# Presentation: 329899

## The Quality System Inspection Technique: “QSIT”

**QSIT Workshops**

## Introduction

**What is QSIT?**
**How we inspect with QSIT**
**QSIT findings**
**Implementing QSIT**

## What is QSIT?

**Moves FDA closer to Global Harmonization guideline for regulatory auditing of quality systems of medical device manufacturers**
**Incorporates the seven subsystems concept**
**Provides specific guidance on auditing each subsystem**

## Quality System’s Sub-systems

**Quality System’s Sub-systems**

**Design Controls**

**Material****Controls**

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

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

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

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

**Management**

**Major Themes of QSIT**

## Theme #1 = Management

**Management is responsible for Implementing Quality System**
**Start & Finish with Management**
**All product, process, design & CAPA problems can be tied to management**

## Inspection Conclusion

**“****Did management ensure that an adequate and effective Quality System has been established?”  (Mgt. #7)**

## Theme #2 = CAPA

**We are checking the “system” **
**Non-conformances happen**
**What kind of system does the firm have?**
**Is the system effective?**

## Design Controls

**Design Controls**

**Material****Controls**

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

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

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

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

**Management**

## Management

**Management**

**Controls**

**Design Controls**

**Material****Controls**

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

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

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

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

## The Inspection Approach 

**Top-down (versus Bottom-up)**
**Sampling records (use tables)**
**Pre-inspection activities (ask for and review documents)**
**Start and end with Management**

## MANAGEMENT

**MANAGEMENT**

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

**Material Controls**

**Records/**
**Documents/**
**Change Controls**

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

**Design**
**Controls**

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

**Sterilization Process Controls**

**Medical Device Tracking**

**Reports of Corrections and Removals**

**Medical Device Reporting**

## How Will Each Subsystem be Inspected?

**QSIT Guide**
**Purpose and Importance**
**Objectives**
**Flow charts**
**Narratives**
**Sampling Plans**

## Establish - [21CFR 820.3(k)]

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

## The “Establish” Test

**Proof of “Establish”**
**Is the firm doing what regulation says?**
**Is the firm doing what their procedure says?**

## Proof of “Establish”
Is the firm doing it adequately? 
Bore down...using:
Vertical Probes
Sampling 

**Is the firm doing it adequately? **
**Bore down...using:**
**Vertical Probes**
**Sampling **

**The “Establish” Test**

## Order of Systems

**Management**
**Design**
**CAPA**
**Production & Process Controls**
**Conclude with Management**

## QSIT Findings In-Plant Time

**QSIT Findings**** In-Plant Time**

**Coverage**

**Average Hours**

## QSIT FDA 483’s 

**QSIT FDA 483’s**** **

**Number of Items**

**QSIT Subsystem**

**200 Total (FDA 483) Items**

## QSIT Inspection Classifications

## Implementing QSIT

**Training on-going**
**Compliance Program**
**Industry Workshops**
**Monitoring and Improvements**

## Compliance Program

**Incorporates Several Program areas**
**Utilizes QSIT **
**Uses Three Levels of Inspection**
**Establishes OAI **

## HACCP vs. QSIT
QSIT is NOW
HACCP is FUTURE
HACCP is being tested.
Possible role is..........

**QSIT is NOW**
**HACCP is FUTURE**
**HACCP is being tested.**
**Possible role is..........**

**One Last Item................**

## For Further Information

**	****Tim Wells or Chris Nelson **
**	****Quality System Inspections Reengineering Team **
**	****2094 Gaither Road, HFZ-300****Rockville, Maryland, USA 20850**
**	****301-594-4611**

## QSIT Website:
www.fda.gov/cdrh/gmp/gmp.html

QSIT Study:
www.fda.gov/cdrh/gmp/qsit-study.pdf

QSIT “Guide”:
www.fda.gov/cdrh/gmp/qsitbook.html
Changed to.......

**www.fda.gov/cdrh/gmp/gmp.html**
**QSIT Study:**
**www.fda.gov/cdrh/gmp/qsit-study.pdf**
**QSIT “Guide”:**
**www.fda.gov/cdrh/gmp/qsitbook.html**
**Changed to.......**

**For Further Information**

## Thank You