Manufacturers shall establish in writing and maintain procedures for implementing corrective and preventive actions.
Any corrective or preventive action taken to eliminate the causes of actual or potential nonconformities shall be to a degree appropriate to the magnitude of problems and commensurate with the risks encountered.
Manufacturers shall implement and record any changes to the documented procedures resulting from corrective and preventive actions.
Manufacturers shall establish in writing and maintain a feedback system to provide early warning of quality problems and for input into corrective and preventive action systems.
Manufacturers shall gain experience through monitoring of post-production phase feedback data; the review of this experience shall form part of the feedback system.
Manufacturers shall maintain records of all customer complaint investigations. When the investigation determines that the activities at remote premises contributed to the customer complaint, relevant information shall be communicated between the manufacturer and the remote premises.
If any customer complaint is not followed by corrective and preventive action, the reason shall be recorded.
Manufacturers shall establish reporting procedures governing notification of the central competent health authority when injuries involving medical devices occur.
Manufacturers shall establish, document and maintain procedures for the issue of advisory notices for medical devices. These procedures shall be capable of being implemented at any time.
Article 146. The procedures for corrective action shall include the following:
(1) The effective handling of customer complaints and reports of product nonconformities;
(2) Investigation of the causes of nonconformities relating to product, process and quality system, and recording the results of the investigation;
(3) Determination of the corrective action needed to eliminate the cause of nonconformities;
(4) Application of controls to ensure that corrective action is taken and that it is effective.
Article 147. The procedures for preventive action shall include the following:
(1) The use of appropriate sources of information such as process and work operations which affect product quality, concessions, audit results, quality records, service reports and customer complaints to detect, analyze and eliminate potential causes of nonconformities;
(2) Determination of the steps needed to deal with any problems requiring preventive action;
(3) Initiation of preventive action and application of controls to ensure that it is effective;
(4) Ensuring that relevant information on actions taken is submitted for management review.
Chapter 16 Handling, Storage, Packaging, Preservation and Delivery
Manufacturers shall establish in writing and maintain procedures for handling, storage, packaging, preservation and delivery of products.
Manufacturers shall establish in writing and maintain procedures governing medical device shelf life or special storage conditions. Said conditions shall be controlled and recorded. If appropriate, special arrangements shall be established, documented and maintained for the control of used products in order to prevent contamination of other products, the manufacturing environment or personnel.
Article 149. Manufacturers shall carry out handling, storage, packaging, preservation, and delivery of products in accordance with the following rules:
(1) Handling: methods of handling products that prevent damage or deterioration shall be used.
(2) Storage: designated storage areas or stock rooms shall be used to prevent damage or deterioration of product, pending use or delivery; appropriate methods for authorizing receipt to and dispatch from said areas shall be stipulated; the condition of products in stock shall be assessed at appropriate intervals in order to detect deterioration.
(3) Packaging: packing, packaging and marking processes (including materials used) shall be controlled to the extent necessary to ensure conformance to specified requirements; the identity of persons who perform the final labeling operation for active implantable medical devices and implantable medical devices shall be recorded.
(4) Preservation: appropriate methods for preservation and segregation of products when said products are under the manufacturer’s control.
(5) Delivery: arrangements shall be made to protect the quality of products after final inspection and test; where contractually specified, this protection shall extend to include delivery to destination; the name and address of the shipping package consignee shall be included in the quality records for active implantable medical devices and implantable medical devices.
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