Handle with Care: Five Steps to Achieve More Efficient Specimen Management Quality Control

In 2016, U.S.A. regulators made changes to ISO 13485:2016, which is a standard for managing quality in the medical industry. These changes aimed to align differing jurisdictional product development and distribution guidelines, but add new process-based decision making and risk management checkpoints across medical supply chains and product lifecycles.

This change gave medical companies three years to follow the new rules and show they were following them by February 28, 2019. BioTouch (previously Path-Tec) welcomed the opportunity and became one of the first specimen management providers to achieve ISO 13485:2016 compliance certification. By setting the industry standard, we validated that its testing kits are produced and delivered to labs at full integrity and optimal quality.

This deadline is a chance for other medical companies to look at their quality control and make it better. Even if they don't have to, companies should improve how they manage quality to meet customers' needs better.

Improving quality control doesn't have to mean big changes or lots of money. Here are five things to think about to improve how you control quality:

1. Delegate Clear Roles: Give each person on your team a specific job to do. Quality Management compliance is no different. Organizations should appoint individual team members to specific roles in the improvement execution process and delegate tasks accordingly.
   
   For instance, Quality Managers and Quality Supervisors should oversee product quality maintenance throughout the entire cycle. They should work closely with, but not override, Quality Control Inspectors, whose job is to review all products and procedures and note potential inaccuracies or inconsistencies. Additionally, businesses should consider streamlining ISO consultation to a single, centralized partner, rather than having individual ISO consultants at each operational location.
2. Defined Processes: Make clear rules for how products are made and checked. Everyone should understand these rules and have access to them. This makes sure things get done right and products are handled properly.
3. Better Identification: Each product should have a unique code or label so you can track it from start to finish. Teams should assign unique identifiers to finished products, along with manufacturer, internal and customer part numbers which can take the shape of reject tags, acceptance labels or work order numbers. This helps you see who worked on each product and make decisions about staffing and production.
4. Thorough Inspections: Check every product carefully before using it. In a fully compliant, quality controlled medical environment, no product should be processed or used until it has undergone a thorough inspection. While it can be easy to move materials forward to maintain a fast-paced workflow, the long-term risks of doing so far outweigh the short-term benefits.
   
   As part of their general procedural review and improvement, medical businesses should establish clear “pass/fail” guidelines for incoming products. Unless a particular item meets all authorized documentation, it should be isolated and processed separately. This extra diligence will prevent potentially defective supplies from entering the field, and ensure that medical procedures move forward without compromise.
5. Get Feedback / Ask for an External Assessment: It is recommended, for businesses to request external perspective and gauge the efficiency and security of their operational strategies. Talk to your customers and ask them what they think about your products. This valuable process helps you find problems early and fix them before they get worse.
   
   For added validation, medical businesses also should consider bringing in a third-party Quality Management auditor. These individuals or teams can check adherence to required customer and/or regulatory requirements without bias, and identify gaps that internal teams may otherwise overlook.

Following these steps can help you improve your quality control and make your business better. In the medical industry, good quality control not only makes customers happy but also keeps people safe. So, take these simple steps to make sure your business does well for everyone involved.