Title: Why are Records Retrieved and Reviewed?
Course: PW-Course-Import-Test > Section: Module 6: Quality Records

Module 6

Quality Records provide objective evidence that required activities were performed in accordance with Quality System documentation. Regulators who may come to inspect a medical device firm have zero first hand knowledge of what activities actually took place during (for example) the manufacturing process.

During an FDA inspection, Quality records will be requested and reviewed to provide evidence that required activities took place as documented and specified. Subordinate Quality Records that support a recorded activity will also be reviewed. This review process forms an “inspection thread” that will be followed - in some cases all the way to the beginning of the activity that is under review. Compliance “gaps” within the inspection thread are a common source of FDA citations - hence the findings “Procedures not established” or “Procedure not followed”.

Record retention, preservation and retrieval is highly relevant during third party inspections/FDA investigations. Producing records/objective evidence to support review of previously required activities is a compliance imperative. Later in this section we will explore the consequences of non-compliance to this section of the regulation.

The FDA provides Quality Records also. Form 482 and 483 are Quality Records that are issued to a manufacturing company and subsequently become a quality record that is included in the company’s quality records process.

As another example, the FDA provides a Quality Record to firms upon closure of a site investigation. This record is called an Establishment Inspection Report (EIR).

Read

Read Establishment Inspection Report to see an example of a detailed and comprehensive report.