Imagine that you’re driving your car after a long, tiring day. For a brief moment, you get distracted and deviate toward the white lane markings. Immediately, your car’s lane-keeping assistance system detects a change in the position of your vehicle and corrects that. What does this have to do with compliance?
Well, everything actually – regulations can be considered the white lane markings. Crossing them imposes a risk. Your QMS should function as your lane-keeping assistant, guarding compliance while you experience a comfortable ride through your processes.
Traditionally, compliance was a pharma or life science topic, primarily enforced by regulating bodies like the FDA. These days, however, all industries, including the more pragmatic ones, see increasing pressure in adhering to regulations. So how can manufacturers ensure compliance while maintaining their pragmatic approach and competitiveness? And what are the risks of non-compliance? That’s what this article is about.
Not just an administrative burden
Based on the example above, you can imagine that manufacturers operating in a fully-fledged regulated industry are driving on a straight road, with no shortcuts and no overtaking. You might even think of it as a railway track, more than a highway.
And, while those operating in a non- or less regulated industry may enjoy more flexibility, it doesn’t mean that they should completely ignore compliance requirements or view these as an administrative burden alone. There is clear value in compliance. Understanding the risks the requirements try to eliminate will help any manufacturer to improve process predictability and resilience. This also relates to process adherence: if the compliance adds complexity or admin burden, people are likely to bypass it. Keeping it simple and clear is the key.
With the ongoing trend of increasing regulation, compliance should be on every quality leader’s agenda no matter their industry. Some of the initiatives that demand manufacturers to design and document compliant processes and ensure their correct execution are:
- Customers who demand more detailed reports on quality performance and behavior and audits that push for standardization and process adherence
- Strategic commercial pressure to get prepared for new certifications to enter new markets, while remaining competitive
- Corporate programs that attempt to harmonize and standardize operations, requiring processes to align with corporate standards
- In-plant operational excellence programs that require increased process adherence
The risks of non-compliance
Non-compliance exposes manufacturers to risks. This can be anything from missing data making reporting and analysis difficult to incomplete process steps that can lead to rework and producing more waste. Not to mention adding stress to audits since there is no guarantee of employees complying with the pre-defined quality processes.
In a mature and predictable environment, process adherence is of utmost importance. This was also one of the key findings in Gartner’s ‘Quality Process Adoption: emphasizing value isn’t enough.’ According to this report, an average of 45% of customer complaints could be traced back to employees skipping quality processes which led to warranty claims, rework, and ultimately lost customers.
Motivated to work compliantly
So how can you prevent compliance issues? In a perfect world, the defined process is the best and shortest way to meet the strategic targets of our company. While it’s not difficult to imagine the benefits of process adherence, picturing all the ways in which you can motivate your employees to work compliantly may be rather blurry. Here are a few helpful tips:
- Whether internal or external requirements, they need to make sense. And people need to understand why they make sense. Helping people to gain the license-to-operate perspective, or the best-practice perspective goes a long way.
- Make processes as easy as possible. Employees use quick and easy solutions outside of work, making processes quick and easy increases adherence.
- Focus on clear-to-follow processes. Everybody should know their role – who should be completing processes, how, and when. Guidance, training, and comprehensive instructions instead of too much detail will greatly influence attitudes towards a process.
- Make sure your defined processes capture all the corporate strategic targets. Gaining alignment and taking process adherence outside of the quality department can lead to noticeable improvements.
Next time we’ll talk about 6 new features that enable AlisQI customers to seamlessly incorporate compliance requirements into their quality operation. In the meantime, do not hesitate to contact us should you have questions regarding compliance and how to turn this into a smooth ride.
