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Future Ready for Audit, Ready for MES?

September 12, 2018

Future Ready for Audit, Ready for MES?

Written by:
Chris Parsons
VP Marketing at Critical Manufacturing

Instead of a painful, time-consuming and costly process, what if being audited by the FDA, or any other regulatory body, was just part of the day to day routine? After all, the FDA is looking to shift the focus from inspecting product quality in at the end of a process, to ensuring quality is built in. For the MedTech industry this makes perfect sense – it would not only reduce the financial overheads associated with being audited, it would also substantially reduce time and business risk.

With its ‘Case for Quality’, the FDA is looking to identify medical device manufacturers that consistently produce high quality devices. By doing this, it can align audit frequency and compliance approaches to business risk. To consistently show exceptional levels of quality and quality improvements may, therefore, result in less frequent audits and, by default, less overheads associated with exception reporting, paperwork trails and, the ultimate woe – a product recall.

Sounds like a nice prospect, doesn’t it?

But how can companies achieve such aspirations?

It requires a change in approach to quality and data collected during production processes.

Surely, all medical device manufacturers focus on product quality – but do they? A focus on quality is not an inspection at the end and then re-work, more paperwork or exception reporting. It assumes compliance is a baseline, a starting point on which to build even higher quality results. This involves continuous improvement of medical device designs, processes and more rapid identification and action if a problem does arise.


Download Case Study:

Case Study: MES for Medical Device Manufacturing. Moving faster from development to full-scale production
by Critical Manufacturing

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This case study describes an MES implementation with our customer, a leading international Medical Device Manufacturing company. The MES solution was deployed at a US site to develop product and processes for fabricating complex imaging devices and support their move from development to full scale production.


To enable continuous improvement of devices and processes, vast amounts of data needs to be collected and analysed to gain strategic insight into where errors can occur and where to proactively focus resources for prevention, leading to higher quality. Once achieved, the FDA needs to be able to see proof of product quality levels, so it can evaluate the risk associated with a manufacturer or production site and establish whether audits frequency needs to increase or decrease.

Stop: Did this just say audit frequency may increase if the FDA has more visibility of production data?

Yes, it did. And, of course, it would – if quality was not at acceptable levels. The whole point here, though, is that systems are put in place so quality increases. It is simple math – if quality levels improve this means:

  • Potentially fewer audits
  • Much more straightforward audits when they occur, because production data is readily available
  • More efficient production – fewer errors reduces production overheads and cost
  • Less time fixing problems, means more time to invest in innovation and product improvements
  • Less risk to the business – less chance of a product recall, increased profitability on product lines, and stronger brand reputation – after all, it’s not just the FDA who cares how good the medical device is, excellent patient outcomes lead to higher brand reputation and profitability.

At this point, it must be said that the huge potential cost savings and competitive edge this lofty level of quality could bring surely makes it a ‘no brainer’.

Still not convinced? Some data to back this up:

As part of research by Axendia, the leading analyst and strategic advisory firm for the life sciences industry, 54% of product recalls were associated with manufacturing quality related issues.




By producing a two or three sigma product, it is estimated that compliance becomes 20-30% of the cost. Improving quality to a six-sigma product reduces this to 2-3% - and this goes straight to the business’ bottom line.

Prevention is better than cure

An age-old saying in matters of healthcare, ‘prevention is better than cure’ rings true for MedTech manufacturing processes. In other Axendia research, 85% of medical industry practitioners questioned said the role of quality was compliance. Only 10% stated that their role was process or product improvement. How can this change? The answer comes back to data and how it is handled.

We live in a digital world surrounded by ‘Big Data’. For medical device manufacturers, if real time processing data can be captured, analysed and translated into meaningful, actionable data; operators have the power to make adjustments before an error occurs. This same data can be used to give insight into products and processes, signpost ways to make production more efficient and, importantly, automatically provide complete, digital audit trails for a product. Everything that happens to a product can be recorded; including process measurements, metadata, machine calibration records and operator training / certification records.

So, by digitizing processes, data is ready on hand for review internally or by an auditor. Also, as processing issues are dealt with contemporaneously, as opposed to adding detail to paper after they happen, the potential for human error is significantly reduced. Another interesting piece of data: Some 80% of FDA notice of violations (form 483, commonly termed as a ‘483’) are not because of a fault in the process or procedure, but because of human error in not following procedure or erroneous manual data entry. Even at the most basic level, having documentation and information about processes quickly available wherever and whenever needed, reduces the man hours needed to prepare for an audit. It shows processes are under control, gives authorities confidence that this is the case and decreases the amount of opportunities for a business to receive ‘483s’ or other written warnings.

Embracing digitization – can MedTech businesses afford not to?

Systems and help are out there to support the ‘Case for Quality’ and continuous process improvements in the MedTech industry. There are huge advantages to be gained in production efficiency, facilitation of innovation and faster new product introduction. For the MedTech industry, however, the costs to be saved in audit overheads alone, make the investment in a modern, digital Manufacturing Execution System (MES) a sound business investment to focus on product quality and make compliance a natural result of excellent production processes.


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