1. Corrective and Preventive Action
By Superlative BioSciences Corporation
October 13, 2007

2. What is CAPA?
Corrective and Preventative Action (CAPA) is a system of quality procedures required to eliminate the causes of an existing nonconformity and to prevent recurrence of nonconforming product, processes, and other quality problems.

3. Regulatory Guidance
“Corrective and Preventive Action,” Quality System Regulation (QSR), 21 CFR Part 820, Medical Devices, Subpart J, Sec. 100, Became effective on June 1, 1997, Replacing the 1978 GMP for Medical Devices.
“Overview of the Quality System Regulation for Medical Devices,” Kimberly Trautman – Food and Drug Administration, USA and Chair, Study Group 3, June 29, 1999.
“QSIT Corrective & Preventive Actions,” Quality System Inspection Techniques (QSIT) Guide, August 1999.
“Establishment and Maintenance of a Quality Program.” Human Cells, Tissues, And Cellular And Tissue-Based Products (HCT/P's), 21 CFR Part 1271 Subpart D, Current Good Tissue Practice (cGTP), Sec. 160, May 25, Revised as of April 1, 2006,

4. Terminology
Nonconforming Material or Process (Discrepancy) - Any material or process that does not meet its required specifications or documented procedure.
Correction – Refers to repair, rework, or adjustment and relates to the disposition of an existing nonconformity.
Corrective Action - To identify and eliminate the causes of existing nonconforming product and other quality problems.
Preventive Action - To identify and eliminate the causes of potential nonconforming product and other quality problems.

5. Seven Quality Subsystems

6. Components Of Corrective And Preventive Action
(CAPA)
Collect and analyze data to identify nonconforming
product and other quality problems
Investigate cause
Identify and implement corrective and preventive action
Verify or validate effectiveness

7. Components Of Corrective And Preventive Action
(CAPA)
Communicate information about quality problems,
changes made, outcomes, and trends to those persons directly responsible and to the staff in general
Forward information for management review
Work with staff and management to produce continuous quality improvement

8. Quality Data Sources

9. CAPA Case Studies Weak CA, Weak PA (Common)
Weak CA, Strong PA (Unusual)
Strong CA, Weak or Unlinked PA (Common)
Strong PA Linked to a Strong CA (Ideal)

10. Case Study No. 1 The company develops biopharmaceuticals
The company has a CAPA program
A review of existing internal and external audits reveal that:
nonconformities are documented
corrections are proposed (a temporary or permanent change, repair, rework, or scrap)
corrections made are timely
but the same nonconformities seem to reoccur over and over again
customers are complaining

11. The current investigation indicates that:
nonconformities are not adequately categorized and trended
the root causes of existing nonconformities are not adequately investigated or addressed
preventive actions are not sufficient to eliminate the reoccurrence of the nonconformity
discrepancy and CAPA procedures are not well-written or difficult to follow
the forms utilized don’t follow the flow of the procedure
the forms do not provide enough space for more than a brief entry
verbal decisions are not written down
responsible people are assigned but a timelines for the follow-ups is not given or is vague

12. The Solution
Revise all Quality Assurance Procedures to emphasize CAPA and to link discrepancy reporting and disposition to preventive action
Initiate a trending and root cause analysis program
Present these programs to management and to the staff
Revise the nonconformity, CA, and PA forms
Conduct formal CAPA training
Reinforce CAPA awareness in verbal communications
Provide a “Quality Update” at the company’s monthly
staff meeting

13. The Results Easier to follow quality procedures
More user-friendly forms
A better understanding of processes obtained through root cause analysis
More proactive thinking vs. reactive thinking
Fewer nonconformities
Less scrap and rework
Fewer customer complaints

14. Pre-CAPA
Post-CAPA
Post-CAPA

15. Thank you