You must know Inspection Techniques that followed by your next Inspectors. What is QSIT (Quality System Inspection Technique).

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What is QSIT?

QSIT provides guidance to the FDA field staff on the inspection process used to assess medical device manufacturer's compliance with quality system regulations.

An FDA quality system inspection technique audit focuses primarily on four major subsystems and their respective documentation samples and is an efficient way to determine systemic weaknesses.

When an investigator conducts an FDA QSIT inspection, medical device companies can expect shorter audits and more serious repercussions---especially to upper management.

 

QSIT identifies the four major subsystems of the quality system:

a.      Management Controls,

b.      Design Controls,

c.      Corrective and Preventive Actions (CAPA),

d.     Production and Process Controls.

 

QSIT Management Controls

Inspectional Objectives

1. Verify that a quality policy, management review and quality audit procedures, quality plan, and quality system procedures and instructions have been defined and documented.

2. Verify that a quality policy and objectives have been implemented.

3. Review the firm's established organizational structure to confirm that it includes provisions for responsibilities, authorities and necessary resources.

4. Confirm that a management representative has been appointed.  Evaluate the purview of the management representative.

5. Verify that management reviews, including a review of the suitability and effectiveness of the quality system, are being conducted.

6. Verify that quality audits, including re-audits of deficient matters, of the quality system are being conducted.

At the conclusion of the inspection....

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

OSIT Design Controls

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Inspectional Objectives

1. Select a single design project.

Note: If the project selected involves a device that contains software, consider reviewing the software's validation while proceeding through the assessment of the firm's design control system.

2. For the design project selected, verify that design control procedures that address the requirements of Section 820.30 of the regulation have been defined and documented. 3. Review the design plan for the selected project to understand the layout of the design and development activities including assigned responsibilities and interfaces.

Note: Evaluate the firm's conduct of risk analysis while proceeding through the assessment of the firm's Design Control system.

4. Confirm that design inputs were established.

5. Verify that the design outputs that are essential for the proper functioning of the device were identified.

 6. Confirm that acceptance criteria were established prior to the performance of verification and validation activities.

7. Determine if design verification confirmed that design outputs met the design input requirements.

8. Confirm that design validation data show that the approved design met the predetermined user needs and intended uses.

9. Confirm that the completed design validation did not leave any unresolved discrepancies.

10. If the device contains software, confirm that the software was validated.

11. Confirm that risk analysis was performed.

12. Determine if design validation was accomplished using initial production devices or their equivalents.

13. Confirm that changes were controlled including validation or where appropriate verification.

14. Determine if design reviews were conducted.

15. Determine if the design was correctly transferred.

 

QSIT Corrective and Preventive Actions (CAPA)

Inspectional Objectives

1. Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented.

2. Determine if appropriate sources of product and quality problems have been identified.  Confirm that data from these sources are analyzed to identify existing product and quality problems that may require corrective action.

3. Determine if sources of product and quality information that may show unfavorable trends have been identified.  Confirm that data from these sources are analyzed to identify potential product and quality problems that may require preventive action.

4. Challenge the quality data information system.  Verify that the data received by the CAPA system are complete, accurate and timely.

5. Verify that appropriate statistical methods are employed (where necessary) to detect recurring quality problems.  Determine if results of analyses are compared across different data sources to identify and develop the extent of product and quality problems.

6. Determine if failure investigation procedures are followed.  Determine if the degree to which a quality problem or nonconforming product is investigated is commensurate with the significance and risk of the nonconformity.  Determine if failure investigations are conducted to determine root cause (where possible).  Verify that there is control for preventing distribution of nonconforming product.

7. Determine if appropriate actions have been taken for significant product and quality problems identified from data sources.

8. Determine if corrective and preventive actions were effective and verified or validated prior to implementation. Confirm that corrective and preventive actions do not adversely affect the finished device.

9. Verify that corrective and preventive actions for product and quality problems were implemented and documented.

10. Determine if information regarding nonconforming product and quality problems and corrective and preventive actions has been properly disseminated, including dissemination for management review.

 

 

QSIT Production and Process Controls

Inspectional Objectives

1. Select a process for review based on:

a. CAPA indicators of process problems;

b. Use of the process for manufacturing higher risk devices;

 c. Degree of risk of the process to cause device failures;

d. The firm’s lack of familiarity and experience with the process;

e. Use of the process in manufacturing multiple devices;

 f. Variety in process technologies and Profile classes;

g. Processes not covered during previous inspections;

h. Any other appropriate criterion as dictated by the assignment

Note:  If the process chosen is sterilization, evaluate the process according to the “Sterilization Process Controls” chapter of this handbook.

2. Review the specific procedure(s) for the manufacturing process selected and the methods for controlling and monitoring the process.  Verify that the process is controlled and monitored.

Note:  Control and monitoring procedures may include in-process and or finished device acceptance activities as well as environmental and contamination control measures.

3. If review of the Device History Records (including  process control and monitoring records, etc.) reveals that the process is outside the firm’s tolerance for operating parameters and/or rejects or that product nonconformance’s exist:

a. Determine whether any nonconformance’s were handled appropriately;

b. Review the equipment adjustment, calibration and maintenance; and

c. Evaluate the validation study in full to determine whether the process has been adequately validated.

 

4. If the results of the process reviewed cannot be fully verified, confirm that the process was validated by reviewing the validation study.

5. If the process is software controlled, confirm that the software was validated.

6. Verify that personnel have been appropriately qualified to implement validated processes or appropriately trained to implement processes which yield results that can be fully verified.

 

Source: GUIDE TO INSPECTIONS OF QUALITY SYSTEMS GUIDE TO INSPECTIONS OF QUALITY SYSTEMS August 1999

“Trust but Verify “ Ronald Reagan

 

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