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Establish, implement, and maintain production process control procedures.


CONTROL ID
06209
CONTROL TYPE
Establish/Maintain Documentation
CLASSIFICATION
Preventive

SUPPORTING AND SUPPORTED CONTROLS




This Control directly supports the implied Control(s):
  • Operational management, CC ID: 00805

This Control has the following implementation support Control(s):
  • Establish, implement, and maintain a service delivery and production process Quality Management program., CC ID: 07194
  • Secure systems against unauthorized submission of production jobs., CC ID: 06738


SELECTED AUTHORITY DOCUMENTS COMPLIED WITH




  • The organization shall plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6, by: (8.1 ¶ 1, ISO 9001 Quality Management systems - Requirements, Fifth edition 2015-09-15)
  • the characteristics of the products to be produced, the services to be provided, or the activities to be performed; (8.5.1 ¶ 2(a)(1), ISO 9001 Quality Management systems - Requirements, Fifth edition 2015-09-15)
  • A medical device manufacturer shall develop, conduct, control, and monitor production processes to ensure their devices conform to specifications. When deviations could occur due to the manufacturing process, the manufacturer shall establish and maintain process control procedures to describe the pr… (§ 820.70(a), 21 CFR Part 820, Subchapter H - Medical Devices, Part 820 Quality System Regulation)
  • Determine if the quality of process design and control points are adequate for existing retail products, and if these factors are considered for new products. Consider whether: (App A Tier 1 Objectives and Procedures Objective 1:4, FFIEC IT Examination Handbook - Retail Payment Systems, April 2016)
  • Processes are automated. (App A Tier 1 Objectives and Procedures Objective 1:4 Bullet 3, FFIEC IT Examination Handbook - Retail Payment Systems, April 2016)
  • Determine if the policies reflect the current business and processes. (App A Tier 1 Objectives and Procedures Objective 4:1 Bullet 2, FFIEC IT Examination Handbook - Retail Payment Systems, April 2016)