General Inspection Process
The HPRA shall conduct a regular inspection of each site of a blood or tissue establishment \organ procurement organisations or transplantation centres, as defined in the relevant legislation. Inspections are carried out for the purpose of ensuring:
(a) establishments/organisations/centres comply with the requirements of legislation, and
(b) problems relating to compliance with those requirements are identified.
The HPRA may conduct such additional inspections at establishments/organisations/centres as it considers necessary for the purpose of ensuring compliance with the requirements of legislation.
The Inspection Process
The Inspection Process may be summarised as follows:
- Inspection Organised
- Inspection Carried Out
- Deficiencies against requirements of Regulations and Good Practice Identified
- Report written by Inspectors and sent to establishments/organisations/centres
- Responses (corrective actions) and timeframes submitted to HPRA and Reviewed by Inspectors
- Further Responses Required or Further Inspection Required based on Responses
- Close out of Inspection
Organisation of Inspection
Official Notification will be sent to the Responsible Person up to 6 weeks prior to the Inspection.
The notification shall contain an outline of the Inspection and a list of the documents required for review:
This may include:
- Organisation Chart
- List of all personnel employed in establishments/organisations/centres
- Job Descriptions of Key Personnel
- Training records
- List of SOPs
- List of Deviations/Non-Conformances
- List of Complaints
- List of Recalls
- Validation Master Plan
Normally, the format of the inspection is as follows:
Opening Meeting – Inspection – Closing Meeting
The HPRA advises that relevant management personnel are present at the opening and closing meetings. During the inspection itself, the responsible person, quality manager or nominated individual(s) should be present at all times.
The opening meeting shall be conducted by the Inspector(s)
It gives an opportunity to introduce the inspection team and the participants. Some background information gathering may take place at this stage. The plan for the inspection may be discussed at this stage. The opening meeting also provides an opportunity for the establishment/organisation/centre to present an overview of activities or to update on recent developments. It is also an opportunity for the participants to ask questions prior to the beginning of the inspection.
The actual inspection is about obtaining information. This may be achieved by witnessing tasks being performed, by reviewing documented procedures, by asking questions – Who? What? When? Where? By investigating issues – Why? The inspection should always be performed with open and honest exchange.
The closing meeting shall also be conducted by the inspector. The inspector shall explain the classification of deficiencies and present the findings of the inspection during this meeting.
The deficiencies are classified into the following categories:
A critical deficiency may be defined as a failure which indicates a significant risk that blood/blood components, tissues/cells or organs could or would be harmful to the patient, or a failure which has produced harmful blood/blood components, tissues/cells or organs for transplantation.
A major deficiency may be defined as a non-critical failure which could or would result in blood/blood components, tissues/cells or organs obtained for transplantation that do not comply with the requirements of relevant legislation.
An ‘other’ deficiency may be defined as a failure which cannot be classified as either critical or major, but which indicates a departure from GP. These deficiencies are considered as minor.
Points for clarification / Points to note
The observations might lead to suggestions on how to improve quality or reduce the potential for a non-compliance to occur in the future.
Participants will have an opportunity to provide further information in relation to the findings if required. The inspector(s) shall then inform participants of the next steps in the process i.e. responses required, further inspections etc.
Review of responses
The inspection report should be received within 15 days of the last day of inspection. Responses (corrective actions) and timeframes are required to be received by the HPRA 35 days after the end date of the inspection. The corrective action taken and the proposed timeframes shall be reviewed by the inspector. Further information may be requested. If the responses are satisfactory the inspection shall be closed and the inspector will instruct participants regarding follow up inspections and the next steps in the process.