10common Challenges Facing Maintenance Departments in Pharmaceutical plant

Challenge 1: 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 Environment.
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

Challenge 2: Computerized Maintenance Management Systems (CMMS) are not utilised, are under utilised or are not validated

A CMMS typically performs five GMP-critical tasks:

a) Allocating a Unique Identifying Number (UINs) to each piece of equipment
b) Describing the validated plant configuration
c) Being the repository of maintenance plans
d) Holding records of maintenance activities
e) 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.

Challenge 3: Maintenance plans are not updated as part of new equipment introduction

Buying a new piece of hi-tech machinery is very exciting. All the engineers scramble to be the first one to stroke its gleaming steel. Amongst all that excitement, the fact that this newbie has to be maintained is often neglected. Updating the maintenance plan should be included as an activity in the procedure covering new equipment installation.

Buying a new piece of hi-tech machinery is very exciting All the engineers scramble to be the first one to stroke its gleaming steel.

Challenge 4: Maintenance staff and contractors are not trained properly

Do your maintenance workers and contractors know the impact of changing a setting on a piece of production equipment? Do they understand the concept of a validated state? Do they know when to involve QA?
Let’s face it – maintenance staff would rather watch 15 hours of snail racing on TV than complete paperwork. It’s hard enough to get them to complete maintenance records, let alone Change Control forms. Yet simple maintenance activities such as changing filters or adding lubricant can dramatically impact product quality.
The GMP regulations require all contractors to be trained appropriately before they enter GMP areas. Developing tight, long term relationships with your contracting suppliers is critical. Their HR systems should trigger GMP training for every new hire. You could request that small contracting companies use a simple checklist when a new hire commences work. "GMP training" could be on that checklist.