QSR Required Procedures


I have identified 40 procedures required by 21 CFR 820: the Quality System Regulation

  1. § 820.22 for quality audits…
  2. § 820.25(b) for identifying training needs…
  3. § 820.30(a)(1) to control the design of the device in order to ensure that specified design requirements are met
  4. § 820.30(c) to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient
  5. § 820.30(d) for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements
  6. § 820.30(e) to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development
  7. § 820.30(f) for verifying the device design
  8. § 820.30(g) for validating the device design
  9. § 820.30(h) to ensure that the device design is correctly translated into production specifications
  10. § 820.30(i) for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation
  11. § 820.40 to control all documents that are required by this part
  12. § 820.50 to ensure that all purchased or otherwise received product and services conform to specified requirements
  13. § 820.60 for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups
  14. § 820.65 for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components
  15. § 820.70(a) that describe any process controls necessary to ensure conformance to specifications
  16. § 820.70(b) for changes to a specification, method, process, or procedure
  17. § 820.70(c) to adequately control these environmental conditions
  18. § 820.70(e) to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality
  19. § 820.70(h) for the use and removal of such manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the device’s quality
  20. § 820.72(a) to ensure that equipment is routinely calibrated, inspected, checked, and maintained
  21. § 820.75(b) for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met
  22. § 820.80(a) for acceptance activities
  23. § 820.80(b) for acceptance of incoming product
  24. § 820.80(c) to ensure that specified requirements for in-process product are met
  25. § 820.80(d) for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria
  26. § 820.90(a) to control product that does not conform to specified requirements
  27. § 820.90(b)(1) that define the responsibility for review and the authority for the disposition of nonconforming product
  28. § 820.90(b)(2) for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications
  29. § 820.100(a) for implementing corrective and preventive action
  30. § 820.120 to control labeling activities
  31. § 820.140 to ensure that mixups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling
  32. § 820.150(a) for the control of storage areas and stock rooms for product to prevent mixups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed
  33. § 820.150(b) that describe the methods for authorizing receipt from and dispatch to storage areas and stock rooms
  34. § 820.160(a) for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution
  35. § 820.170(a) for ensuring proper installation so that the device will perform as intended after installation
  36. § 820.184 to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part
  37. § 820.198(a) for receiving, reviewing, and evaluating complaints by a formally designated unit
  38. § 820.200(a) for performing and verifying that the servicing meets the specified requirements
  39. § 820.250(a) for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics
  40. § 820.250(b) to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed
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