Manufacturers shall establish in writing and maintain procedures for the control of all documents and data governed by the provisions of this Part; where feasible, said procedures shall include original documents of external origin (such as standards and client drawings)
Document and data control by manufacturers shall comply with the following conditions:
(1) Documents and data shall be reviewed and approved for adequacy by authorized personnel prior to issue.
(2) A master list or equivalent document control procedure identifying the current revision status of documents shall be established and be readily available to prevent the use of obsolete or invalid documents.
(3) Valid versions of appropriate documents shall be made available at all locations where operations essential to the effective functioning of the quality system are performed.
(4) Obsolete or invalid documents shall be promptly removed from all points of issue or use, or other steps shall be taken to ensure that inadvertent use does not occur.
(5) Obsolete documents retained for legal or information purposes shall be appropriately identified.
(6) Manufacturers shall retain at least one copy of obsolete control documents, and shall determine the period of retention. Said period shall be sufficient to ensure that the specifications to which medical devices have been manufactured are available for at least the specified usage period of said products.
Article 119. Alterations to documents shall, unless otherwise designated, be reviewed and approved by the same functional units/organizations that performed the original review and approval. If other functional units/organizations are assigned to review said alterations, said units/organizations shall have access to background information used in the original review upon which to base their review and approval.
Where feasible, the nature of the alteration shall be indicated in the document or an appropriate attachment.
Chapter 7 Purchasing
Article 120. Manufacturers shall establish in writing and maintain purchasing procedures to ensure that all products purchased comply with specified requirements.
Purchasing documents shall clearly describe the products being purchased; where feasible, said documents shall include the following items:
(1) Product type, class, grade or other precise identifying information;
(2) Product name or other proper identification and applicable versions of specifications, graphics, process requirements, inspection instructions and other relevant technical data, including items required for product, procedure, process equipment and personnel approval or validation;
(3) Name, serial number and version of the quality system standard used.
Where it is necessary to verify a purchased product on the subcontractor’s premises, verification arrangements and the method of product release shall be specified in the purchasing documents.
Manufacturers shall review and approve purchasing documents for adequacy of specified requirements prior to release.
In accordance with the provisions of Chapter 9, for medical devices with specified traceability requirements, manufacturers shall retain copies of relevant purchasing documents.
Article 121. Manufacturers shall adopt the following measures in regard to subcontractors:
(1) Evaluate and select subcontractors based on their ability to meet subcontracting requirements, including quality system and specific quality assurance requirements.
(2) Define the method and extent of control exercised over subcontractors based on product type and impact of subcontracted product on quality of end product; where applicable, the subcontractor’s quality audit reports or quality records demonstrating the subcontractor’s capabilities and performance shall be consulted.
(3) Establish and maintain subcontractor quality records.
Manufacturers shall not take testimonials from clients regarding subcontractors as evidence for use in effective subcontractor quality control.
Chapter 8 Control of Customer-supplied Products
Article 122. Manufacturers shall establish in writing and maintain procedures for control of the verification, storage and maintenance of customer-supplied products.
Customer-supplied products, as referred to in the preceding Paragraph, are supplies provided by customers that are incorporated into products or used in related activities. Where customer-supplied products are lost, damaged or otherwise unsuitable for use, the manufacturer shall record the problem and report it to the customer.
Chapter 9 Product Identification and Traceability
Article 123. Where appropriate, manufacturers shall establish in writing and maintain procedures detailing suitable means for identifying their products at the various stages of receiving, production, delivery and installation.
The procedures described in the preceding Paragraph shall include instructions ensuring that where returned medical devices are reprocessed due to special requirements, said products are properly identified and differentiated at all times.
Article 124. For products where traceability is required, manufacturers shall establish in writing and maintain procedures to ensure unique identification of individual products or product batches. Records shall be kept of said identification.
Manufacturers shall establish and maintain traceability procedures; said procedures shall define the extent of traceability and facilitate corrective and preventive measures.
The extent of traceability for active implantable medical devices and implantable medical devices shall include records of all components, materials and environmental conditions that could possibly prevent said devices from complying with specified requirements.
Manufacturers shall require that their agents or distributors maintain and retain medical device sales records for inspection purposes.
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