Ensuring Quality and Operational Excellence in Labs

Posted by Romeo Elias on Wed, Sep 19, 2018 @ 09:04 AM

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New technologies are bringing transformation to most industries, especially healthcare. With our health systems going through changes caused by stricter compliance requirements and demands for running at peak performance, the weak links of the system are being identified and eradicated.

The lab environment is no different. We live in the time when increasing efficiency of any operation is the primary goal of creating innovative solutions. These solutions in turn help labs optimize their processes and evolve. However, ensuring quality and Operational Excellence in labs is no easy task, and it should be approached with patience and meticulousness. Here’s how a lab can achieve Operational Excellence and ensure quality:

Improving Accuracy

Inaccuracy in any part of the sample testing process can be a massive problem for labs. Since lab work is done in stages, every stage depends on how accurate was the one preceding it. One of the primary goals of any lab should be to cut down on errors during testing, considering the impact they have on the entire process.

It is also essential for labs to define and implement testing sequences that ensure lab tasks are all completed in the same manner, and at the same time in order. It helps make them more reliable and predictable, which are all attributes that go hand-in-hand with accuracy.

Improving Efficiency

Efficiency is such a broad issue that any area of the lab could have small (or huge) efficiency problems. To weed these issues out, you need to be aware of how all processes are being carried out and then evaluate how successful they are. Some of the usual inefficiency-related problems are wasted motion, overproduction, transportation, waiting, defects, inventory, and over processing.

Fixing these issues requires careful analysis, as well as developing an automated approach that addresses the most common inefficiency problems and neutralizes them. An automated workflow solution can be useful as it helps organizations by clearly showing where the hold-ups in the process are.

Improving Speed

While accuracy and efficiency are essential, speed is the one aspect of achieving Operational Excellence that seals the deal. By developing a streamlined process that ensures logistics are reliable and that specimens are accurately labeled, it’s possible to speed up the process. It helps clinicians begin patient care and treatment faster.

As you level the load and drive flow, you ensure that samples that arrive are tested as quickly as possible. Once you manage to consistently keep work flowing through the lab by leveling workload, and reduce throughput time by doing so, you’ll manage to improve the speed of the entire process.


Managing Quality

Achieving Operational Excellence by improving the efficiency, speed, and accuracy of lab processes has an added benefit of also making them compliant and creating a better quality assurance system. The ultimate goal of a lab when it comes to ensuring quality, as well as Operational Excellence, is to eliminate errors and create a reliable process. It is naturally in line with FDA expectations and best practices of the industry. Using QMS solutions with workflow automation and the ability to work in different modules helps quality assurance and brings it up to OE standard.

With Intellect QMS solutions, your lab can operate on the highest level of speed, efficiency, and accuracy. It ensures you’ll be able to both reach Operational Excellence and maximize quality assurance standards with careful implementation of industry best practices through QMS.

Tags: operational excellence, labs, quality, Quality Management Software, quality data, Quality Management System

Best Risk Management in Laboratories

Posted by Romeo Elias on Wed, Jul 11, 2018 @ 09:32 AM

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In many industries, companies seek to improve their manufacturing and product development and have to go through many regulatory reforms to do so. They require them to adopt quality systems standards which reduce risk.

Clinical laboratories don’t find themselves often in front of similar legal challenges because patients are required to give written consent, and acknowledge that their therapy involves a certain level of clinical risk. Still, risk management in a laboratory environment has become necessary due to the evolution of quality systems requirements. For best risk management in laboratories, consider these practices:

Risk Identification

Testing and quality activities conducted in laboratories have documented vulnerabilities. The most common causes of error are in the pre-preanalytical and post-analytical phases of the testing process.

These include possible errors with order entries, various sample collection errors and inappropriate handling or storage, as well as incorrect interpretation or delayed reaction to laboratory reporting. Laboratories can sometimes struggle to implement even the subtlest changes in policy or practice because it makes the overall performance prone to failures. It’s essential to identify risks in a lab’s testing process and work on preventing them. Laboratories usually deal with this through a traditionally-oriented QC approach, but that’s not always effective.

Quality Management System for Laboratories

Laboratories aren’t free from having to address all aspects of a corporate quality management system. It’s necessary for them to maintain standard operating procedures and implement control measures that can identify potential risks to the system.

ISO 15189 guides laboratories when it comes to technical and quality requirements. Laboratories must be able to record performance data and audit the results of the system, among other things. Correction and prevention of any issues that might arise from using closed-loop processes to document procedures are also paramount.

Risk Management Plan Definition

A risk management plan is crucial for the lab’s quality management plan. Each laboratory can incorporate technical requirements for testing processes into its quality management system differently. Therefore, it’s important to understand how these work to assess the effectiveness of a laboratory approach to risk management. The litmus test for this is the lab’s ability to match its planned objectives to its actual activities. If a laboratory’s execution of its TTP, IQCP or QC plan employs risk-based thinking, that’s a useful approach.

Risk Assessment and Management

In assessing and managing risk, laboratories need to keep track of all the various testing scenarios and outcomes. Once labs can understand their planning and confirm it, they’ll know which measures they need to take to deal with an unwanted result. A risk-management solution that integrates with the lab’s existing QMS could be quite useful. With it, labs could capture, communicate and address all their risk-related documentation and activities. Learning to prevent risk issues is essential. Laboratories need to be able to track risk management issues and manage their risk reporting system efficiently.

Empower your lab staff to make smarter and safer risk-related decisions by using the risk-management software. A standardized system that can fit your unique requirements can be valuable for all aspects of a laboratory’s testing and quality management plan.

Tags: Risk Management, labs, risk identification, laboratory compliance, ISO, iso compliance, risk assessment