General Principles
Non-conform Product Control
Generalities
The supplier should establish and keep documented procedures to ensure that the product non-conform specified requirements has preceded its usage of non-intentional installation. This control should offer identification, documentation, evaluation, segregation (whenever applicable), non-conform product disposition and notification of involved functions.
Critical analysis and disposition of non-conform products
The responsibility for a critical analysis and the authority for non-conform product disposition should be defined.
The non-conform product should be critically analyzed according to documented procedures. The product may be:
a) rework to supply specified requirements;
b) accept with out without repair, by means of concession;
c) classified by alternative applications;
d) rejected or scrapped.
When required by contract, the proposed product usage or repair that does not agree with the specified requirements should be related to the customer or representative, for concession. The accepted non-conformity description that is accepted and the repairs should be registered to indicate the real condition.
The rework and/or repaired product should be reinspected, according to the quality plan and/or procedures documented.
Corrective Action and Preventive Action
Generalities
The supplier should establish and maintain documented procedures for the implementation of corrective and preventive actions.
Any actions, corrective or preventive, taken to delete real or potential non-conformity causes, should be in appropriate degree to the size of the problems and proportional to the found risks.
The supplier should implement and register any changed to the documented procedures found on corrective and preventive actions.
Corrective Action
Corrective action procedures should have:
| • | Effective treatment of customer complaints and product non-conformity reports. |
| • | Investigation of non-conformity causes related to product, process and quality system, and the registration of investigation results. |
| • | Determination of corrective action necessary to delete the non-conformity cause. |
| • | Application of controls to ensure that effective corrective actions are in place. |
Preventive Action
Preventive action procedures should have:
| • | Usage of appropriate sources of information, such as work processes and operations that affect the quality of the product, concessions, audit results, quality registers, service reports and customer complaints, to detect, analyze and delete potential non-conformity causes. |
| • | Determination of the necessary steps to deal with any problems that require preventive action. |
| • | Start a preventive action and control application to ensure the action is effective. |
| • | Ensure relevant information on actions taken is subjected to critical analysis by the management. |