Managing Regulatory Change in Process Manufacturing
A recent Sector Insight by the Aberdeen Group defines process manufacturing and sets out some of the challenges faced in the sector:
Process manufacturing involves creating goods from a formula or recipe that cannot be separated back to their individual components. Therefore, the viability of ingredients is important, and manufacturers must be able to identify the source and ultimate destination of products that contain specific components. As a result, rigid regulations, compliance requirements, and variability of raw materials and manufacturing processes create unique requirements for special features within ERP and its modules and extensions.
For those process manufacturers in highly regulated industries, change control is a critical element—perhaps the most critical one—in their management of quality and ability to effectively deal with governance, risk, and compliance (GRC) issues. Inadequate change control functionality and procedures create a massive risk of non-compliance.
GRC expert Metric Stream has an Insight posted in their library that addresses managing change in FDA-regulated process industries, in terms of initiatives to change and what is required to manage it:
The process of change is the end result of initiatives aimed at improving quality, increasing yield, reducing costs, cutting waste, streamlining processes, etc. It would be very difficult to carefully manage change control in a large company or a fast growing organization without an enterprise-wide change control system. One of the most important aspects of change control is to maintain a history of changes for audit trail purpose—a capability better facilitated by such systems.
Among the essential requirements for change control cited:
- End-to-end management of the change control process, including initiating, reviewing, approving, distributing and storing change history. (Such a system can provide evidence of regulatory compliance.)
- The ability to cover a broad set of possibilities, including changes to product formulation or design; upgrades to facilities, utilities, equipment and computer systems, manufacturing instructions, SOPs, test methods, and specifications; any new raw materials; as well as any changes in policy.
- A history of the lifecycle of all change requests: requester name, reviewers’ names, date reviewed, approval date and name, implementation date, and so on. Such information is used during audits to ensure change control procedures are working well.
The Aberdeen study notes that process manufacturing organizations need to have traceability capabilities as well as controls in place to ensure regulatory compliance. This is especially essential in the case of recalls.
In looking at essential ERP requirements for process manufacturers, Aberdeen notes that leaders considerably outstrip followers in terms of the ability to do the following: do a mock or real recall, do demand planning and forecasting, establish a central repository of metrics and KPIs available on demand, and provide automatic alerts of non-compliance. “By selecting ERP solutions that support these processes, process manufacturers can help to ensure that quality products are received by customers and that their organization is able to escape the fines and poor public perception that comes [with non-compliance],” the report concludes.
Posted by Tom Muth, Senior Manager, Product Marketing