SOP For incident reporting and investigation is described in this post which you can follow in the section of the Quality Assurance Department.

OBJECTIVE

To lay down the procedure for incident reporting and investigation.

SCOPE

This SOP is applicable to all incidents which can affect the safety, identity, strength, purity and quality of the product with facility, storage, Production, Raw/ Packaging, finished product sampling, testing or release related, Distribution related. Unplanned deviations from approved procedures.

RESPONSIBILITY

QA Officer

ACCOUNTABILITY

Manager Quality Assurance

PROCEDURE

Event: Any unforeseen event.

  • Deviations from approved protocols or standard operating procedures without prior authorization and documentation.
  • Any variance from established specification or requirements stated in quality system document, which includes but not limited to SOP, BMR, PO, that would affect the safety, identity, strength, purity and/or quality of the product.
  • Activity or the operation performed in excess of that defined in a BMR, SOP or other approved documents.

Incident

It is similar to the event but requires extensive investigation if the assignable cause is not identified while event investigation /repetitive event or breakdown of equipment or machine / there is the impact on other batches.

Investigation

  • General process of information or data gathering, analysis & checking possible causes to find out the cause.
  • Repetitive events/ equipment breakdowns
  • Same event occurring in the same product more than once. e.g. less yield in same product batches or different product batches processed on same machine/equipment.
  • Same equipment failure/process parameter out of limit occurring in same equipment more than once. e.g. temperature out of limit during the coating process.
  • The same equipment failure/ process parameter out of limit occurring in different equipment/ machine due to a common utility problem. e.g. cooling zone temperature out of limit in different tunnels.

Corrective Action

  • The term "correction" usually refers to the repair, rework or adjustment made to the product as part of the disposition of an existing nonconformity.
  • A corrective action is action taken to eliminate the causes of an existing non-conformity, defect or other undesirable situation in order to prevent recurrence.
  • Note: There can be more than one cause for a nonconformity. Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent the occurrence.
  • In ISO and other guidance's three terms are used to explain CAPA. i.e. Correction, Corrective action and Preventive action. But for easy understanding, only two terms are used in below examples.

Preventive Action

  • A preventive action is an action taken to eliminate the cause of a potential nonconformity, defect or other undesirable situation in order to prevent its occurrence.
  • Note: There can be more than one cause for a potential nonconformity.
  • Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.
Examples of Corrective action and Preventive action.

  • Incident: Punch breakage while compression of drum no. 5.
  • Cause identified: Wear and tear on the prolonged use of the punches.

Corrective Actions: 

1) Passed the compressed tablets of drum number 5 through the metal detector. 2) Replaced the broken punch with new punch set. 

3) Destroyed the punch set.

Preventive Actions: 

To restrict the use of the toolset up to compression of X million tablets.

Incident: After drying, the yield of lubricated granules found approximately X kg less.

Cause identified: Particle flow sensor of FBD was switched off. The operator was not aware of the importance of the sensor.

Corrective actions: 

1) Qty of lubricants reduced proportionately before lubrication. 

2) Training is given to the concerned.

Preventive action: The particle flow sensor shall be put on during the drying operation and shall be ensured by the supervisor and shall be made as a part of FBD checklist.

Root Cause: The identifiable factors based on objective evidence which have been determined to be responsible for the incident are known as root cause.

Probable Cause: The identifiable factors which is most likely to be responsible for the incidence.