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

4 Steps to Achieve Workflow Compliance

Posted by Romeo Elias on Thu, Apr 19, 2018 @ 11:29 AM

 

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All companies, regardless of industry, are responsible for ensuring that their policies and processes are designed to comply with applicable laws and regulations. Because of the complexities of regulations and requirements, many companies struggle to secure compliance.

Companies who compliment their efforts with technology have found that staying compliant has become far less challenging. In the past, businesses had no choice but to rely on Excel sheets and Word docs to keep track of all their people and processes. It meant exchanging numerous emails and risking communications getting lost. Innovative software means the end to duplicate reporting and copying data repeatedly.

These centralized technology tools meant having confidence in your compliance and meeting regulatory requirements. Compliance workflow automation gives you the ability to audit multiple tasks into one process and schedule these processes to run on a regular basis automatically.

While the technology has been revolutionary, it still doesn’t relieve compliance teams of monitoring people, processes, and anyone else who must meet compliance obligations.

One of the crucial steps to ensuring compliance is streamlining workflows to ensure that only employees who should have access to specific data have relevant access. The purpose of a workflow is to divide processes into smaller steps which are passed to different people with the company.

Because of the multiple exchange of hands in documents, there could be numerous submissions for review and need for amendments. All the necessary steps should be taken into account and control processes must be enforced, and verification of information should be ensured.

Here are some tips track and monitor workflows to ensure that they achieve compliance, and nothing is overlooked or goes missing:

1. Identify Legal Obligations

What are all the compliance obligations and how do they impact your business? Once you have identified what these are, interpret them into specific compliance requirement statements.

Each of these requirements should be organized according to underlying regulations and codes along with common requirements such as policy development and monitoring requirements.

2. List All Parties Subject to Audits

List everyone who will be held responsible for meeting compliance obligations; this includes people, vendors, 3rd parties, sites, and processes. Because this will likely be a comprehensive list, be sure to organize them in department folders.

3. Evaluate Level of Risk

It’s impossible to monitor every aspect of your business at all times; instead of attempting to do so, focus your attention on where risk is highest. Identify who you would consider as compliance risks to your business based on criteria that evaluate the levels of risk.

4. Determine of Level of Attention

Set up your system to conduct audits regularly. Audit frequency should be established based on the level of risk. For obvious reasons, high-risk people, processes, and parties should be audited more frequently than those that are considered as low-level risks.

While the right software can help you achieve workflow compliance, the reality is that your employees are the risk that you will have the least control over. To become fully compliant, it’s important to not only streamline your processes and systems but also regularly review your people.

 

 

Tags: digital transformation, quality data, Compliance, Workflow, Workflow Managment, Workflow and Business Process Management, workflow automation, legal, Audits, Risk Management, risks

Benefits of Access: Capturing Quality Data on Manufacturing Mobile Apps

Posted by Romeo Elias on Wed, Mar 07, 2018 @ 09:33 AM

 

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The ability to use mobile devices on factory floors and laboratories is transforming many aspects of manufacturing in highly-regulated manufacturing industries such as pharmaceutical, nutrition, and medical.

Regarding healthcare, mobile devices have become so common that there’s been rapid growth in the development of medical software apps. These apps assist health care professionals in communications and consulting, data and time management, health record maintenance and access, patient monitoring, education and training, and even clinical decision-making.

Many manufacturing companies have seen how mobile devices have revolutionized the healthcare industry and are now also leveraging mobile technology with the intent to use them increasingly in the monitoring of production and to ensure factory efficiency and safety.

In the past, computing and communications meant having to rely on multiple devices which included pagers, PDAs, and cellphones that could only make and receive calls. With today’s smartphones, you have all the capabilities of those electronics in one device. But beyond the ability to make voice calls and send texts, today’s smartphones and tablets have browsers, GPS, sound recorders, and high-quality cameras. And most importantly, access to industry-specific apps.

With smartphones and tablets, you can now capture data and get quality assistance from ultimately anywhere. The ability to capture everything from deviations during sampling and testing to calculating batch measurements in real-time means that non-conformance and corrective actions can be enforced almost immediately. Also, having offline capability to still capture data on mobile if there is no internet connection can help with situations where the factory floor doesn’t have good reception on the mobile device.

In manufacturing, the significant benefits of allowing workers to bring their mobile devices to the floor are giving them the ability to contact other employees, communicate with off-site personnel, and reference manufacturers’ documents. With mobile technologies, there is a significant improvement in logistics and supply chain coordination with suppliers. Customer responsiveness is enhanced thanks to the capability to integrate mobile CRM systems with order management, pricing, and fulfillment.

This improvement in efficiency is saving manufacturers significant sums of money each year. It may seem trivial when you think about how the reduction in time wasted between capturing the information and relaying it to the relevant people is a matter of minutes. However, consider how much valuable time is lost every year when you add up all those lost minutes that ultimately equate to hours, days, and weeks of misspent time. This could have easily been avoided if everyone was equipped with a mobile device that allows them to deliver up-to-the-minute data.

Factory environments are also becoming increasingly safer as workers have access to relevant and real-time data which traditionally, was confined to a desktop in the control room. Access to real-time adjustments and improvement in supplier traceability of critical materials means having the most accurate information, ensuring extra levels of safety and enhancement in quality levels.

Highly-regulated manufacturing industries such as medical products need to be constantly calibrated. With mobile-based sensors, data is captured and reported in real-time to production, allowing quality engineering teams to immediately act and ensure the floor is continuously in compliance.

Thanks to these realizations, manufacturing landscape is changing and CEOs are embracing digital transformation, prioritizing the importance of mobile technologies in the form of mobile apps and integrating them in their strategies, procedures, and processes to increase accuracy and speed to production centers. The goal is to deliver better communication, promote collaboration, and increase responsiveness to deadlines and delivery dates.

 

Tags: mobile apps, mobile applications, quality, quality data, mobile web, Quality Management Software, QMS, Quality Management System