find the proof of nonconformity. 

Quality assurance functions primarily to monitor the fact that the quality function is being performed. Its role in PV is readily associated with its main functions. For example, it performs the tests that demonstrate the product s content uniformity. It may also perform the statistical evaluation of the test results to show that the process is reproducible. Quality assurance initiates the action to dispose of nonconforming product. It implements the inspection criteria and sets the specifications for product approval or rejection. It analyzes the product complaints to learn how effective its test program has been in preventing reject-able product from reaching the marketplace. 

Not dealing with situations of nonconformance in a timely and effective manner... 

First of all, an internal audit on one s own management system needs to be a solid and comprehensive approach in order to determine the effectiveness of management systems. Currently, the development shows an increased mismatch between the maturity of management systems and the stagnation of audit programs put in place to verify the system implementation, maintenance and effectiveness, thus not leading to any value-added auditing and even worse not to be able to address potential nonconformances. 

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