Deviation Management
Deviation management is a systematic process for identifying, investigation and correcting issues that arise when products don’t meet standards. It’s used in manufacturing, quality assurance to ensure compliance with regulations and maintain product quality.
THE DIFFERENCE BETWEEN A DEVIATION AND CAPA
A ‘deviation’ refers to any instance where a process or product deviates from established standards and procedures, or an unexpected variation. CAPA Management is a systematic process used to identify, investigate and address the root cause of the deviation to prevent its recurrence. CAPA is the action plan taken in response to a deviation. These two QMS are linked, however CAPA action plans may be generated without a ‘deviation’ occurring.
TYPES OF DEVIATIONS
Planned Deviations refer to pre-approved and intentional deviations from standard procedures or processes. These deviations are planned and justified in advance, serving various purposes, such as process improvement, method validation, and temporary process changes.
Unplanned Deviations refer to a departure from approved procedures without prior notice or intention. Various factors, such as equipment malfunction, employee error, environmental events, or others, can cause them. Unplanned deviations can significantly impact product quality and safety, and such deviations should be investigated promptly to identify the root cause and prevent them from happening again.
Nonconformity is the nonfulfillment of a specified requirement.
STEPS IN DEVIATION MANAGEMENT
- Identify the deviation
- Document the deviation
- Investigate the deviation
- Determine the cause of the deviation
- Correct the deviation
- Take action to prevent similar deviations from occurring
DEVIATION MANAGEMENT SOFTWARE
Deviation management system software plays a critical role in streamlining the deviation management process. By automating many of the manual tasks involved in deviation management, the software can help companies identify, report, investigate, document, and resolve deviations more quickly and effectively.
LINKS
FDA
- 21 CFR Part 211, Subpart B – Organization and Personnel, 211.22 Responsibilities of quality control unit.
- 21 CFR Part 211, Subpart F – Production and Process Controls, 211.100 Written Procedures; deviations.
- 21 CFR Part 211, Subpart J – Records and Reports, 211.192 Production record review.
- 21 CFR Part 211, Subpart J – Records and Reports, 211.194 Laboratory records.
- 21 CFR Part 820, Subpart G – Production and Process Controls, 820.70 Production and process controls.
- 21 CFR Part 820, Subpart I – Nonconforming Product