content material: Subpart A. common provisions --
subpart B. caliber procedure standards --
subpart C. layout controls --
subpart D. rfile controls --
subpart E. buying controls --
subpart F. identity and traceability --
subpart G. construction and method controls --
subpart H. popularity actions --
subpart I. Nonconforming product --
subpart J. Corrective and preventive motion --
subpart okay. Labeling and packaging keep an eye on --
subpart L. dealing with, garage, distribution, and set up --
subpart M. documents --
subpart N. Servicing --
subpart O. Statistical techniques.
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Extra info for Code of federal regulations 21 : part 820 : quality system regulation
65, that control number shall be on or shall accompany the device through distribution. 130 Device packaging. Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution. 140 Handling. Each manufacturer shall establish and maintain procedures to ensure that mixups, damage, 36 PH2208_Pages 10/8/03 9:31 AM Page 37 deterioration, contamination, or other adverse effects to product do not occur during handling.
Each manufacturer shall identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria. The identification of acceptance status shall be maintained throughout manufacturing, packaging, labeling, installation, and servicing of the product to ensure that only product which has passed the required acceptance activities is distributed, used, or installed. 90 Nonconforming product. (a) Control of nonconforming product. Each manufacturer shall establish and maintain 32 PH2208_Pages 10/8/03 9:31 AM Page 33 procedures to control product that does not conform to specified requirements.
Disposition of nonconforming product shall be documented. Documentation shall include the justification for use of nonconforming product and the signature of the individual(s) authorizing the use. (2) Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the DHR.