- For Your Industry
9 min read
What The Doc Ordered: Better Performance in Medical Manufacturing
The landscape of medical manufacturing has gotten more complex.
- Pandemic related shutdowns created global supply chain disruptions
- A batch of macroeconomic and regulatory headwinds are increasing costs
- We are seeing labor shortages and supply chain snags
- Strict FDA restrictions require first class strict compliance protocols
And yet, medical manufacturers are still driving incredible technological advancements.
Producing medicines and equipment that improve human existence.
Dozuki works with several brands in the medical manufacturing industry. Below, we’re going to share success stories from our customers, insights gleaned, and tactics you can put into action immediately to build the frontline of the future.
Enable Document Control for Audit Trails
In pharmaceutical, biotech and other medical manufacturing facilities, there is no room for deviating from approved operating procedures. Any change to the working standard can have far reaching consequences for employees, organizations and consumers.
More specifically, meeting FDA guidelines across systems and processes is no small achievement. Auditors expect full visibility into document history and corrective actions, training history of frontline workers, and validated testing of software.
Dozuki has deep expertise in helping medical manufacturers achieve and maintain this kind of compliance. Just recently, we spoke with the training manager for a healthcare company, whose concern was not uncommon.
He said the lack of version control in their homegrown training tracker was preventing operators and managers from using it. Most of the protests came from most managers who couldn’t track training across multiple shifts and lines.
They said the auditors always want us to show them exactly which employees have been trained on which processes and equipment. But they didn’t have a recent training record with status updates from past months that’s consistent across the organization.
All medical manufacturers can relate to this struggle. Your number one issue is control. The cost of regulatory noncompliance in the medical industry is not worth the gamble. Every year, organizations lose millions of dollars due compliance issues and related lawsuits. And it’s worth every bit of time, money and energy to preserve that control to the best of your abilities.
Do you have an audit trail attached to all of your documents? How easily can frontline operators and supervisors view each version?
Companies that rely on outdated, paper based, manual documentation can’t answer such questions. Or if they can, doing so is highly labor intensive and frustrating. What’s more, if certain mistakes are made, people’s lives are at stake.
One way to ensure this box gets checked is with digital records for processes and training. Dozuki’s platform lets you view the revision history, with each version going back to the creation of the documents. You can see each individual change as well, and the timestamp gets automatically captured anytime anyone makes a revision in the future.
One operator can show the training report to the auditor, and they will never ask for proof from anyone else. Compliance crisis averted.
Satisfy Compliance & Quality Simultaneously
Many medical companies are process manufacturers, meaning, their production method creates goods by combining supplies, ingredients or raw materials using a formula or recipe. This approach is frequently used in industries that produce bulk quantities of goods, like in pharmaceuticals, chemicals and plastics.
But the nature of such a process means compliance must be more seamless and manageable.
For your reference, The Food and Drug Administration (FDA) officially defines a compliant product as one that is safe and effective. The government states:
The company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards. If the FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use.
If medical manufacturers follow this logic, regulatory compliance can and should be considered synonymous with product quality.
The challenge is keeping it consistent across multiple lines, shifts and facilities.
Dozuki has a customer in the healthcare space that came to us with a significant challenge around compliance. According to their numbers, fifty percent of their quality audit failures were due to work instructions not being followed. Most employees had not read or been trained with instructions; either because they over relied on job shadowing with veteran team members, or because the instructions themselves were outdated.
When our team took a look at the current process for refining work instructions, their quality problem became crystal clear. Even they admitted just how convoluted the whole journey was. Just imagine if your medical manufacturing company had to perform the following steps each time one of your processes was updated:
- Find documents that need updates
- Search the folder of pending instructions for the document number you need
- Retrieve the original from the master vault
- Make a copy and place in folder for pending work instructions
- Add your name to the end of the document title
- Make all necessary changes to the document
- Send the updated document out for approval
- Update the approval dates in the document
- Locate the original document in the master vault and rename it
- Move the renamed original into the archive folder
- Take new document from the pending folder and remove your name from it
- Move the new document into the master value
- Verify shortcuts for your doc are working correctly
- Work instruction update complete
That’s a big process pill to swallow.
It’s no surprise their documents were outdated, and audit failures happened so frequently! A convoluted process like this has severe limitations that prevent updates from being effectively pushed out.
Dozuki helped them create accurate process documents which could be quickly and consistently updated as processes change. What’s more, those assets were actively referenced by frontline employees doing the work in order to ensure consistent execution.
Ultimately, whether your company produces medical equipment, pharmaceuticals or other healthcare products, navigating the changing landscape of this industry will not be an easy or short journey.
But if you’re disciplined about enabling document control, and satisfying compliance and quality simultaneously, your audit trail will be a much healthier experience.
And it will only be a matter of time before your facility produces the next great medical breakthrough and application.
Topic(s): Industry News
Written by Scott Ginsberg
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