Manufacturers shall establish in writing and maintain procedures for identification, collection, indexing, access, filing, storage, maintenance and disposition of quality records.
Quality records and their control shall conform to the following rules:
(1) Quality records shall be maintained to demonstrate conformance to specified requirements and the effective operation of the quality system.
(2) Pertinent quality records from the subcontractor shall be an element of this data.
(3) Retention times of quality records shall be clearly defined, and shall be at least equivalent to the lifetime of the medical device, but not less than two years from the date of dispatch from the manufacturer.
(4) Quality records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage, deterioration and loss.
(5) Where agreed contractually, quality records shall be made available for evaluation by the customer for an agreed period.
Article 151. Manufacturers shall establish and maintain a record for each batch of medical devices that provides traceability and identifies the quantity manufactured and quantity approved for distribution.
The batch record referred to in the preceding Paragraph shall be verified and authorized.
Chapter 18 Internal Quality Audits
Article 152. Manufacturers shall establish in writing and maintain procedures for planning and implementing internal quality audits to verify whether quality activities and related results comply with planned arrangements and to determine the effectiveness of the quality system.
Article 153. Internal quality audits shall be scheduled by manufacturers on the basis of the status and importance of the activity to be audited, and shall be carried out by personnel independent of those having direct responsibility for the activity being audited.
The results of the audits shall be recorded and brought to the attention of the personnel having responsibility in the area audited. The management personnel responsible for the area shall take timely corrective action on the deficiencies found during the audit.
Follow-up activities shall be carried out to verify and record the implementation and effectiveness of the corrective action taken.
Chapter 19 Training
Article 154. Manufacturers shall establish in writing and maintain procedures for identifying training needs and provide for the training of all personnel performing activities affecting quality; personnel performing specific assigned tasks shall be qualified on the basis of appropriate education, training or experience, as required.
Appropriate records of the training referred to in the preceding Paragraph shall be maintained.
Chapter 20 Servicing
Where servicing is a specified requirement, the manufacturer shall establish in writing and maintain procedures for performing, verifying and reporting that the servicing meets the specified requirements.
Chapter 21 Statistical Techniques
Article 156. Manufacturers shall identify the need for statistical techniques required for establishing, controlling and verifying process capability and product characteristics.
Manufacturer shall establish in writing and maintain procedures to implement and control the application of the statistical techniques referred to in the preceding Paragraph.
Part 5 Supplementary Provisions
Article 157. This set of Standards shall come into force from the date of announcement.
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