10.2 Nonconformity and corrective action

Control of nonconforming products 

Nonconforming products are identified and controlled using procedure Control of nonconforming product which defines activities and responsibilities for dealing with nonconforming product. 

The analysis of detected nonconformity is conducted in order to define the measure to eliminate the nonconformity. Nonconformity can be resolved by repairing and in some cases by using non-conforming product but under concession (to be agreed with the customer or authorities if applicable).

Repaired product (e.g. software) is subjected to the re-verification procedure as defined by product realization procedure and test planning before delivery take place.

If nonconforming product can not be repaired or used as it is, it is marked as non-conforming.

Records related to the nature of the nonconformity and actions taken are maintained.

Corrective Measures
The R-Tech/EU-VRi corrective measures procedure define the means by which an issue which causes or may/can cause a quality-related problem will be reported, identified and systematically tackled. The originator of the procedure PM defines the problem and QMG assigns the responsible for resolution. Corrective Action Requests are documented in the QMS Records on the R-Tech/EU-VRi portal and maintained for a minimum of one year. The originator of the procedure is responsible for verifying the effectiveness of measures and the QMG periodically audits for the same. All forms of customer complaints (SPS-TR) are captured and maintained within the R-Tech/EU-VRi corrective measures process to assure effective actions are taken and responses provided.

Preventive Measures
Management reviews product and process data identifying potential problems, their causes and determining the action required to eliminate the possibility of occurrence. Preventative measures are documented utilizing R-Tech/EU-VRi’s documented Corrective and Preventive Measues procedure.

All R-Tech/EU-VRi associates are encouraged to analyze the need for preventative action when implementing or changing actions or functions.

MANL: Measurements, Analysis & Improvement

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