This is the second of a two part article summarizing the results of a survey of manufacturing and quality experts who were poled about the most serious manufacturing and quality problems they have incurred.
What’s Wrong with Paper-Based Quality
It is no great surprise that quality is such an overriding concern in pharmaceutical manufacturing. If someone makes a mistake in the iPhone factory, someone’s apps might not work. If someone makes a mistake in a parenterals plant, someone might die. We have little room for error, and yet mistakes do still happen and our best hope is that the most dire consequence is a few more grey hairs on our already suffering heads.
In designing an electronic system for GMP manufacturing we faced the somewhat daunting challenges of not only integrating quality systems into the software but also finding ways that the software could make errors less probable. As part of our market research, we asked several of you to assist us by filling out a questionnaire about quality defects in the current paper-based system and what could be done to fix them.
People are a Bigger Problem than Paper
As with life in general, the biggest problems were linked to human nature rather than mode of recording. Poor communications and laxity among both operators and managers were neck and neck in being blamed for quality problems. On the communications side, respondents told us that many “oops” moments were caused simply by a lack of clarity and transparency among people and groups involved in manufacturing. Poorly worded instructions were misunderstood or vital information simply did not make it to the people who needed to have it (why didn’t anyone tell me we were out of microcrystalline cellulose?). All sorts of headaches were blamed on people being careless or lazy and in some cases just plain stupid. Incorrect calculations not only made it into master batch records but took up residence there for extended periods, like termites in an old house. Data was recorded incorrectly or not at all. Quality issues were identified too late because reporting procedures were not followed and batch records stayed so long in production offices that the pages had yellowed and ink had faded by the time they made the voyage to QA.
Other problems were more clearly linked to the limitations of a paper-based system. The availability of batch documentation to only one person at a time was cited as a cause of delay as well as of ineffectual follow-ups (i.e. CAPAs) when problems occurred. Illegibility of batch records was another problem, especially in the wake of multiple cross-outs. In some cases, numbers were transposed, entries were made in the wrong places, or data was transcribed incorrectly. Coffee, while undeniably critical to quality reviews, was blamed for its bad habit of discoloring batch records, and several respondents noted instances in which pages or even whole batch records had vanished into HEPA-filtered air.
The Paper Chase
One deficiency that stood out for us was the difficulty in finding change control documents and tracking process modifications, as this was one of the frustrations that led us to designing an electronic batch record system in the first place. In theory, it should be easy to pull out a log of change controls and track the whole history of a process, but it never seems to be that simple. In fact, things never seem to be filed where they should be or given names that would allow any reasonable person to find them again.
How Silicon Can Help
Unfortunately, people cannot not be reprogrammed as easily as computers. Bringing the right people on board and training them well can help, but failing an unforeseen leap in evolution, people will always be people, and mistakes will always be made. Nonetheless, there are several aspects of manufacturing quality in which a switch to silicon can be a tremendous boon.
Searchability is one key advantage electronic storage has over paper. Paper-based searching works well if you know where to look and everything is where it should be, but keeping things well organized and indexed and in the right place takes effort, and, well, we’re back to human nature and paper cuts. A well-designed electronic system not only prevents anything from being misplaced but allows unlimited search capabilities and gives you results in an instant.
Another huge advantage of an electronic system is that a computer not only can catch errors but can send off alarm bells in all corners of the earth in real time, days or weeks before a QA reviewer says “wait a minute….” For example, imagine that an operator misweighs an ingredient or stirs for too short a time or tries to start a process at the wrong temperature. The batch record, which is connected electronically to the balance and the stirrer and the thermometer, flashes a warning and an alarm sounds and the operator cannot proceed until he fixes the problem or notes a deviation. A deviation or a problem requiring a CAPA is recorded, and all relevant parties immediately and automatically get an e-mail to that effect. In fact the electronic system can guard against poor communication by automatically communicating any change to everyone who needs to know.
As far as human nature goes, there are a few individuals for whom the optional desk chair electroshock option may need to be installed, but most of us are just too busy and need to be reminded, and, yes, an electronic system can do that too. Like the proverbial horse to water, an electronic system cannot force us not to engage in laziness, carelessness, non-communicativeness, and stupidity, but it can certainly make those activities more challenging.
If you want to make the move or even thinking about making the move to Electronic Batch Records, check out our software solutions for more information on how to make the transition.