Chemicals manufacturers in the last half of the 20th century and the beginning of the 21st century have seen the challenge of regulations that govern chemical manufacturing processes become a burgeoning issue that often results in serious problems and expensive repercussions.
Some of the regulations that chemical manufacturers must adhere to include the following:
- EPA Regulations
- cGMP Requirements
- OSHA Requirements
- REACH Regulations
International ISO Standards
Meeting international ISO standards is also very desirable in a chemical manufacturing environment since 1) ISO standards are international standards that helps create a quality benchmarks for chemical manufacturers across the globe and 2) ISO standards are a trademark symbol of quality that are often looked for by potential investors. To “keep up” with the demand required to comply with these regulations, chemical manufacturer facilities hire quality managers and quality personnel, many of whom are frustrated with manual paper routing and manual approval processes as well as quality processes (e.g, audits, CAPAs, etc.) that are observed, analyzed or resolved too slowly to eradicate or even improve a chemical company’s level of deviations, nonconformance events and recommended process changes or corrective actions.
Document Management Systems for Chemicals Manufacturers
Document management systems are literally the lifeblood of quality management systems. Document management systems keep SOPs, quality manuals, batch records and other documentation under lock and key and under strict controls with secure online collaboration, version controls, automated audit trails, signature manifests and electronic reporting and analytics tools. Quick search and retrieval functionalities are also important and should be available in the system of choice. Some document management systems can also be purchased as small, out-of-the-box (far less expensive) solutions that can grow as a company does.
Training Management for Chemicals Manufacturers
Training management is another problem area for chemicals manufacturers. Various chemical manufacturing regulations stipulate the need for training so that chemicals manufacturing employees have been documented as having the skills necessary to perform their assigned duties. Chemicals manufacturers, when searching through a myriad of document management systems should search for a document management system that integrates with a training management solution in such a way that a training course or a series of training units could be automatically launched to all relevant employees when a document has undergone what the company defines as a “training worthy” (i.e, major) revision. The training management solution should also provide automated exam deliveries and automated exam grading as well as audit trails (based on training data) and training reports and analytics. Training reports should also be able to be delivered automatically over regular time intervals (i.e, week-by-week, month-by-month, etc).
Total Quality Management for Chemicals Manufacturers
Once a chemical manufacturer has searched through various document management systems that provide integrated training management he or she must then sort through the remaining document management systems again to ensure that the system of his or her choice also provides integrated total quality management functionality. This functionality should streamline the processes required for total quality such as deviations, nonconformance event, customer complaints, audit, change control and CAPA processes. Complete process lifecycle management should also be available with the system.
Document management systems, in today’s highly-regulated world, should be more than document management systems. They should be easily integrated with training and total quality management functionalities.
By: Marci Lynn Crane