As the industry gears up to fully embrace ISO 9001:2015, multiple questions still hang in the air. Anytime people talk about quality management systems or the subject of TQM in general, one thing is bound to pop up: automation. Technology was supposed to save us from the worst of management, freeing us from the drudgery and giving us chances to improve quality at every level.
Unfortunately, technology in real time has been more or less both a blessing and a curse. In order for a company to move forward, a careful study of automation has to be considered against other methods, as far as compliance goes.
The need for compliance is obvious: adhering to a higher standard means better output across the board. If part of your job’s compensation is based on the company’s performance, then quality management is very important to you.
Let’s use the pharmaceutical industry as an example. Compounding pharmacies are a hot button topic that gets plenty of heads turning. There was a compounding pharmacy that saw people experience bad health and even death from tainted steroid injections. The flaw in the process was obvious: manual processing instead of automation. Automation was the future, where a consistent dosage could be measured for each and every customer, rather than leaving things up to human operators. Although skilled, there was still room for these operators to make mistakes, costly ones that cost people their lives.
Automated systems aren’t new, but people still distrust them. We’ve all seen movies about robotic operations that start out great, but end up harming humans as the machines begin to break down or worse, take over. We’re a long way from robots turning on us, but there are still some technological concerns that need to be addressed before consumers and companies alike feel like investing wholeheartedly in the process.
Can automation ensure compliance? That’s the big question that has to be answered in layers. First and foremost, careful planning has to go into the automation design. We can’t just think of automation as something that we set up and then forget about. Every system has to be monitored regularly in order to ensure performance is at an optimal level.
If your organization has a talented design team, then automation will help ensure compliance. But if there aren’t any checks made on the automation processes, then errors can creep into the system. This leaves you in the same vulnerable position as with manual handling.
Is it time to make a change? Only the internal committees can come together and determine if that’s the case. Change within an organization can be slow depending on size. If there’s a lot on the line, many companies will opt for a more conservative approach, which can cost them in terms of getting things up to speed quickly.
Consider all of the options, and then go with the one that aligns best with your organization’s goals. Good luck!
