A risk-based approach to maintenance is not used It’s common to treat every piece of equipment within a pharma plant equally when it comes to maintenance. A better way is to use a risk-based approach that classifies each piece of equipment in terms of its impact on product quality. We recommend a simple four-category system for equipment:
Direct Impact (Product Critical Equipment)
Any equipment whose failure may directly impact or affect product quality
For example: a mixing vessel
Indirect Impact (Process / System Critical Equipment)
Equipment whose failure may indirectly affect process or system performance,
thus affecting final product quality or safety
For example: the temperature monitor in an autoclave
No Impact Equipment
Equipment whose failure will not impact final product quality, safety or the
For example: the security boom gate at the site entrance
Safety/Environmental Impact System
Equipment whose failure may directly affect safety or the environment.
For example: a boiler
This categorisation system is detailed in the ISPE Baseline Guideline on Qualification and Commissioning, Volume 5, Impact Assessment. The Direct, Indirect, No Impact and Safety categories are sometimes referred to as the D.I.N.S. system.
Using a risk-based approach such as DINS can dramatically impact the amount of work facing a maintenance department. For example, your maintenance schedule may require that all temperature transmitters be calibrated annually. This is the same frequency for an autoclave as for the ambient air temperature measurement in a warehouse. Which one is more likely to impact product quality? The frequency of calibration should be determined during the validation or re-validation project phases. Using the risk-based categorization approach, the temperature transmitter in the autoclave may need calibration every three months, but the warehouse temperature transmitter may need calibration only once every two years.
Computerized Maintenance Management Systems (CMMS) are not utilised, are under utilised or are not validated
A CMMS typically performs five GMP-critical tasks:
Allocating a Unique Identifying Number (UINs) to each piece of equipment
Describing the validated plant configuration
Being the repository of maintenance plans
Holding records of maintenance activities
Scheduling maintenance activities
As consultants to the industry, we often see hybrid management systems within maintenance departments.
These hybrid systems may keep the UIN list in a spreadsheet, store the plans and records as paper files and schedule maintenance activities with a computer system.
Whenever a hybrid system exists, the computer system gets preference because it’s easier. Paper systems are neglected and maintenance job sheets get lost. An auditor will target this area because it’s often difficult for companies to get right. Our advice? Use a validated CMMS system.
Validation should be included in the budget for any CMMS. When using a risk-based approach to validation, you need validate only the five GMP-critical tasks listed above – not the whole system. An unvalidated CMMS is not defendable during an audit, so if you can’t afford validation you may as well forget the whole thing.