Posted on: 28th June 2017

The Drug Substance (DS) reliability workstream has developed guidance enabling member companies to optimize their maintenance and calibration frequencies by assigning the correct ‘trigger’ for these activities. The guidance describes the various tools and processes available, as well as methods to implement change, illustrated by case studies. The Return on Investment (RoI) for optimization of maintenance frequencies is clear: direct reduction of maintenance man-hours and planned downtime, thus increasing plant availability. This translates to financial savings as well as increased production capacity.

The guidance document can be accessed here:

Currently, significant time and resource is expended on planned maintenance and calibration activities that add no value, do not increase asset reliability and can even have a detrimental affect to productivity by directly causing equipment failure. These frequencies aren’t driven by data or scientific basis and generally are assigned because historically ‘they have always been executed that way’. How often have you seen a planned maintenance (PM) or calibration task scheduled yearly as standard, and everyone from Engineering, QA, regulators to production are comfortable with that? However, the only reason for assigning a yearly frequency is because the earth has rotated around the sun once – there really is no more supporting data or science to it than that.

Vendors may recommend a specific frequency, but generally will ‘play it safe’ and may be led by the vendors’ driver to increase sales for change parts. – Remember, they have no understanding of the operational environment the equipment will be used in. Would you change the tyres on your car on a yearly frequency regardless of whether it had done 5,000 or 50,000 miles in that year? Or would you review data such as wear and tread depth before you invested in new tyres?

Intrusive maintenance activities can actually cause failures. How often have you come out of a shutdown and equipment has failed to start-up due to the routine maintenance that has taken place? Or an instrument has been damaged during a calibration routine? A less frequent intervention will reduce this risk.

The guidance outlines methods to assess equipment and put in place the right PM at the right time, using a data driven approach.

Why it’s important to implement and optimize your maintenance frequencies

As the case studies in the guidance demonstrate there are significant gains to be made by optimizing maintenance and calibration frequencies and the consequential reduction in labor hours – not just from the direct cost savings from a maintenance team’s perspective but to all stakeholders. The resulting increase in plant availability (both from planned shutdowns and unplanned downtime) is something that all areas of a biopharma organization will gain from, as it directly improves capacity to produce batches and thus impacts the bottom line.

So many organizations have not yet challenged their maintenance or calibration frequencies, it is ‘low hanging fruit’ that can be targeted to gain huge returns in terms of dollars but also product quality. By introducing the right task at the right time, a risk based approach reduces risk to equipment and thus product.

One case study particularly illustrates the use of statistical methods to analyse historical failure data and assign the correct frequency to calibration activities. It shows how one organization could reduce calibrations by over 50% across its operations, resulting in direct savings in the region of $1-$2m year on year.

What we are going to do as a reliability ‘COP’?

Although the reliability workstream has now transitioned to a Community of Practice (COP), work will not stop. A key focus of the COP will be to track implementation of this guidance and to support member companies by sharing case studies and lessons learnt to identify improvement opportunities.

What companies need to do?

Each company can make changes to calibration and maintenance routines and realize the benefits that are there to be gained.

L3s within the reliability COP will be connecting with key stakeholders in their organizations to begin implementation. Clearly, these stakeholders need to understand and endorse the changes that will be proposed (complete with a risk-based justification). Key for this is for senior leadership to provide clear support and guidance to implement changes.

If you are interested in learning more about this process, please reach out to your L3s in the reliability team.

Have Your Say

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.