Instructions for preparing an inspection response

After the inspection, the inspection report is submitted to the inspected party and a response is requested. The response must include the planned corrective and preventive actions to be taken for the findings and an estimated timetable for their implementation. Depending on the inspection area, the probable root cause of the finding may also be requested. The deadline for submitting a response will also be specified.

Responses that require additional information and/or clarifications demand time from both the inspected party and the inspector and may lead to a prolonged inspection process. The purpose of this informal guideline is to help draft a response that meets the expectations of inspectors and speeds up the completion of the inspection process. 

To whom is the finding addressed?

The person or actor responsible mentioned in the inspection report is the person or actor who is primarily expected to respond to the finding and take responsibility for the necessary action (hereafter referred to as the responsible party). 

Assessment and root cause analysis of the finding

The responsible party should first familiarise themselves with the finding and go through the context and references provided by the inspector. At the very least, the finding relates to the detail and evidence found during the inspection, but it may also be more extensive or systematic. Understanding the finding and its extent is important for a proper starting point for the root cause analysis. If the finding is unclear, the inspector can be asked for further information or clarification.

Once the finding and in particular its extent have been assessed, a root cause analysis can be carried out. The root cause analysis must be sufficiently comprehensive and extensive. For example, "human error" is not a good root cause because it can render the root cause analysis too superficial and prevent the identification of recurrent or systematic causes.  Without a proper root cause analysis, corrective and preventive actions cannot be properly targeted.

Correction and corrective action

A correction is the rectification of an identified finding. A corrective action is an action taken to remedy the cause of a finding, to eliminate the cause of the finding found and to prevent its recurrence.

Depending on the evidence, the root cause analysis and the situation, the finding may require a remedy and/or a corrective action. In some cases, adequate correction and/or corrective action may also include documenting the issue with clarifications, impact assessments and justifications. However, documentation should only be used if the correction and/or corrective action is no longer possible.

Preventive action

A preventive action is a measure aimed at eliminating the cause of a possible finding in the future. In other words, the preventive action prevents a similar finding from occurring in the future within the same quality system (such as in new studies or activities). 

The description of the preventive action should include details of planned changes to the documented systems, procedures and/or processes. Planned changes and/or preventive actions may require training. At this point, it is also worth considering whether there are any methods to assess the effectiveness of the preventive action.

Schedule

The responsible party must provide a schedule of the corrective actions and preventive actions to be taken and the deadline by which they will be implemented. The actions must be implemented as quickly as possible, but the schedule must also be realistic and feasible. If the schedule for implementation is significantly delayed, the inspected party must inform the inspector of the delay.

Efficiency assessment

An efficiency assessment is essential in ensuring that a preventive action has been successful in preventing a similar finding from occurring. Efficiency can be assessed using quantitative (for example, the frequency of errors before and after a preventive action) or qualitative methods. If it is later found that the preventive action has not been effective, the situation should be reviewed to identify and implement new actions.

Possible errors 

If the responsible party considers the finding to be incorrect, the inspected party has the right to issue a statement on it. The error detected must be clearly and accurately described in the statement. Where requested separately, appropriate evidence must be provided to demonstrate the error. The evidence should be, for example, documentation that existed before the inspection. 

Format of the inspection response

The response must contain at least the following information for each finding for which a response has been requested:
 
•    The finding number and any applicable sub-numbers used in the inspection report (if necessary, a single finding can be split into several parts)
•    The result of the assessment and the root cause analysis, if the inspector of the inspection area concerned has requested a root cause analysis.
•    The corrective actions and their schedule (deadline by which the actions must be implemented)
•    The preventive actions and their schedule (deadline by which the actions must be implemented)

Unless otherwise specified in the inspection report, the format of the response is open. An example of a possible format can be found at the end of this guideline. If there is more than one responsible party, responses may be submitted together or separately but must be submitted at the same time. The language can be English by separate agreement. The response must include a traceable version and the name of the party that submitted it (for example, by adding a signature and date).

Inspector's assessment of the response 

After receiving the response, the inspector will assess it and provide feedback on any responses that are not sufficient. If necessary, the inspector may ask for further clarification of the response.  If the response is incomplete, this may lead to a re-inspection or to further action as defined by the applicable legislation on the inspection area concerned.

End of inspection

The inspection is considered complete when the response of the inspection party and any further clarifications have been assessed. Depending on the inspection area, the inspector may also require the inspection party to report the completion of corrective actions and preventive actions before the end of the inspection (this may also be a requirement for the GXP certificate issued by Fimea for the pharmaceutical industry).  
The inspector notifies the inspection party of the end of the inspection. The response and its assessment are documented as part of the final inspection report. The complete report is forwarded to the responsible party for information and/or documented by the inspector for the internal inspection function of Fimea.

An example of a response:

Finding	Finding number (and description) as in the inspection report.
Assessment and root cause	The outcome of the assessment and the defined root cause.
Corrective action(s)	Description of detailed corrective actions.	Deadline	dd.mm.yyyy
Preventive action(s)	Description of detailed preventive actions.	Deadline	dd.mm.yyyy