Everyone is talking about Digital Transformation, along with IoT, Analytics, Big Data and many more such trends. If you are a manufacturing company, you can add Industry 4.0 and Industrial IoT to the list.

Do I need to Digitally Transform my Business in order to keep pace with my Competitors?

Or is it another trend and buzz word that will be replaced by another one in a couple of years?

There are many definitions of Digital Transformation, Dataworks has been engaged in delivering digital transformations, of one kind or another, to our customers for over 20 years now. In its most basic form, we believe it’s the use of technology to solve traditional problems rather than using manual or paper-based solutions to solve these problems. There can be no doubt that there are several new and emerging technologies that present opportunities to companies to streamline, improve and transform their business, whether within the four walls of their manufacturing site, which would be our main focus, or across their entire supply chain.

Digital Transformation – Maximising The Opportunities

At Dataworks we supply solutions and related services to the Medical Device and Pharma sectors. The Life Science Sector has traditionally relied on paper-based systems to meet their compliance objectives and to manage their manufacturing processes. Medical Device companies have been heavily engaged in Lean and Continuous Improvement activities for many years to ensure that they can be as efficient as possible. Many have achieved or are pursuing Enterprise Excellence accreditations such as the Shingo Award for Enterprise Excellence. While the kernel of these initiatives is culture change, and focusing on principles, desired behaviours and people development, there can be no doubt that in today’s world, technology should in our mind, be a key component. In the broader context, people don’t want ‘digital’ for everything, and certainly within a manufacturing context you do not want to eliminate human interaction and teamwork.

We believe that within a manufacturing site, by embracing a digital transformation strategy, the site can leverage opportunities presented by technology and help accelerate improvements and allow people at all levels of the organisation deliver more and be more innovative in terms of performing their core tasks, but also in coming up with new ways to help drive better outcomes for their own personal development, the business in general, and ultimately their customers.

Taking a Disconnected Approach will not Deliver Transformation

For the past number of years, we have focused on the delivery of Manufacturing Execution Systems into predominantly Medical Device or Medical Supply companies. Many organisations embark on “automating /digitizing” some aspect of their manufacturing activities – be that new automation, automated inspection systems, or solutions to collect as much data as they can – because everyone else seems to have a “Big Data & Analytics Strategy”. A large number of the next tier of companies, in terms of size and budget, have not even begun to look at any form of computerisation or digital transformation at an Operations Management of Batch Record level. This may be partly due to budget, partly due to fear, and partly due to “where do we start”.

Addressing The Critical Challenges

We believe that the four critical challenges for these companies are:

• Keeping to strict production and delivery schedules

• Increasing efficiency throughout the site

• Ensuring compliance with regulations

• Driving continuous improvement to stay competitive and build a culture of operational excellence

So how do you try and leverage technology to digitally transformation your processes and help address these challenges in a way that will be truly transformational for the people within your site, and meet the financial ROI that will be required?

Many companies focus on one of the above challenges and do make significant gains. This may be focusing on automating production processes and or collecting more data about your process to ensure you are meeting deliveries as efficiently as possible. Others focus on moving from a paper- based batch record and associated log books to a “paperless” or electronic batch record, which dramatically reduces the number of human errors and ultimately provides savings in the QC and QA release processes. From our experience, those that focus on moving to an electronic batch record without considering the possibilities to truly transform how production activities are executed, monitored and controlled, are missing a huge opportunity, and may in fact yield savings in one area while incurring unplanned additional costs in another area, thereby ending up with at best with a new way of doing things, but one which has not delivered any real benefits.

Improving Quality and Operations Management through Digital Transformation

While many medical device companies have several steps in their manufacturing process, a number of which cannot be fully automated without incurring great costs, software solutions such as MES can help transform the entire manufacturing operations and quality activities in harmony. Manufacturing processes have long been paper-based with increasing batch record entries and logbook entries, which have grown from specific quality issues or non-conformances. An issue occurs, quality put in a check, which has to be initialled and counter signed, as a stop gap while a root cause analysis is performed. If the root cause is found, is the additional log book or revision to the paper batch record ever rolled back? Our experience is that it rarely happens – so the net result is extra recording of information, extra checking by QA inspectors, and extra counter checking by QA release. Each new entry, or log book entry is an extra task for operations.

By digitally transforming your operations, in a manner which builds quality into your process and meets your regulatory requirements, you can “have it all”. The quality function is streamlined, more “right first time”, less non-conformances, and a move to or towards “release by exception”. And operations have live data that can provide greater insights into how they are performing against targets, and have systems that can transform how they conduct their daily Gemba walks or Tier meetings, and have the correct balance of technology driven visual management and tools which really engage the people and drive a culture of continual improvement. This is not to mention the benefits that can be accrued by Lean and Engineering groups who really have accurate data to base studies and improvement projects on facts and not hunches.

Embrace technology NOW, start your digital transformation journey TODAY.

For over 23 years the team at Dataworks have helped leaders in the Life Sciences Industry deliver better outcomes through digital transformation. If you would like to learn about how we can help you Contact us today.