In the world of medical device manufacturing, mistakes on the plant floor can have dire consequences. Medical manufacturers make products that involve life and health, and when there’s a quality issue, someone can die. That’s why the medical device industry is so stringently regulated, and why meeting Food and Drug Administration requirements such as 21 CFR Part 820, 21 CFR Part 11 and ISO 13485 are so critical to a manufacturer’s success.This blog covers important reasons why medical device manufacturers need manufacturing operations management (MOM).
Manual Device History Records
The FDA’s Quality System Regulation (21 CFR Part 820) requires medical device manufacturers to establish and maintain Device History Records (DHR) for each batch, lot, and unit they produce. DHR software is an electronic compilation of all records pertaining to the production of a finished medical device, and a massive amount of time can be spent to update the records, because every operational step requires documentation.
Every action taken relating to a device (e.g., who worked on it, their certifications, what parts and tools were used, what tests were performed, etc.) updates the DHR. Eventually, a quality inspector comes in, typically at the very last step, and spends hours reviewing the DHR to make sure that every piece of paper that should be present for documentation is there. This step must be in place before the product can ship to verify that the device was built as designed.
Automating DHR with MOM
Clearly, the manual DHR process is cumbersome, and prone to errors. However, there is a better way. Medical device manufacturers can use a Manufacturing Operations Management (MOM) solution to automate almost everything affecting the DHR. This saves a tremendous amount of time and effort while driving down the risk associated with human error.
For a manufacturer without an MOM solution, the DHR review process can easily take hours per device. With an MOM, the eDHR (electronic DHR) must still be reviewed, but the process takes minutes, not hours, as the eDHR is automatically generated and updated.
While providing the ability to meet this most trying part of FDA regulations better, faster, and more cost efficiently may be a primary reason for justifying MOM to medical device manufacturers, it is only one point among many.
Four Key Drivers About Manufacturing Operations Management for Medical Device Manufacturers
There are four principal reasons that medical manufacturers need a manufacturing quality and execution system such as MOM in today’s increasingly competitive global marketplace:
- The cost of quality must be reduced.
- Quality is highly dependent on timely and accurate information.
- Customers no longer tolerate defects.
- New product introduction is accelerating.
- Engineering changes are more frequent.
- Information must be distributed from design through packaging.
- Schedules and production rates must be met.
- Paper updates are already late.
- Changes must be immediate.
- Continuous improvement is imperative.
- What has worked in the past is no longer valid.
- Competitors are changing rapidly as well.
Important Misconceptions About Manufacturing Operations Management for Medical Device Manufacturers
Many manufacturers think that having an Enterprise Resource Planning (ERP) or Quality Management System (QMS) in place obviates the need for MOM. In both cases, this is a misconception.
Typical QMS processes involve more than a little time in Excel hell:
- Fifteen percent of an organization’s revenue is spent creating, managing, and distributing documents.
- A paper document is lost every 12 seconds.
- The average time to retrieve or re-file a paper document is 10 minutes.
- The typical office worker makes 61 trips per week to the fax machine, printer, and copier.
- Manual data entry is error prone; roughly seven errors occur for every 100 entries.
- Each time a technician stops to enter repetitive information, it takes seven minutes to restart from the position left.
Further, ERP is normally not designed for the specific needs of medical device manufacturers. It is a paper driven transaction-based platform, not real time, financially driven, and is often large, cumbersome, and complicated. Owned by IT and Finance, it tends to treat manufacturing as a black box.
Using MOM to Drive Out Waste in Medical Device Manufacturing
An analysis of Fortune 100 manufacturers shows five basic operational waste drivers: non-value indirect labor, scrap, rework and obsolescence, direct labor, warranty costs, and paper/storage.
Expand on each of these five in an ebook chapter.
iBASEt’s Solumina cuts out waste across all operational drivers:
- Reduces non-value indirect labor by 15 percent.
- Planners can put orders on hold from their desks and process necessary changes in minutes.
- Eliminates re-entering/verifying data.
- Eliminates support tasks (e.g., printing work orders, specs, drawings).
- Enables search of as-built archives in minutes.
- Eliminates lost paperwork issues.
- Reduces scrap, rework, and obsolescence by 25 percent.
- Repetitive defects are avoided through visual alerts on parts.
- Engineering changes are processes in minutes, ensuring that parts are produced right the first time.
- Techs can see defect history on any part or process and can see how problems were resolved.
- Graphical instructions are easy to understand and retain.
- Reduces direct labor costs by 15 percent.
- Time spent looking for, deciphering, and disseminating information is cut in half.
- New technicians learn faster and retain knowledge better.
- Techs can forward changes and suggestions to engineering, leaving shift transfer notes.
- Reduces warranty costs by 30 percent.
- Ensures that fewer escapes occur.
- Traceability/work history helps determine which products should or should not be repaired under warranty.
- Recalls are surgical.
- Warranty work instructions can be delivered directly to the customer’s facility.
- Reduces paper and storage costs by 90 percent.
- Eliminates paper creation, copying, loss, archiving, and retrieval.
- Eliminates labor to collate data.
- ECOs take minutes to process.
- Data is always current—no more problems with latency.
To create the best business case for implementing MOM, be sure to talk to the decision-maker or decision-makers, quantify the benefits to be gained, quantify the costs (TCO, capitalized, and non-capitalized costs), and create the Return on Investment. Show value as well as need.
- Benefits of Dock to Stock (DTS) Programs for Complex Discrete Manufacturers - February 13, 2017
- Why a Quality Management System Isn’t Enough to Satisfy 21 CFR Part 820 and Part 11 - January 3, 2017
- Why Medical Manufacturers Need Manufacturing Operations Management (MOM) - December 15, 2016
- Does Your MES Support Effective Product Genealogy for Medical Device Manufacturing? - October 6, 2016
- Achieve Cradle-to-Grave Bi-Directional Traceability with Best-of-Breed MOM - July 15, 2016
- A Better Approach to Maintaining Device History Records - March 1, 2016
- New Acronyms from the FDA: UDI and GUDID - January 28, 2016
- MOM Can Help with Your Complaint System - December 10, 2015
- Tackling Medical Device CAPA Deficiencies - November 17, 2015
- FDA Software Validations Are Tied to Manufacturer’s Implementation - November 10, 2015