Addparts 创始人 Tom Fripp 谈数字备件管理如何弥补预测性与预防性维护的恢复缺口

Tom Fripp, founder and managing director of Addparts, discusses the limitations of conventional predictive and preventative maintenance, and how digital spares management, supported by controlled digital records and pre-agreed recovery routes, can help manufacturers build greater readiness and respond more effectively to equipment failure.

A resilient pharmaceutical production process is defined by how quickly operations can recover when something goes wrong. When a critical part fails, the immediate result is often unplanned downtime, with production schedules disrupted and labour left underused. But the impact can extend further, affecting other parts of the operation and creating more serious consequences than lost production time alone. A disruption may affect the sterility or general condition of sensitive materials, raising the risk of product variability and perhaps even batch loss.

The full impact of downtime in pharmaceutical manufacturing

Pharmaceutical manufacturers devote extensive time and resources toward mitigating the impact of manufacturing disruptions. When you consider the full impact of even the shortest period of downtime, the reason for this becomes abundantly clear.

Around 42% of unplanned downtime is attributed to equipment failure. When a stoppage occurs, it has an immediate impact on tight production schedules all along the supply chain. A manufacturer may respond by compressing production schedules and running subsequent lines at maximum capacity. Temporary workarounds may also be put in place to reduce the gap in schedules, which could affect material stability and increase GMP compliance risk.

Unplanned downtime also tends to trigger investigations, which can lead to further delays and divert expert team members from other tasks.

Why predictive and preventative maintenance cannot protect production alone

Companies are now increasingly implementing systems which enable them to analyse the performance of equipment in real-time, and predict when a failure may be about to occur.

These systems take account of factors such as temperature, vibration and pressure, and provide insights based on the analysis of patterns in real-time data.

These insights typically feed into a computerised maintenance management system (CMMS), which schedules the work, logs the failure and raises the work order. Between them, the two systems tell a site what is failing and when. Neither holds the part, or the information needed to make one.

Unfortunately, this method of predictive maintenance does not offer adequate protection on its own, due to the realities of sourcing and supplying replacement parts. When a part fails, a company usually approaches the original equipment manufacturer (OEM) for a replacement. Depending on the part required, it may take between two and 20 weeks to receive a replacement from the original equipment manufacturer (OEM). In some cases, the company may discover that the OEM no longer supplies certain parts, since the model in question has been deemed obsolete and is no longer serviced. If a predictive system gives a manufacturer six weeks' warning that a component is likely to fail, but the replacement has a 12-week lead time, the manufacturer still faces a significant exposure window. Even if the replacement is ordered immediately, the equipment may need to operate with the deteriorating component for six weeks, followed by a further six weeks of downtime if it fails as predicted before the replacement arrives.

An obvious reaction to this is to adopt preventative maintenance measures. This involves identifying the parts that are most production-critical and holding replacements in stock. Equipment can also be made subject to regular maintenance and repair, and potentially replaced after a predetermined period of use.

However, every spare part held in reserve is working capital sitting idle in storage, and the sums involved are significant. A 2023 survey by ERIKS and the Institution of Engineering and Technology found that two-thirds of UK manufacturers hold more than £250,000 in maintenance stock, and one in five hold more than £1 million. Much of it never earns its keep: the same survey put the average annual stock write-off at £75,000 per business, while a 2026 survey of 362 manufacturing executives found that 18% of spare parts inventory is still unused five years after purchase.

Closing the gap with digital spares management Predictive maintenance, the CMMS and preventative stockholding all have their benefits, but none can fully close the gap between identifying a potential component failure and having a viable replacement available. Digital spares management helps address this gap by establishing controlled digital records and pre-agreed recovery routes for priority components, reducing reliance on traditional OEM supply pathways. This approach can be built around three practical steps:

1. Identify and document critical components Prioritise equipment and components based on process criticality, equipment age and the potential impact on batch value. Capture the specifications of these priority components in a digital format to establish a foundation for proactive recovery planning.
2. Build a complete picture of each part Document factors such as material suitability, traceability and the potential impact of a breakdown on the wider process.
3. Establish a controlled digital record Store each priority component's specifications, material requirements, supporting documentation and technical information in a controlled digital record, providing a reliable reference for future replacement and recovery decisions.

When a part breaks, manufacturers are able to create a replacement on-demand from this digital record, either as a continuity spare or a precision CNC part. This reduces the dependence on OEM supply, since the part can be built from precise specifications on a far shorter timescale. A digital record is also a far less capital-intensive alternative to traditional stockholding, and can be used to deliver replacement parts for components which are not supported by OEMs.

Crucially, this data repository also includes a roadmap that establishes a clear recovery route in the event of a parts failure. This gives teams immediate access to the material requirements and approval routes needed to source or create replacements. In addition, this data can be updated continuously with the most up-to-date information on equipment age, supplier availability and production priorities.

Assessing the value of a digital spares management strategy

When gauging the value of any new technology or process, it is important to compare it rigorously against existing approaches. Digital spares management strategies can deliver greater production continuity based on a number of measurable metrics, including:

• Mean time to repair (MTTR): This measures the average time required to restore equipment following a failure. Comparing recovery times against conventional OEM replacement routes can help manufacturers assess potential reductions in downtime and the operational value of improved component availability.
• Reducing stored replacements: By storing digital records, companies can reduce stored physical stock and the working capital spent on spare parts, particularly those unused for a year or more.
• More complete documentation: Digital spares management encourages the collection of comprehensive information about each part, including its properties, role and technical requirements. This can support GMP compliance by improving traceability and providing clearer documentation to inform replacement decisions.
• Clearer decision-making: If a company agrees on an appropriate response in advance and documents it within a controlled digital record, this can significantly reduce the time from failure to decision. It also preserves vital engineering knowledge in an accessible format, rather than relying on paper files or individual experts across distributed sites.

The impact of digital production continuity

Production continuity will become an even more integral part of a company’s risk management strategy in future, as manufacturers manage issues such as supply chain uncertainty, product availability and pressures on production efficiency.

Digital spares management provides another layer of resilience by establishing recovery pathways before equipment failure occurs. Maintaining controlled digital records for critical components gives manufacturers access to the specifications, supporting documentation and pre-agreed approval routes needed to respond effectively. This approach also helps preserve engineering knowledge across teams, supporting faster, more informed decisions when disruption occurs.

Prediction tells a site what is about to fail. Readiness decides how quickly it recovers. Predictive maintenance and traditional stockholding both have their place, but establishing clear recovery pathways in advance is what helps close the costly gap between breakdown and recovery. By making digital spares management part of wider continuity planning, manufacturers can move beyond reacting to equipment failure towards being prepared for it.