# Presentation: 243829

## QSIT Management Controls

**QSIT Workshops**

## Management Controls

**Importance**
**Assessment **
**Demonstration of Compliance**

## Quality System

**Quality System**

**Design Controls**

**Material****Controls**

**Records,**** Documents, &**
**Change Controls**

**Equipment & **
**Facility Controls**

**Production & **
**Process Controls**

**Corrective &**
**Preventive**
**Actions**

**Management**

## Top Ten FDA 483 Items

**Top Ten FDA 483 Items**

**Records (20%)**

**CAPA (50%)**

**PAPC (30%)**

**Non-QSIT Inspections**

## Top Ten FDA 483 Items

**QSIT Inspections**

**CAPA (30%)**

**PAPC (20%)**

**Records (10%)**

**Mgmt (40%)**

**Top Ten FDA 483 Items**

## QSIT Progression

***1.  Management Controls***
**2.  Design Controls**
**3.  Corrective and Preventive Actions**
**4.  Production and Process Controls**
***5.  Management Controls***

## How Will Management be Inspected?

**QSIT Guide**
**Purpose and Importance**
**Objectives**
**Flow chart**
**Narratives**

## Assessment“Top Down”  - Defined and Documented

**1. Quality Policy**
**    ****Management Review Procedures**
**    ****Quality Audit Procedures**
**    ****Quality Plan**
**    ****QS Procedures and Instructions**

## Assessment“Top Down” - Implemented

**2.  Quality Policy and Objectives**
**3.  Organizational Structure**
**4.  Management Representative**
**5.  Management Reviews**
**6.  Quality Audits**

## Assessment“Top Down” (At Inspection Conclusion)

**7.  Quality System Established and **
**     ****Maintained**

## QSIT Study Findings

## Terms and Definitions

## Management with Executive Responsibility - 820.3(n)

**Those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer’s quality policy and quality system**
**Possess responsibility, authority and power**

## Management Representative  820.20(b)(3)

**Has established authority over and responsibility for:**
**Ensuring the quality system requirements are effectively established and maintained**
**Reporting on the performance of the quality system to management with executive responsibility to review****	****	**

## Quality Policy - 820.3(u)

**The overall intentions and direction of an organization with respect to quality**
**As established by management with executive responsibility**

## Quality System - 820.3(v)

**The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management**

## FDA’s Authority to Hold Management Responsible

**FD&C Act - Section 704(a)(1)**
**21 CFR 820.20**
**Case Law - Dotterweich & Park**
**FDA will determine authority and responsibility to the highest level of the firm as well as the corporation or organization.**

## Delegation by Management with Executive Responsibility

**Establishment of quality objectives**
**Translation of objectives into methods and procedures**
**Implementation of quality system**

## Responsibility of Highest Level of Management

**Establish Quality Policy**
**Ensure that it is followed**

## How to Demonstrate Compliance

**Procedures ...**
**Verbal Communications**
**Written records and documents**

## Establish [21CFR 820.3(k)]

**Define **
**Document **
**Implement**

## What FDA Evaluates 

**Duties**
**Responsibilities**
**Authorities**

## Procedures ... FDA Looks At

**Quality Policy**
**Quality Plan**
**Management Review**
**Quality Audit**
**Quality System Procedures and Instructions**

## Verbal Communications FDA “Looks At”

**Management with Executive Responsibility**
**Commitment to quality**
**Dialogue during daily “wrap-ups”**
**Commitment to correction and prevention**

## Verbal Communications FDA “Looks At”

**Management Representative****	**
**Interviewed prior to review of each subsystem****	**
**Provide overview of each subsystem**
**Demonstrate knowledge and understanding of each subsystem****	**
**Dialogue during daily “wrap-ups”****	**

## Verbal Communications FDA “Looks At”

**Employees **
**Familiar with the Quality Policy**
**Other dialogue**

## Written Records/ Documents FDA Looks At

**Organizational Structure**
**Appointment of Management Representative**

## Written Records/ Documents FDA Looks At

**Documentation that audits were conducted as scheduled.**
**Documentation that management reviews were conducted as scheduled.**

## FDA Access to Audit and Management Review Reports

**FDA’s policy relative to the review of quality audit reports is stated in CPG 7151.02 (CPG Manual subchapter 130.300).**
**This policy restricts FDA access to a firm’s audit reports.****                                               *****more...***

## FDA Access to Audit and Management Review Reports

**Under the Quality System Regulation, this restriction extends to reviews of supplier audit reports and management reviews.****	****	****	****	****	****	****	****	****	*****more...***

## FDA Access to Audit and Management Review Reports

**However, the ****procedures**** that show conformance with 21 CFR 820.50, Purchasing Controls, and 21 CFR 820.20(3)(c), Management Reviews, and 21 CFR 820.22, Quality Audit, ****are subject to FDA inspection.**

## FDA Access to Audit and Management Review Reports 

**FDA may look at those portions of these audit reports and reviews that contain corrective and preventive actions if these are the only places these action decisions are documented.**

## How does Management Assure an Effective Quality System?

**CAPA**

**Audits**

**Management**
**Review**

## At the Conclusion of the Inspection ...

**  “****Evaluate whether management with executive responsibility ensures that an adequate and effective quality system has been established and maintained.”**

## Exercise