The secret of successful decommissioning
Are you already familiar with qualification in life sciences? If so, the term 'V-model' will probably sound familiar. This is because the V-model outlines the steps required to build and qualify a new system from start to finish. These steps include URS, FS, DS, FAT, SAT, commissioning, installation qualification, operational qualification and performance qualification.
Wannes (commissioning & qualification engineer) and Kristof (compliance engineer) worked on a project with the main objective of 'decommissioning'. Sounds rather simple, right? The opposite of commissioning, or is it not so straightforward after all? In this blog, Wannes and Kristof share their experiences with decommissioning and stress its importance.
What is decommissioning?
Deconstructing, taking out of service or dismantling a system? Then we speak of decommissioning. Decommissioning can be compared to a modified V-model. Unlike starting with a URS, decommissioning starts with an already existing system. The URS can be considered the scope of the system to be decommissioned. FS and DS then describe how the system will be decommissioned. Various aspects are considered here.
Important aspects of decommissioning include:
- Documentation: Analysing the documentation of the system and linked systems. This includes procedures, drawings and other relevant information.
- Physical aspects: Planning the physical decommissioning of the system and modifying the linked systems so that they can become operational again.
- Automation and data management: Since many of these systems are controlled automatically (PLCs, HMIs, etc.), it is important to take into account the data kept in monitoring systems. A clear overview of all relevant aspects in scope is essential.
Some key concepts
Installation Qualification (IQ) Iinvolves checking whether documents have actually been modified or are inactive. This seems simple at first glance, but in reality, checking a large number of documents, such as 3,000 procedures and drawings for tearing down a plant, can be a time-consuming task. It is also necessary to ensure that all automation is disabled.
OQ (Operational Qualification) involves verifying that the system has continued to do correct, quality work up to the last day of operation. This includes performing a final calibration, sampling, mapping and so on. Any discrepancies must be analysed and dealt with before the decommissioning process can continue.
PQ (Performance Qualification) does not look at the functioning of the system, but its inactive state or complete deconstruction.
Although decommissioning bears some resemblance to standard validation, there are some important details that need to be considered before starting the full process.
Pitfalls of decommissioning
Decommissioning can involve several pitfalls that require attention. Here are some important details to consider:
- Documentation impact: It is crucial to know in advance which documents will all be affected. Over the years the system has been in use, many documents have been created and procedures from other systems have often been referenced. These references can easily be overlooked and not included in decommissioning. As a result, some documentation may no longer be up-to-date.
- Historical errors: Historical errors may also come to light during the decommissioning process. These are errors in the documentation that do not match the actual situation. They may originate from other projects where documentation was not properly maintained, requiring additional efforts to correct these errors.
- Connected utilities: Decommissioning should also take into account systems that remain in service, such as connected utilities. When a branch of the system is shut down or decommissioned, it is very important that no dead zones are created at these systems. In addition to physical changes, certain documents also need to be updated to ensure that everything continues to function properly.
- 'Laissez faire' mentality: A pitfall with decommissioning is that a 'laissez faire' mentality can quickly develop, as it is "only" about dismantling. Once all GMP-critical issues have been dealt with, such as calibrations, sampling and procedures, there can be a lack of immediate pressure and impact on other systems to complete the remaining issues. This can lead to failure to meet set deadlines.
It is essential to keep these pitfalls in mind and take proactive measures to avoid them during the decommissioning process.
In conclusion
Listening to Wannes and Kristof's experiences, it becomes clear that decommissioning is much more than just tearing down systems. It is a careful process that requires attention to documentation, historical errors, connected utilities and avoiding a 'laissez faire' mentality. Decommissioning may be the opposite of commissioning, but it brings its own challenges.