Equipment and instruments touch every aspect of a product throughout the manufacturing process. These assets are a critical component of determining the quality of the product in each stage of the manufacturing process, from raw ingredients to final form, including packaging and shipping.
In addition, assets are capital intense to purchase and maintain over time. No matter the industry, facilities constantly need to increase the utilization and uptime of their assets in order to drive the highest return on investment. However, for Life Sciences manufacturers in particular, operational compliance is critical, and the risk of non-compliance in this area can completely cancel out the potential for realizing any measurable ROI.
High Visibility. High Risk.
When it comes to compliance, equipment and instruments are the most highly visible assets to inspectors and investigators. In fact, the equipment is often seen first during an inspection. An auditor will record the asset number and review its history later on. Throughout the inspection, equipment and instruments remain highly visible. If there is an issue with these assets, rest assured, it will be seen challenged, and/or cited.
Here are some of the common examples of the type of compliance risks that assets can pose:
- Risk of operating outside of a validated state
- Lack of controlled inventory of equipment
- Past due or missed calibration or preventive maintenance
- Lack of proper follow up on an out of tolerance calibration
- Lack of proper control of spare parts
- Lack of proposer follow up on cleaning/sterility issues
A failure to adequately manage assets can elevate any of these risks and lead to costly results ranging from FDA observations to product recalls.
By consolidating maintenance and calibration in a single, purpose-built application, companies are able to better manage compliance risks.
Most purpose-built GMP Asset Management systems come with out-of-the-box functionality that provides immediate benefits that drive productivity, while also providing necessary tools to manage compliance. These include built-in support for such basic core requirements as:
- customizable workflows
- electronic signature (21 CFR Part 11) functionality
- an audit trail of all changes made to an asset, work order, or another record stored in the system
- validation and access to vendor support for re-validation efforts and minor configuration changes as needed
Compliance Support Spanning the Equipment Lifecycle
We have seen that there are plenty of potential compliance risks throughout the entire equipment lifecycle, from induction to retirement. A truly effective compliance asset management system can support a manufacturer’s ongoing compliance across the lifecycle with these functions:
- Paperless /Mobile – Compliance risks are greatly reduced by going paperless and utilizing mobile devices. This is because data entry is streamlined. Technicians are no longer hand writing details on work orders and then typing them into the system at a later time. Safety checks are in place to catch mistyped data and alert the technician of potential mistakes. The technician can provide an immediate e-signature verifying that the work order is completed and transition it to a review state to be approved. Paperless and mobile devices reduce errors, prevent lost work orders, and ensure that everything is completed and approved in a timely manner.
Reporting – Reporting can help to identify key trends across entire facilities and on an individual equipment basis. While these trends help to improve quality and manage compliance risks, they also aid in balancing investment so that companies improve product quality while ensuring adequate ROI. Examples of typical equipment analysis metrics, trending reports, and KPIs include:
- Mean Time Between Failure (MTBF)
- Planned vs. Unplanned Work
- Overall Bad Actor Rating – which weights unplanned work, failed calibrations, usage, and cost overages
- Past Due Work
- Calibration Interval Analysis
- Lifecycle Cost Analysis
- Average Time ‘In Progress’ for Maintenance. Calibration and Validation Work
- Time to Complete Work Orders
- Trending Asset Failures
- Asset Maintenance and Calibration Cost Trending
- Nonconformance Workflows – In the event that a calibration fails, the Asset Management solution needs to immediately trigger a nonconformance report (NCR) and alert the proper department to follow up with the NCR. Management can clearly and easily review NCRs making sure they are completed.
- Change Control – The ability to track change controls is vital in managing compliance risks. Asset Management software will record sign-offs and store details of the change request.
- Like-for-Like Parts – An Asset Management solution will track and manage like-for-like spare parts so that technicians are not undergoing a change request each time they are required to replace a ‘low-risk’ part.
- Global Solution and Integration – Another key component in managing compliance risks with an Asset Management solution is the standardization of maintenance and calibration across an organization. The FDA wants to see consistency across all facilities. By using a purpose-built Asset Management application globally, companies will not only satisfy the FDA, but also will drive quality manufacturing. Siloed facilities are eliminated, which increases sharing, learning, and process consistency across facilities/manager. In addition to using a multi-site Asset Management system, it is also vital to integrate with other applications such as MES, LIMS, ERPs, etc., to improve compliance.
The Right Asset Management Solution
With the FDA’s drive for quality manufacturing, companies in the Life Sciences industry should utilize best-in-class maintenance and calibration software to manage compliance risks. The cost of non-compliance can be significant, and also unpredictable. This leaves GMP manufacturers with the constant challenge of balancing reasonable investment with compliance. Purpose-built Asset Management software will satisfy this balance by providing the necessary functionality to both manage compliance risks and drive productivity.