IA

Impact Assessment analyses (IA) are performed routinely during Good Manufacturing Practice (GMP) of pharmaceuticals and vaccine productions. In the GMP world IA is the process of evaluating impact on product quality based on new or changes in equipment, components, facilities, process, and/or systems. The goal is to ensure that the product is safe for the end user, and that validation efforts and resources are used intelligently and efficiently where they matter most.

Impact assessment can with equal benefits and value be used in the biological and chemical risk management field. Instead of assessing systems and equipment with product quality in mind, we can assess the systems with containment, safety and security aspects in mind.

IMPACT ASSESSMENT FOR CONTAINMENT AND SECURITY

Systems can be categorized with the following 6 aspects in mind.

Impact assessment can help prioritize the focus by identifying what systems are critical for the functionality of the facility

What we want to ensure is that the critical systems are working according to the intent. That we truly can trust these very important engineering systems and controls. By performing an IA we can direct the resources and effort towards the systems that will be the biggest risk if not maintained correctly.

If you have not yet developed an IA for your vital pieces of equipment and utility systems in your company, Vipsit can help you getting started with templates and methodologies.

An IA is a risk assessment and prioritization tool of risk assessments, sorting the systems and prioritizing where the maintenance and documentation effort should be concentrated. It will help you in your dialogue with regulatory authorities, and when budgeting for maintenance.

MAINTENANCE STRATEGIES

The performance indicators (PIs) identified in an IA are the measurable numbers you will keep a trend log of. It will also help you decide on what type of maintenance strategy you will gain most out of:

  • REACTIVE MAINTENANCE: Run it til it breaks
  • PREVENTATIVE MAINTENANCE: Actions based on a time or machine based schedule
  • PREDICATIVE MAINTENANCE: uses PI’s to detect the onset of degradation

Depending on the systems, most facilities/companies will benefit of a mixture of above mentioned strategies; however this can be difficult to explain and defend for regulatory bodies in charge of issuing new operational authorizations. On the other hand if you can explain, defend and document that there is logic to the strategy and approach, most often inspectors will buy the rationales and accept the strategy.