Failure investigation report

All information relating to the deviation must be documented in this report:

• description of the deviation,
• root causes found and conclusion,
• results of corrections
• results of additional investigations
• further corrective and preventive actions

This information at the very least is required for the assessment of the suitability of a batch for release. Concluding the additional defined actions and evaluating the effectiveness are not prerequisites for the decision on release.
The goal is to present the chronology of the events and investigations as well as the relationships, risks and actions in such a way that data, assessments and concluding statements can be clearly understood and followed both on a short-term basis (for instance by the Qualified Person in making a release decision) and on a long-term basis (in the event of claims or inspections at a later date). For this purpose, it may be helpful to provide the person performing these tasks with a summary of the basic questions, especially if this goal has to be taken into consideration at an early stage, such as during the examination phase, or when reports are being prepared. The next chapter "Instructions for investigating deviations" provides an example of a work aid of this type.
To encourage a prompt investigation of the deviation a deadline (such as within 30 days) should be set for completion of the failure investigation report. In purely paper-based systems, it is advisable to assign the failure investigation report to the batch documentation, to guarantee that it is also considered for the decision on the release. Other controlled workflows that lead to the same result are also possible in electronic systems.
To ensure unequivocal identification it is helpful to number the failure investigation report, thus also numbering the deviations. For example, pre-numbered forms can be used or a unique numbering system can be created for this. These numbers should be referred to at a specific place in the investigation reports or batch-processing reports.
Figure 1.E-11 shows an example.

Figure 1.E-11

Instructions for investigating deviations

Description of problem

Describe the event and the requirements that were not met. Document all information for clear identification, such as material number, batch number, inventory number, process description, room number, materials affected, intermediate products, test results, etc. Attach photos, drawings, etc. for clarification, if possible.

The following questions should be answered to help in the continued investigation:

• Scope of the problem
  • What happened?
  • What should have happened?
  • What type of problem is involved?
  • What is known about it?
  • What was produced parallel to this?
  • What exactly has been impacted?
• Occurrence of the problem
  • Where did it occur (building, department, room, etc.)?
  • At what stage in the process did it occur?
  • When did it occur (day, time, shift, etc.)?
• Persons involved
  • Who was directly involved (department, shift, employee)?
  • Who else was indirectly involved?
• Extent
  • What proportion of the material is affected?
  • What has been done with this proportion?
  • Could this problem have also occurred elsewhere?
  • What other materials, products, processes and equipment could also be affected?

Summary and conclusion

Summarise the steps of the investigation and present the conclusions drawn from the information gathered for the root cause investigation.

Please answer the following questions:

• What happened?
• Why did it happen?
• What has been determined as the root cause?
• How has this affected the materials or products?
• What corrections have been made?
• What has been done to prevent a recurrence?

Impact

Describe the impact of the deviation and its significance and risks for materials and products for similar or related production runs, products, batches, lots, rooms, equipment, and, where applicable, the steps taken. Explain the reason for such an impact. List all materials and products that may be affected. If the possibility exists that this event could also occur in other units, then the CAPA actions should take this into account.

Please answer the following questions:

• How and with what degree of risk have materials/products (material/batch number) been affected by the root cause of the deficiency?
• What other materials, products, equipment, rooms, etc. have been taken into consideration and why? Why can other materials, etc. be ruled out?
• What happens with the affected quantity?
• Are other products or batches affected that have possibly already been released or are already on the market?

Data history

If necessary, take the existing historical data on validation, deviations, OOS or claims into consideration.

Please answer the following questions:

• Has this deviation occurred before?
• Do comparable complaints exist?
• Are there trends in the OOS results?
• What is the relationship between the observed data and the data and limits of the validation?
• Do comparable cases exist in the CAPA system?
• If so, have the CAPA actions already been completely implemented? Why were they not effective?
• Are the CAPA actions still active? If not, why not?

Failure investigation

Describe in chronological order the steps taken within the scope of the failure investigation and the information obtained for the root cause analysis. Wherever necessary, take the following into consideration when searching for root causes:

• Machines
  • equipment
  • measuring instruments
  • aids
  • maintenance and calibration history
• Personnel
  • directly and indirectly involved employees
  • training status
  • health status
• Materials
  • starting materials
  • media
  • packaging materials
  • trends, anomalies
• Environment
  • temperature, humidity, pressure differences
  • monitoring data
• Processes
  • production processes, testing procedures
  • specifications
  • SOPs
  • statistical process characteristics

Root causes

Consider the following for the root causes determined:

• What is the exact root cause? Are there other and/or deeper-seated causes?
• How can this cause be identified?
• What proof is there of this?
• Is there a justification?

If no clear root cause has been assigned, a probable cause must be determined. Appropriate grounds for this must be given. At least one of the following points is required to substantiate the root cause of the failure:

• observations recorded in the process
• documents from the unit, such as reports
• replication of the failure under comparable conditions

Corrections

Describe the actions necessary to eliminate the existing deviation. The responsible persons doing this should present the following information (as far as necessary):

• How will the correction eliminate the deviation?
• Who will do this?
• When will this take place?
• Are aspects of approval affected by this?
• Has the correction been concluded? What proof is there of this?
• What happens to the materials and products?

Corrective actions

Describe the actions necessary to eliminate the root causes of the existing deviation and to prevent its recurrence. Target data and responsibilities for the implementation must be defined.

In doing so, the following questions should be taken into consideration:

• How is the recurrence of the deviation to be prevented?
• Are multiple corrective actions necessary?
• When are the corrective actions to be implemented and under whose supervision?
• Are aspects of approval affected by this?
• Is it possible that other processes or methods are being affected?
• Do aspects of risk management have to be adapted?
• What proof of complete implementation is necessary?
• How should the effectiveness of the corrective actions be checked?

Preventive actions

Describe the actions that are necessary to avoid possible deviations or trends. Target data and responsibilities for the implementation must be defined.

In doing so, the following questions should be taken into consideration:

• Are other sites, units, rooms, lines, equipment or processes at risk for similar deviations?
• Are aspects of approval affected by this?
• When are the preventive actions to be implemented and under whose supervision?
• Are multiple preventive actions necessary?
• Is it possible that other processes or methods are being affected?
• Do aspects of risk management have to be adapted?
• What proof of complete implementation is necessary?
• How should the effectiveness of the corrective actions be checked?