Pharmaceutical Inspection Co-operation Scheme (PIC/S) recently published risk assessment for on-site inspections: “COVID-19 RISK ASSESSMENT FOR NATIONAL ROUTINE ON-SITE INSPECTIONS.” This article provides an overview of the key topics in PIC/S’s risk assessment. Readers are encouraged to consult the original document and relevant information sources for detailed information.
A risk assessment is a systematic determination of the probability that a hazard will be realized and the severity of the potential consequences. As part of the PIC/S’s inspection planning process, each inspection is assigned a risk rating based on the likelihood of the potential failure mode occurring and the potential consequences of such occurrence. The risk rating is used to determine the number of inspectors required for an inspection, the type of inspection required, and the extent of testing required during the inspection.
The PIC/S has developed a new risk assessment method for on-site inspections of pharmaceutical manufacturers and is planning to roll it out to all inspected companies in the near future. This new method is based on a FMEA (Failure Mode and Effects Analysis), a well-known method in the industry.
Failure Mode and Effects Analysis (FMEA) is a systematic method for analyzing failures in a product or service and planning measures to reduce the risk of occurrence.
A FMEA analysis involves the following steps:
- Identify the possible failures,
- Rate the importance of each failure,
- Measure the risk of occurrence, and
- Evaluate the risk reduction of each possible failure mode.
The primary objective of a PIC/S inspection is the verification of the safety integrity level of the plant and to ensure that the plant operates in accordance with the requirements of the licenses. The PIC/S risk assessment is based on a FMEA (Failure Modes and Effects Analysis) and should be carried out during the planning phase of the inspection together with the company to be inspected.
Here are the topics discussed in the PIC/S’s risk assessment document:
- Adequate social distancing is necessary for safe inspection. The social distance should be enough to avoid crowded conditions that may be prone to transmission of infection. In order to maintain appropriate social distance, it is best to follow appropriate guidelines.
Safe distance from other persons is important to prevent communicable disease transmission. Inspectors should be mindful of their time on site and their environment, and don’t forget to practice good hygiene.
- There are a few things to think about the inspectors when going into a facility, for example, do they know how to properly decontaminate and disinfect surfaces? Or are they following national/government guidance on how to continue operations?
- The inspector should only take what he needs with him to the inspection, and should wipe down any equipment he has used before leaving. When it is necessary to take objects from the facility, quarantine them for several days or perform specific disinfection procedures. When possible, the inspector should review documents electronically. It is best to stay away from surfaces that are not necessary to the inspection.
- There are many steps to ensuring your safety before, during, and after an inspection. Planning is key, make sure to be aware of local restrictions and lock down measures.
For inspectors, it is not only important to have a thorough understanding of the area they are going to be inspecting, but it is also important to have a thorough understanding of their own health as well.
- A good inspector will inform the site should they test positive for COVID-19.
- Inspectors planning on traveling abroad for an inspection should check the travel advisories for their destination and to abide by any local lockdowns.
- The inspector should be careful to limit their exposure to risk by limiting time in communal areas, limiting interaction with other people, and wearing a face covering to limit exposure.
- Inspectors planning on taking a visit to an inspection, make sure to have the right Personal Protective Equipment (PPE), that the facilities hosting the visit provide adequate PPE, and that you only use your PPE once.
Maintaining appropriate social distance from other persons is important in preventing the transmission of infection. It’s not just about logistics and sanitary conditions, it’s about human behaviour. Inspectors should plan ahead of their inspection and take extra care to protect them and others as well.
Note: This article is provided for information only and not a substitute for the PIC/S risk assessment document. Readers are recommended to consult the original here for risk assessment.
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