Bottom Line: Quality must become the catalyst that unifies the diverse departments of any organization if it is going to strive. The moment of truth for any company that competes in highly regulated industries including Medical Devices and Medical Equipment manufacturing is defined by how they are progressing towards quality goals and objectives.
Paperless Manufacturing Execution Systems (MES) built to understand the complexities and requirements of highly regulated industries are a manufacturers’ best bet for accelerating quality in 2016. The reasons why are discussed below:
- Medical Devices/Equipment is one of the most highly regulated industries, requiring intensive reporting to support internal and external reporting requirements. Strict government oversight and industry regulations including complex compliance requirements, place quality at the forefront regarding importance.
- Streamlining and simplifying complex regulatory reporting requirements, freeing up time to focus on core business and customer requirements. Complete MES solutions have the ability to streamline and automate essential regulatory processes to ensure FDA, ISO and GMP compliance and reporting requirements are met.
5 Ways Manufacturing Execution Systems are accelerating quality on your shop floor in 2016
1. Complete eDHR Reporting
Maintaining accurate, complete as-built electronic device history records (eDHR) for produced products ensures traceability, quality and regulatory (21 CFR 820) requirements are met. Manufacturing Execution Systems (MES) incorporate true eDHR reporting capabilities by automatically collecting information on consumed components and materials authorized for assembly into the product, certifications of the workers assembling the product, and any validation activities. Other major enterprise applications typically leverage a hybrid approach to producing an eDHR through one of the following two ways: convert paper DHR into electronic form through manual data entry or scanning paper DHR documents to PDF. These approaches place the organization at unnecessary risk.
Since eDHR reports create a complete system of record, leadership, as well as other continuous improvement personnel, can analyze the data consumed in the report to gain insights into areas of production and quality that are deficient or subpar. Leveraging this insight to developing better manufacturing and quality processes will have tremendous upside on an organization’s bottom line: reducing scrap and rework, producing a product faster, maintaining compliance, and lastly providing your customers with an excellent product.
2. Closed-loop CAPA
Similar to Device History Records, Medical Device companies are required by the FDA to have Corrective and Preventive Action (CAPA) procedures in place to identify, prevent and correct quality non-conformances. Corrective and Preventative Actions are crucial to maintaining a good quality system and preventing reoccurring defects. Leveraging a closed-loop CAPA system that works hand in hand with your current PLM and ERP system should be an important part of your organization to help resolve non-conformance issues and minimize risk. CAPA and all related procedures are automatically updated to your Device Master Record (DMR) and eDHR.
CAPA deficiencies are a major culprit in manufacturers receiving FDA warning letters. Without an effective CAPA system in place, medical device manufacturers risk not meeting FDA compliance requirements, ultimately hurting the bottom line and potentially putting customers’ in harm’s way. Initiating, implementing, and verifying – closing the loop – on CAPA processes ensures the changes made to non-conforming processes were effective. An MES guarantees CAPA procedures are executed and automatically records that processes in the eDHR, supporting better production execution and quality standards.
3. Collaborative Supplier Quality Management
Even in today’s high-tech world, communication among manufacturers and suppliers is still relatively poor with many manufacturers still rely on managing the supply chain via monthly phone calls. This decreases supplier performance and increases scrap/waste, ultimately hurting everyone’s bottom line. Positioning your organization to continually improve in areas like supplier quality, with an MES solution, will streamline collaboration, compliance and quality workflows across the supplier network. Developing a more collaborative environment for suppliers provides unprecedented visibility into their manufacturing processes, helping to control production costs and quality standards for your organization. Product and inspection specifications, including product characteristics, tolerances, and rules for sampling, oversight, and audits, sent over to suppliers provides clear direction on what the requirements are.
In today’s increasingly stringent government standards for medical device manufacturers, it’s especially important to leverage a tight, collaborative supplier quality management solution that improves parts quality, reduces quality escapes, minimizes receiving inspection, and reduces audit oversight costs, to ensure your organization remains compliant and competitive in this fierce market.
4. Integrated Complaint Handling
According to the FDA, not only do medical device manufacturers need to have an appropriate quality management system and procedures in place, but they must also have a system for tracking and handling complaints regarding their products. The FDA defines a complaint as, “[a]ny written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” Taking advantage of a manufacturing executions systems’ consolidated and integrated approach to quality management, complaint files are maintained and procedures are established for receiving, reviewing, and evaluating complaints. Relying on disparate, manual reporting systems increases the risk of running into problems with inconsistent and incomplete reporting of adverse events, which can lead to numerous other challenges, including delayed response and reporting to FDA, improper investigation and determination of cause, and inadequate corrective or preventive action.
An MES solution with an integrated complaint system helps to safeguard your organization from major challenges that may negatively impact your patients, products, and reputation – preserving manufacturability.
5. Tooling Management
Most manufacturers today currently don’t have a good way of tracking and auditing tools being used throughout production. An MES with tooling management capabilities provides the necessary means to ensure consistent quality. Information about a tool including its last date of calibration, repair and audit, makes compliance to quality management standards more efficient compared to manual-based approaches used in the past. This helps manufacturers meet and maintain ISO 13485 quality management standards, which require organizations to track calibration statuses for measurement devices and ensure that procedures are in place to prevent the use of expired, out of calibration tools. Proactive tool management is a basic ‘shop keeping’ process that pays dividends towards consistently producing and maintaining quality and compliance standards.
Orchestrating quality management from the shop floor to the top floor and providing accurate, and easily-updated work instructions are two of many factors driving the adoption of Manufacturing Execution Systems with medical device manufacturers. Compliance to internal reporting, government and regulatory requirements, and increasingly the customers themselves, are also accelerating the adoption of manufacturing execution systems throughout medical device manufacturing.
Devon Morris is a Sr. Business Development Representative with more than nine years of enterprise software experience. At iBASEt, he engages with complex discrete manufacturing leaders to understand their challenges and strategy for digital manufacturing.