# Presentation: 502080

## QSIT Corrective & Preventive Actions

**QSIT Workshops**

## Corrective & Preventive Actions(CAPA)

**Importance**
**Assessment**
**Data**

## Management

**Design Controls**

**Material****Controls**

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

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

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

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

**Management**

**Controls**

## 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 CAPA be Inspected?

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

## Assessment“Top Down” - Defined and Documented

**1.  CAPA system procedures**
**Address the requirements of the regulation**
**Management provides definition and interpretation of words or terms**** **

## Terms and Definitions

## Corrective Action

**Action taken to eliminate the causes of an ****existing ****non-conformity, defect or other undesirable situation in order to prevent recurrence.****	****	****	****	****	****	****     ****	****	****[ISO 8402]**

## Correction vs. Corrective Action

**“****Correction” refers to repair, rework, or adjustment and relates to the disposition of an ****existing**** nonconformity**
**“****Corrective action” relates to the elimination of the causes of nonconformity    [ISO 8402]**

## Examples 	

**Correction:  Devices returned because of out-of-box failures are repaired and put back into inventory**
**Corrective action:  Defective components damaged by ESD during assembly caused out-of-box failures. ESD controls instituted; operators are trained in ESD controls **

## Preventive Action

**Action taken to eliminate the cause of a ****potential**** non-conformity, defect, or other undesirable situation in order to prevent occurrence****	****[ISO 8402]**

## Example

**SPC charts indicate process is drifting *****toward***** upper limit for diameter of injection molded part.  Investigation determines cause of drift is wear to mold.  Replace mold, and verify/validate that process yields parts meeting specs.**

## CAPA [21CFR 820.100] Includes Actions Needed To:	

**Correct ****(“correction”)**** nonconforming product and other quality problems**
**Prevent recurrence ****(“corrective action”)**** of nonconforming product and other quality problems**
**Eliminate the cause of potential ****(“preventive action”) ****nonconforming product and other quality problems**

## Assessment“Top Down” - Implemented

**2.  ID existing problems *****(Corrective Actions)***
**Quality data sources are identified**
**Data from sources are analyzed**
**3.  ****ID potential problems *****(Preventive Actions)***
**Quality data sources are identified**
**Data from sources are analyzed**

## Assessment“Top Down” - Implemented

**4.  ****Data challenge**
**Complete**
**Accurate**
**Timely**

## Assessment“Top Down” - Implemented

**5.  ****Statistical and non-statistical techniques**
**Detect recurring quality problems**
**Results of analyses**
**compared across different data sources**
**identify and develop extent of problems**

## Assessment“Top Down” - Implemented

**6.  ****Failure Investigation**** **
**Procedures followed**
**Commensurate with significance and risk of nonconformity**
**Depth to root cause, where possible**
**Control to prevent distribution of nonconforming product**

## Assessment“Top Down” - Implemented

**7.  **_**Appropriate**_** action taken**
**8.****  Actions**
**Were effective**
**Were verified or validated**
**Do not adversely affect the finished device**

## Assessment“Top Down” - Implemented

**9.  ****Actions**
**Implemented **
**Documented**
**10. ****Information dissemination**
**Individuals directly responsible for**** **
**assuring product quality**
**prevention of quality problems**
**                                        ****	****	****	*****more...***

## Assessment“Top Down” - Implemented

**Management Review!**

## Remember?

**CAPA**

**Audits**

**Management**
**Review**

## QSIT Study Findings

## Data Sources

**Internal Feedback**
**External Feedback**

## Internal Data Sources

** ****Inspection/Test Data**
**In-Process**
**Final**
**Scrap/Yield Data**
**Process Control Data**

## Internal Data Sources

**Incoming Components**
**By Part Number**
**By Supplier**
**Equipment Data**
**Calibration**
**Maintenance**
**Internal Audits****	****	****	**
***	******	******	******	******	******	******	******more...***

## Internal Data Sources

**Device History Records**
**Training Records**
**Change Control Records**
**Rework**
**Nonconfoming Material Reports****	****	****	****	****	****	****	****	****	****	****	****	****	****	*****more...***

## External Data Sources

**Complaints**
**Customers**
**Employees**
**MedWatch**
**Field Service Reports**
**Journal Articles**
**FDA****	****	****	****	**
***	******	******	******	******	******more...***

## External Data Sources 

**Field Service Reports**
**Legal Claims**
**Product Warranty****	****	****	****	****	****	****	****	****	****	**
***	******	******	******	******	******	******more...***

## Approach to Data Analysis

**Rank areas from major to minor**
**Select items with major impact to business**
**Product related**
**Process related**
**Proceed to items with less impact**
**Assure that eventually all areas are addressed**

## Statistical Techniques

**Statistical methodologies**
**Pareto charts**
**Run charts**
**Control charts**

## Reminder!

**21CFR Part 11 - Electronic Records; Electronic Signatures**

## 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

- ... After Lunch