--- title: Solving Quality and Process Challenges for Medical Manufacturing description: When making instruments or equipment that will be used on the human body there is no room for error. But how do medical manufacturers ensure quality and compliance standards are met in the production process? By digitizing and standardizing operations with open visibility of the entire value chain! image: https://www.eflexsystems.com/hubfs/Medical%20Manufacturing%20-%20Social%20Media.png --- [**Lean Manufacturing Blog](https://www.eflexsystems.com/lean-manufacturing-blog) # Solving Quality and Process Challenges for Medical Manufacturing by [Tina Kennedy](https://www.eflexsystems.com/lean-manufacturing-blog/author/tina-kennedy), on May 6, 2018 3:18:21 PM ![Medical Manufacturing - Social Media](https://www.eflexsystems.com/hs-fs/hubfs/Medical%20Manufacturing%20-%20Social%20Media.png?width=599&height=313&name=Medical%20Manufacturing%20-%20Social%20Media.png) When making instruments or equipment that will be used on the human body there is no room for error.  Consumers want to know that their pacemaker will keep their heart working properly.  The computerized axial tomography (CAT) scan will provide accurate diagnostic data for their physician.  The new orthopedic hip they received will fit properly and get them moving again.  Medical devices are invasive – they cut, examine, and repair the human body.  This is why medical manufacturers must strive for 100% quality standards – while meeting strict regulatory and compliance goals. The challenges from engineering, IT, as well as legal perspectives are great. Medical devices can be very complex, highly engineered products with long manufacturing cycle times and multiple subassemblies in their build process. Think of a surgical robot, X-ray machine or CAT scan.  Engineers are tasked with developing the processes and routing sequences to ensure that every product is built correctly the first time, every time – even when there are numerous engineering changes impacting work-in-process (WIP).   How do medical manufacturers ensure quality and compliance standards are being met?  By digitizing and standardizing operations with open visibility in all areas of the value chain. **STANDARDIZE PROCESSES WITH DIGITAL WORK INSTRUCTIONS** Digitizing operations with electronic work instructions, process routing and error proofing is mandatory, especially in complex medical manufacturing where there can be thousands of product variations and components, loops in processes and clean room assembly requirements.  Digital work instructions offer much more capability than just paper savings. They enforce standardized processes in real-time, with operator validation that each step has been completed correctly, while capturing production data.  If quality issues occur, parts can be contained, repaired or sent to rework stations, with appropriate alerts and notifications until quality issues are resolved.   ![JEMTaskGrid-ProcessDataDisplay-TorqueAngle-Medical-01-02](https://www.eflexsystems.com/hs-fs/hubfs/JEMTaskGrid-ProcessDataDisplay-TorqueAngle-Medical-01-02.jpg?width=434&height=256&name=JEMTaskGrid-ProcessDataDisplay-TorqueAngle-Medical-01-02.jpg)                                                Additionally, if assembly processes are changed or lines are rebalanced – instructions and error proofing immediately change on the plant floor.  Operators at the station level receive notification that a change has been made in the assembly process and provide verification that they have viewed and understand the changes. **INTEGRATE ERP/BOM/BUSINESS SYSTEMS ** Manufacturers do not typically have the luxury of making just one model or product.  At times there are thousands of options.  With that, work instructions should react as BOMs change for a particular model or serial number.  Instructions from one to the other can be very different or require subtle changes which are easy to miss during production.  Real-time, work instruction software should be capable of displaying individual tasks with different instructions and error proofing based on a BOM or model difference*.* **COLLECT REAL-TIME DATA** Work instruction and assembly software on the plant floor must be able to capture critical production data such as operation and task cycle times to help identify overloaded or inefficient stations. Connected devices such as torque tools, barcode readers, pick lights, cobots, vision systems, and more, should feed measurements and data automatically into the system.  Many assembly operations in medical manufacturing are done manually.  Process data for manual operations must be entered and digitally recorded as well. Items could include quality checklist, visual inspection verification, operator approval and sign-off, measurements, pass/fail, etc. Web-based dashboards can then be displayed on plant floor Andon or management offices to visualize production metrics, identify constraints and develop improvement initiatives.  **GET DETAILED BUILD HISTORY AND MEET COMPLIANCE STANDARDS** Capturing process data for every step of the build provides a detailed eDHR (electronic device history record).  Manufactures will have access to who completed jobs, what equipment and tooling was used, measurements tracked, parts used, and who completed inspections and approvals. This is an integral necessity for medical manufacturers to ensure “Proof of Quality” and that products are built correctly.  Also, when electronic signatures and sign-offs are used within the build process for revisions, quality audits or approval processes, FDA 21 CFR Part 11 compliance standards are often met.   **IMPROVED TRAINING & SECURITY** Medical manufacturing often entails highly skilled labor performing manual assembly operations, from fabrication work, special material handling and composites, to machining.  Training time is often much faster and better when digital work instructions are used with text, images, videos or augmented reality features.  Also, when logging into a work station, digital work instructions ensure that operators have the qualification requirements to work within the specified station or with specialized equipment such as cobots. **CONCLUSION** Through digitization of operations, complex product and process configurations become simplified.  Error proofing becomes essential. Data becomes abundant. Operations become leaner.  And ultimately, quality standards and compliance improve.  At eFlex Systems, we’ve created Job Element Monitor (JEM), a web-based, work instruction software application that provides a central system for assembly control, process sequencing, with connected tooling, devices, and kitting operations when and where you need them.  Connect ERP systems and BOMs with JEM, ensuring that complex products with thousands of components are built correctly the first time, every time.  Solve your most complex manufacturing challenges and get the quality standards you and your customers deserve.   Topics:[Educational Topics](https://www.eflexsystems.com/lean-manufacturing-blog/topic/educational-topics)[Technology](https://www.eflexsystems.com/lean-manufacturing-blog/topic/technology)[Medical](https://www.eflexsystems.com/lean-manufacturing-blog/topic/medical) ### The Blog Our team is a creative bunch that loves learning and pushing the limits to find the best solutions for today's lean manufacturers.  Internal discussions at the office might range from new features that manufacturing process control software should have to machine learning, blockchain technology, or what the future of AR on the plant floor looks like. Check out our blog for opinions, news and trends that we find interesting and think you might too!  - [Recent](https://www.eflexsystems.com/lean-manufacturing-blog/solving-quality-and-process-challenges-for-medical-manufacturing#recent) - [Topics](https://www.eflexsystems.com/lean-manufacturing-blog/solving-quality-and-process-challenges-for-medical-manufacturing#topics) - [Archive](https://www.eflexsystems.com/lean-manufacturing-blog/solving-quality-and-process-challenges-for-medical-manufacturing#archive) - [Articles & Publications (7)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/articles-publications) - [Connected Process Control (33)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/connected-process-control) - [Development Process (4)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/development-process) - [Digital Work Instructions (17)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/digital-work-instructions) - [Educational Topics (9)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/educational-topics) - [Events (3)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/events) - [Food Industry (1)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/food-industry) - [Industry 4.0 (32)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/industry-4-0) - [Insider (9)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/insider) - [Kitting (3)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/kitting) - [Lean Manufacturing (42)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/lean-manufacturing) - [Manufacturing Culture (6)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/manufacturing-culture) - [Manufacturing Execution System (1)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/manufacturing-execution-system) - [Manufacturing Integrated Platform (7)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/manufacturing-integrated-platform) - [Medical (2)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/medical) - [News (28)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/news) - [Operator Training (2)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/operator-training) - [Opinion (37)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/opinion) - [Partnerships (3)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/partnerships) - [Press (4)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/press) - [Product Details (2)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/product-details) - [Quality Management (20)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/quality-management) - [Team Building (2)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/team-building) - [Technology (23)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/technology) - [Traceability (6)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/traceability) - [Training (1)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/training) - [Vehicle Assembly (3)](https://www.eflexsystems.com/lean-manufacturing-blog/topic/vehicle-assembly) [More...](https://www.eflexsystems.com/lean-manufacturing-blog/solving-quality-and-process-challenges-for-medical-manufacturing#) - [February 2018 (6)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2018/02) - [May 2018 (6)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2018/05) - [September 2015 (5)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2015/09) - [November 2016 (4)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2016/11) - [May 2022 (4)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2022/05) - [January 2017 (3)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2017/01) - [March 2017 (3)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2017/03) - [June 2018 (3)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2018/06) - [February 2019 (3)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2019/02) - [November 2019 (3)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2019/11) - [February 2022 (3)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2022/02) - [June 2023 (3)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2023/06) - [July 2023 (3)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2023/07) - [November 2023 (3)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2023/11) - [February 2012 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2012/02) - [December 2016 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2016/12) - [March 2018 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2018/03) - [April 2018 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2018/04) - [March 2019 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2019/03) - [July 2019 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2019/07) - [September 2019 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2019/09) - [January 2020 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2020/01) - [January 2022 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2022/01) - [March 2022 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2022/03) - [May 2023 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2023/05) - [August 2023 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2023/08) - [October 2023 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2023/10) - [December 2023 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2023/12) - [January 2024 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2024/01) - [March 2024 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2024/03) - [April 2024 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2024/04) - [November 2024 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2024/11) - [December 2024 (2)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2024/12) - [August 2012 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2012/08) - [November 2012 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2012/11) - [March 2013 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2013/03) - [June 2013 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2013/06) - [September 2013 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2013/09) - [November 2013 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2013/11) - [December 2013 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2013/12) - [February 2014 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2014/02) - [July 2014 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2014/07) - [September 2014 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2014/09) - [February 2015 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2015/02) - [March 2015 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2015/03) - [August 2016 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2016/08) - [October 2016 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2016/10) - [February 2017 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2017/02) - [October 2017 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2017/10) - [July 2018 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2018/07) - [August 2018 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2018/08) - [October 2018 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2018/10) - [January 2019 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2019/01) - [April 2019 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2019/04) - [May 2019 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2019/05) - [June 2019 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2019/06) - [October 2019 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2019/10) - [March 2020 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2020/03) - [June 2020 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2020/06) - [October 2020 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2020/10) - [October 2022 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2022/10) - [April 2023 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2023/04) - [February 2024 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2024/02) - [May 2024 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2024/05) - [June 2024 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2024/06) - [August 2024 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2024/08) - [September 2024 (1)](https://www.eflexsystems.com/lean-manufacturing-blog/archive/2024/09) [More...](https://www.eflexsystems.com/lean-manufacturing-blog/solving-quality-and-process-challenges-for-medical-manufacturing#) **Location eFlex Systems - an Epicor Solution 210 W. Tienken Rd. Rochester Hills, MI 48306 Contact Sales **[sales@eflexsystems.com](mailto:%20sales@eflexsystems.com) - [Request a Demo](https://www.eflexsystems.com/request-a-demo) - [Contact Us](https://www.eflexsystems.com/contact) - [Platform](https://www.eflexsystems.com/platform) - [About Us](https://www.eflexsystems.com/about/about-eflex-systems) - [Blog](https://www.eflexsystems.com/lean-manufacturing-blog) - [Resources](https://www.eflexsystems.com/resource-library) - [Careers](https://epicorsoftware.wd5.myworkdayjobs.com/epicorjobs) - [Open a Ticket](https://epiccare.epicor.com/epiccare) - [Terms of Service](https://www.epicor.com/en/company/compliance/terms/) - [Privacy Policy](https://www.epicor.com/en/company/compliance/privacy/) - Cookie Settings Epicor Connected Process Control **Copyright 2026 Epicor [** ](https://www.linkedin.com/company/eflex-systems)[** ](https://twitter.com/eflexsystems)[** ](https://www.youtube.com/user/eFlexSystems)