Interested in linking to "Managing Risk: GMPs Are Not Enough"?
You may use the Headline, Deck, Byline and URL of this article on your Web site. To link to this article, select and copy the HTML code below and paste it on your own Web site.
By Mike Poland, CMRP, Life Cycle Engineering
Risk-based asset management (RBAM) is a method of implementing an asset-management strategy based on the asset-related risks to the value stream. Together with current Good Manufacturing Practices (GMPs), RBAM ensures that all risks are identified and evaluated based on their impact to the value stream.
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, GMPs specify the requirement for traceability, record keeping and the ability to recall and investigate deficiencies and complaints.
Both RBAM and GMPs 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).
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.
Once the process flow diagram has been developed for various products, a value stream map can be developed by adding the number 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, providing process parameters such as flow time and percent yield. Flow time would be a combination of manual time, auto time and changeover (Figure 3).
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 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.
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 approach is typical, due to the way the calibration program is set up, but adds significant risk when aligning critical instrumentation to the equipment which it serves.
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.
PharmaManufacturing.com is the site for knowledge, news and analysis for manufacturing and other professionals working in the pharmaceutical, biopharmaceutical and biotech industries.