Pharma Industry Interview Question & Answer Part 10 (Risk Assessment)

 

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Question 01:  

Is it acceptable to link quality risk management with cost saving measures?
 

Best Answer: The expectation of QRM is to assess risks to the medicinal product and patient and manage these to an acceptable level. It is appropriate for companies to assess their control systems to implement the optimum controls to ensure product quality and patient safety.

 
If this can be achieved in a more cost effective manner while maintaining or reducing risk to the product and patient then this is acceptable.
 
However inappropriate risk assessment and mitigation in order to achieve cost savings is not appropriate.
 
 
 
Question 02: 

What is the difference between a planned and unplanned risk assessment?

Best Answer: A planned risk assessment is one that is conducted in advance of conducting an activity, either before any activity is conducted or before further activity is conducted.
 
This would often allow quality to be built in to activities and risk reduced (quality by design) eg design of facilities for manufacture of cytotoxic products or organisation/design of a label printing room.
 
An unplanned risk assessment is one that is conducted to assess the impact of a situation that has already occurred, eg impact of a deviation from normal ways of working.
 
 
 
Question 03: 

Are any areas out of bounds for risk assessment?
 
Best Answer: It would be unacceptable for risk assessment to conclude that statutory, regulatory or GMP requirements should not be followed or are not appropriate eg risk assessment could not conclude that it was appropriate for licensed products to be released by someone who was not a qualified person (QP).
 
Otherwise risk assessments can be used within GMP systems as a tool to identify,
quantify and minimize and control risk to patient safety.
 
 
Question 04: 

Do risk assessments have to be supported by factual evidence or can they just use
professional judgment?
 
Best Answer: There should be factual evidence recorded to support any conclusions drawn eg plant design details in controlling cross contamination - an unsupported assumption that the plant must be suitably designed as we have used it for 10 years or we’ve had a standard operating procedure (SOP) for five years so it must be suitable is a weak approach that may be unfounded and must be challenged by those conducting risk assessments.
 
Professional judgment should be used in interpretation of factual evidence but must be subject to justification.
 

Question 05:

How should risk assessments be controlled?

Best Answer: Risk assessments should be controlled within a defined document management system. If risk assessments are conducted to justify controls for an ongoing process then the assessments should be subject to change control and periodic review, eg line clearance risk assessment.
 
Frequency of review should be appropriate for the nature of the process. Such risk assessments should be seen as living documents that are visible and subject to change as and when required.
 
Risk assessments that were conducted as one off activities to assess a situation that will not recur need not be controlled in a ‘live’ manner but must be documented, approved and retained eg assessment of a temperature excursion on storage of a batch of starting material.
 
Such ‘one off’ activities should be controlled as live documents if any conclusions are to be used in any future excursions. Ultimately these may then need to be reviewed in light of experience or developments.
 
 
 
 
 Question 06: 

Is it acceptable to allow external consultants to participate in site risk assessments?

Best Answer: It may be appropriate for consultants to provide support for risk assessments where they can provide specific expertise or knowledge. Their role in the risk assessment should be clear.
 
The reason for delegation and resultant accountability must be understood. Inspectors will expect sites to demonstrate that delegation was effective and that appropriate skill, knowledge, local knowledge and local accountability was appropriate for the life cycle of the risk assessment.

A technical agreement may be appropriate with the consultant where GMP responsibility is assumed.
 
 
 
Question 07 : 

Is it acceptable to allow contract staff to participate in site risk assessments?

Best Answer: It would be usual for contract staff, eg contract QPs to lead or participate in risk assessments. The extent of involvement as responsibility/accountability must be documented in the technical agreement between the individual and the organisation.
 
 
Question 08: 

How do inspectors deal with the risk assessment if a residual risk remains in the review?

Best Answer: ICH Q9 clearly points out that there will always be resi-dual risks. What residual risks are acceptable always depends on their potential influences on patients. Principally the residual risk is not the problem but possibly its level.
 
 
 
Question 09: 

At which phases of the system life-cycle is risk management recommended?

Best Answer: Risk management should be applied throughout the whole life-cycle. A first risk assessment should be performed to determine the GMP criticality of the system, i.e. does the system have an impact on patient safety, product quality or data integrity?

User-requirement specifications are usually developed with consideration of potential risks and form the basis for the first formal risk assessment. Complex systems should be evaluated in further more detailed risk assessments to determine critical functions.

This will help ensure that validation activities cover all critical functions. Risk management includes the implementation of appropriate controls and their verification.
 
 
 Question 10:  

In what way can the URS be created on the basis of a risk analysis if the risk analysis requires an URS as a pre- requisite?

 
Best Answer: URS and risk analysis are two elements within the context of validation of computerised systems which are closely linked with each other.
 
Requirements can result from a risk analysis but on the other hand it is possible to reach functional solutions on the basis of user requirements on the assessment of risks.
 
 
 
 

“Trust but Verify “ Ronald Re

 

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