Managing Risk: GMPs are not Enough

Risk-based asset management offers a way to prioritize assets and reduce overall risk

By Mike Poland, CMRP, Life Cycle Engineering

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Risk-based asset management (RBAM) is a method of implementing an asset-management strategy based on the asset-related risks to the value stream. Good Manufacturing Practices (GMPs) cover all aspects of the manufacturing process including validated steps used in creating product, facilities, transportation and storage of product along with the required training and quality programs documented in standard operating procedures. Finally, to close the plan, do – check – act loop, GMP specifies the requirement for traceability, record keeping and the ability to recall and investigate deficiencies and complaints. Both RBAM and GMP are needed to ensure that all risks are identified and evaluated based on their impact to the value stream.

RBAM is a logical way to visualize the assets’ contribution to the process flow, create the proper taxonomy, prioritize assets, evaluate risk, develop risk controls and then measure the effectiveness of these controls.

Figure 1 Risk-based Asset Management Implementation Model

Classify
The first step in implementing the Risk-based Asset Management model is to develop the process flow diagram for manufacturing the product. An example of a process flow diagram for manufacturing blood vaccines can be found in Chapter 45 of the Food and Drug Administration’s Compliance Program Guidance Manual, “Biological Drug Products.” This allows us to visualize the manufacturing process such as with the process flow diagram in Figure 2.

Figure 2 Process Flow Diagram

Once the process flow diagram has been developed for various products, a value stream map can be developed by adding the quantity of operators, material flow, information flow and general icons. An example of the material flow information would be the data box under each process that contains information about manufacturing the product, like flow time and percent yield. Flow time would be a combination of manual time, auto time and change over.

Figure 3    From the example in Figure 3, aseptic filling takes 3.25 hours. For this product line, this batch process is designed to fill 10,000 5cc vials in 3.25 hours. This is at a rate of one vial every 1.17 seconds. In a liquid fill, this process is also the constraint. These parameters are important when we get to the final phase of our implementation model, “Measure”, because we need to document the designed or best demonstrated rates of our process to trend performance and use in loss elimination and continuous improvement activities. Transparency in these measures is also important because we can use them in our visual management system.

Once the process flow diagram is complete, we can model the process by assigning the equipment that is utilized in the process and the relationship with distributive systems such as electrical power and steam supply. Reliability block diagrams also allow the process or system to be modeled to identify single point failures and redundancy. Once the modeling is complete, asset types must be defined to ensure assets with like attributes are known in order to streamline analysis. A corporate policy on naming and description conventions should be developed so that an autoclave in one process or facility is specified the same way and at the same level of the hierarchy as the next.

Hierarchy development is the final component and one that is rarely done correctly. Most organizations’ hierarchical structures were developed when their financial accounting software was implemented. These structures are more aligned to general ledger and balance sheets linking to cost centers, not to the lowest level of maintainable component, which is considered best practice from an asset management perspective. Figure 4 below is an excerpt from ISO 14224:2006, Petroleum, petrochemical and natural gas industries – Collection and exchange of reliability and maintenance data for equipment. Even though this international standard is not specifically designed for the pharmaceutical industry, a significant amount of this information is relevant.

Figure 4 Collection and exchange of reliability and maintenance data for equipment

Most organizations make the mistake of developing their hierarchy to level 4 or 5 instead of level 7, so work orders are written to the system or process level and material is also mapped to that location. This makes identifying repair parts or evaluating bad actors almost impossible. Instrumentation and control is usually another weakness in the way the hierarchical structure is developed. If there are door switches and pressure instruments that require calibration for an autoclave, do they show up as children to the autoclave or is their parent the room in which they are located? The latter is typical due to the way the calibration program is set up, but provides significant risk in aligning critical instrumentation to the equipment which it serves.

Analyze
The next phase of risk-based asset management is to analyze the assets and develop a prioritization of how those assets impact the value stream and how corporate resources will be allocated. This is a significant component of the RBAM methodology because identifying risk, and then developing control strategies to mitigate or eliminate it, are the keys to success.

Performing a criticality analysis on the equipment seems like a daunting task, but without it, how can prioritization occur? A good understanding of the value that the products create, and which processes are required to manufacture them, is an important first step. From there, you can evaluate the equipment on impact to the value stream by looking at how failures to that equipment will impact environment, health, safety, reputation and production. Then you develop a scale from 1 to 10, rate the equipment against these variables, and then calculate the overall criticality of the equipment. Figure 5 is an example of what the criticality analysis would look like.

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