08.11.2016 |

LOGFILE No. 41/2016 – The qualification life cycle concept and tools: an overview

The qualification life cycle concept and tools: an overview

An excerpt from the GMP MANUAL

by Ulrike Reuter

The life cycle of a piece of equipment begins with its initial qualification and extends through its time of usage in operation until it is decommissioned.

During usage the qualified status is permanently influenced by external factors. These include planned changes as well as influences during daily usage, such as deviations and wear. Opposed to this is the quality system which monitors and controls the qualification status. This comprises the change and deviation management systems as well as recurring maintenance. The coaction of these factors is presented symbolically in Figure 1.

Figure 1 Life cycle influences

In the following, the tools for maintenance of the qualified status are explained in further detail.

Equipment documentation

When establishing the complete documentation of the life cycle it should be kept in mind that the documentation will get more and more complex over time (see Figure 2). Qualification and operation become more intermeshed with usage and therefore a common filing system and documentation standards should be established.

Figure 2 Growing complexity of documentation

As the documentation must be updated with each change, an overall concept should be established to keep track of all the elements.

One possible alternative is an object-oriented documentation. This orientation should already be initiated at the project planning and execution phases. Object-oriented documentation requires that individual objects be established with strict discipline. This way changes (e.g. the replacement of parts) can be integrated in the documentation more easily.

This topic is usually well managed for safety relevant equipment parts. A safety valve is typically set up in the documentation during the planning phase as a mandatory component. The user requirements and the design specifications are linked with this mandatory part. The valve which is ordered and its certificates and inspection papers are coupled with the specific valve. The real existing valve (actual object) has its own history so that the operator can recognize which valve is currently installed and when it was inspected. This can also be applied to interchangeable fittings.

Risk of failure

As a piece of equipment ages, the probability of a failure tends to increase. Therefore it makes sense to describe and to analyze the risk of failure in a risk analysis. This type of risk analysis assesses the critical parts and their availability, the supply from various media and utilities, other events (fire, earthquake) as well as the sourcing of raw materials or packing materials.


During maintenance it is important to ensure that breakdown analyses are used to improve processes. Maintenance includes the areas of inspection, recurring maintenance and overhauling. Regular planned maintenance also covers the area of calibration. It should be checked regularly whether the maintenance intervals are properly selected. This should be used to detect trends and reflect these in the maintenance strategy. Logbooks, maintenance reports, calibration protocols, calibration deviations and equipment damage can be included as resources. Regularly recurring deviations should receive special attention and appropriate corrective actions should be initiated.

Exchanging like-for-like parts

The exchange of parts with identical replacements (like-for-like) may not be included as part of a formal Change Control process. The term identical parts can include individual pieces, valves or even identical pumps. An example of this might be connecting rod packing glands, electric motors, membranes or seals. Even if the parts are identical the replacement of these parts or components should be documented in the equipment log book, since these may be required for failure analyses or maintenance strategy development, e.g. for the planning of calibration or membrane replacement frequencies. Furthermore, the equipment documentation should be updated, since new material certificates must be filed, e.g. for metallic parts. The release for usage in operations is required. The status of the equipment should be posted. Keeping the documentation up to date is a requirement of Good Engineering Practice (GEP).

Figure 3 provides an example for testing after exchanging a valve (like-for-like) in a pipeline.

Figure 3 Check items for exchange of valves (like-for-like)

The text is an excerpt from the GMP MANUAL.


Ulrike Reuter
Sanofi-Aventis Deutschland GmbH, Frankfurt