Using Consensus Standards
The National Technology Transfer and Advancement Act of 1995 requires federal agencies (i.e., EPA, FDA, OSHA, etc.) to recognize existing consensus standards where available and applicable. That means that all government agencies have been instructed to accept the premise of consensus standards and abide by their requirements.
ASTM E2500 describes a science and risk-based evaluation process that is designed to improve how equipment capabilities and performance are validated. The standard achieves its objective by using quality management principles throughout the system life cycle. This approach required incorporating information developed by business owners during the conceptual phase, by the engineering and the equipment supplier during the design phase, and continues through start-up and operation.
ISA88 describes terminology and models that result in good design and operational practices of process facilities. The premise of ISA88 is to create a hierarchy of module classes that carry out a variety of equipment-centric functions. Depending on process requirements, module classes are orchestrated through a hierarchy of procedures and product recipes.
ISA95 describes the terminology and models for the integration between business (i.e., enterprise resources planning [ERP] and manufacturing execution systems [MES]) and process control systems. The standard provides details about structuring information using a standardized exchange format that is recognized by most ERP and MES applications. The ISA95 standard has proven useful for a variety of purposes including serving as a guide for the definition of user requirements, for the selection of MES suppliers and as a basis for the development of MES systems and databases.
Originally ASTM E2500 was developed by the healthcare industry and ISA88 for batch processes. Since then, both have proven applicable to other industry sectors, including continuous processes. Further proof of ISA88’s ability to benefit other industry sectors is demonstrated by its adoption by the Organization for Machine Automation and Control and the subsequent creation of S88.05 for use by the packaging industry.
Traditionally, the approach to getting instrumentation and control components from shipping box to on-line production has been referred to as “commissioning,” and it consists of a string of sequentially executed tasks that frequently begin with on-site activities, thus all but ignoring potential FAT contributions to the process.
Following careful examination and in-depth discussions, BMS engineers were convinced that the combined use of ASTM E2500 and ISA88 provided minimal risk and significant benefits to validating such a highly automated system.
In order for a risk-based process to work, all stakeholders―engineering, quality, maintenance and manufacturing―need to be able to roll up their sleeves and work collaboratively from day one.
Certainly the use of electronic tools facilitates efficient collaboration, but significant efficiency gains are also available through the use of pleasant communal “open office” spaces.
One of Bristol-Myers Squibb’s strategic goals is to advance its “environmental greenness,” and the Deven facility represents a significant commitment toward that goal. Constructed of energy- efficient materials, glass walls and highly efficient heating and electrical systems, Deven’s communal office spaces are flooded with natural light thus creating a pleasant yet efficient working environment.
Long before moving into the new Deven building, project team members initiated their own communal working environment by locating various departmental representatives in close proximity to one another. Amid the benefits of the communal project team environment was a recognition that eventually became one of the projects guiding principles: “Get the right data, at the right time, reviewed by the right person, once!”
Achieving that goal required that the project team wholeheartedly to commit to using and integrating the consensus standards ASTM E2500 and ISA-88. Their initial belief, which they later confirmed, was that the combined use of these two standards would result in an efficient streamlined approach that:
- Made effective use of available resources;
- Ensured early stage quality acceptance;
- Integrated equipment and control system testing;
- Used modular software design;
- Reduced life-cycle costs.
The team also became convinced that the lynchpin to success relied on their aggressive and innovative use of a robust MES. (See A Streamlined Approach graphic below) Thus the decision was made to invest the up-front resources necessary to implement a site-wide MES solution and do it before any equipment or control system entities became ready for FAT.
When you look at the product data sheets for any of the available MES solutions on the market, you won’t find a single one that includes a module designed to address verification testing activities. However, BMS engineers recognized that MES-based batch records and verification testing protocols are remarkably similar in that both include a set of instructions, space to record results and sign-off sheets.
Using the models defined in ISA88, Bristol-Myers Squibb wrote its FAT protocols in a modular manner using the Syncade Smart Operations Management Suite master recipe authoring tools from Emerson Process Management. Not only did this prove to be an efficient use of an MES in order to facilitate verification testing, but it also produced protocols that mirror Bristol-Myers Squibb’s production recipe architecture, thereby providing end users with an opportunity to become familiar with the Syncade system.