FDA Compliance / Automation
Validation of Automated Systems for FDA Compliance
Two simple spreadsheets were quickly developed to request modifications as needed and to post, daily, the last 30 modifications completed, sorted by unit. Unknown to the DCS support group at the time, all of these documents would become the infrastructure of the DCS Quality System. Development of the ‘e-records’ from DCS itself continues to evolve and improve, and has provided countless opportunities to support the work of the DCS group, which maintains it. The DCS Quality Control Log Sheet documents every modification made by date, item modified (i.e. tag, program, graphic), short description and initials of the person making the modification. This historical value of this database is priceless as it is referred to on a regular basis: The log sheet is an invaluable tool for troubleshooting the performance history of a specific loop or program.Queries are made regularly to determine the number of modifications performed concerning a specific tag or program, when they’re made, and what modifications’re made. The log sheet entry identifies the original process automation request in the quality record filing system by date if more detail is needed concerning the modifications made.
What to Do With Equipment Shutdowns
Start-ups and shutdowns of BPCS and SIS equipment are rare enough that even experienced DCS support personnel need reminders of the most efficient method to minimise the downtime of the process units.
The BPCS/SIS Start-up Checklist has been used on many occasions, such as unexpected power failures, post-software upgrades check-outs, and planned maintenance outages. The checklist continuously improves as more items are added which further ensure the systems are operating properly after any interruption. The ‘shutdown procedure’ has also proven beneficial because it documents a complete system shutdown, as well as the most effective partial shutdown of the automation equipment. In the event of an unplanned power outage, the BPCS and SIS are operating from limited UPS battery sources. A partial shutdown procedure documents the most effective way to conserve energy without losing the process controlling components and providing minimal operator interfaces.
Strategy Makes the Difference – Efforts Are Investments!
On several occasions, this strategy has made the difference between no shutdown at all and a two-hour start-up of the BPCS equipment at a time when this equipment is urgently needed. Previous annual releases of
some documents are kept on file as quality records for some specified number of years. An example of such a document is the units’ interlock matrices. The interlock systems, both process and safety, are documented using a cause/effect matrix methodology. The previous five (+) annual releases of these matrices are available on file, and have been used on several occasions to discuss the history and evolution of the interlock system.
Thus, the efforts to validate the automation system enable one to maintain and improve the system have been – and are genuine investments in time and patience. However, the documented knowledge-base which has grown as a result of this commitment over the last few years has been well worth these investments for those of us who currently support and operate the equipment and for those who will follow us in the future.