Acceptance Activities in FDA's Quality Management System
Duration: 90 Minutes
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FDA Warning Letters frequently cite acceptance activities, suggesting that device manufacturers may have implementation problems. This section is in the top ten Warning Letter citations. To avoid a 483 and a Warning Letter, you must understand the QSR requirements and implement them. This presentation explains the regulation, guides you to take action, and uses Warning Letters to illustrate problems.
This section plays a major role in both purchasing and in production. It is a major contributor to determine whether your supplier and manufacturing process are working effectively. Acceptance activities determine whether you can release finished goods for distribution.
Effective acceptance activities require well-written procedures, trained employees, and correct quality records. In addition, there is a major role that involves sampling, §820.250(b), acceptance status, §820.86, and nonconforming product, §820.90.
Objectives of the Presentation
As you ensure that your Quality Management System meets FDA's regulations, you need robust acceptance activities. A gap could result in a Warning Letter, but even worse, it could also create a recall. This presentation provides the implementation information as well as the audit strategy to help verify your processes.
Who will Benefit
People in the following roles can especially benefit from the information in this presentation:
Participants receive a checklist to help assure conformance with QSR requirements for Acceptance Activities
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Download AgendaEffective acceptance activities require well-written procedures, trained employees, and correct quality records. In addition, there is a major role that involves sampling, §820.250(b), acceptance status, §820.86, and nonconforming product, §820.90.
Objectives of the Presentation
- Learn some of the specialized terms from QSR
- Understand how purchasing and acceptance activities are linked and combine to facilitate effective supplier management
- Provide guidance on when in-process acceptance activities are required
- Understand the required activities to release a finished device for distribution
- Know the acceptance activity records to keep and how they relate to Device History Record (DHR)
- Understand the role of sampling plans in acceptance activities
- Know the competence requirements for people who perform acceptance activities
As you ensure that your Quality Management System meets FDA's regulations, you need robust acceptance activities. A gap could result in a Warning Letter, but even worse, it could also create a recall. This presentation provides the implementation information as well as the audit strategy to help verify your processes.
Who will Benefit
People in the following roles can especially benefit from the information in this presentation:
- Design Engineers, especially those involved in Design Transfer
- Operations Managers
- Production Managers
- Production Supervisors
- Purchasing Managers
- Purchasing Agents
- Quality Managers
- Quality Engineers
- Manufacturing Engineers
Participants receive a checklist to help assure conformance with QSR requirements for Acceptance Activities