Food Industry: Ensuring Quality and Operational Excellence

Posted by Romeo Elias on Thu, Aug 16, 2018 @ 02:41 PM

 

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Striving for Operational Excellence is nothing new to both leaders and followers in the food industry. Still, given the industry’s unique characteristics, finding a way to accomplish it can be a difficult feat for a company.

Any food industry enterprise often finds itself at the mercy of global commodity markets. Once you account for other difficulties such as high demand variability and low margins, it becomes clear why achieving Operational Excellence is a challenge. However, there are ways to ensure both quality and Operational Excellence in the food industry. Here are the things you should keep in mind:

Optimizing Your Manufacturing Process

You can’t achieve Operational Excellence without having a firm hold on your manufacturing process, and that starts with controlling your data. The only way to optimize the process is through data collection and analysis — the more automated this process is, the better. To this end, do away with paper-based systems and digitize them instead. You’ll feel the positive impact of this change throughout your entire organization. There are plenty of benefits to enjoy, from making it easier to demonstrate compliance with quality standards, to being able to trace your metrics a lot more reliably.

Keeping Up with Compliance Standards

With digitizing your enterprise comes the ability to track your implementation of compliance standards. It is important because it gives you some useful insights into how you can improve the quality of your products. It’s always better to address compliance standards early on, instead of running afoul of them and having to correct course. It keeps customers happy and prevents possible financial consequences.

Becoming Able to Save the Day

In case of an unwanted event related to non-conformance to compliance standards, you need to be able to react quickly. Especially in the food industry, any product can become the victim of a quality issue. It leads to costly recalls and damaged brand reputation. To prevent this, you need to be able to catch compliance issues before they become a huge problem. With automated workflows that can manage compliance issues before they escalate, you can avoid the brunt of the blow.

Learning How You Affect the Environment

Another thing that could become a problem is the sustainability costs. If you wish to have a clear picture of how much your operations cost, you can’t forget to include sustainability costs when measuring your KPI. Once you have the data, you can analyze it to see if it’s possible to improve the efficiency of your manufacturing process by reducing some of the costs. Use sustainability information along with your general production data to truly understand its impact.

Implementing Enterprise Systems

The right tools can be of immense help in your quest to achieve Operational Excellence. Use them to create a lasting foundation for conducting all your processes and improving collaboration while breaking down the silos in your organization. Enterprise systems like ERP and QMS can integrate and synchronize all the systems and methods in your organization to create a single, strong value chain.

Here at Intellect, we have an out of the box eQMS solution that can help you do it. Let go of outdated processes and achieve Operational Excellence by driving success with collected data and automation.

Tags: FDA regulations, food industry, mobile compliance, Compliance, manufacturing

3 Compliance Issues That Can Be Solved By Automation

Posted by Romeo Elias on Mon, Jul 16, 2018 @ 01:31 PM

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For compliance managers in any industry, it’s imperative to provide tools and practices for a company-wide commitment to quality. Whether the industry is construction, government, education, healthcare or manufacturing, there are usually plenty of different compliance regulations to meet.

In that kind of a corporate climate, being as efficient as possible at ensuring compliance can be a significant time-saver. Not only that, but efficiency at implementing some of the necessary compliance solutions can ensure that human error has been reduced to a minimum. And in today’s environment of technological advancement, efficiency is often the synonym for automation.

Automating compliance processes is something any company can benefit from, regardless of the industry. Still, automation is beneficial for those organizations that need to comply with ISO and FDA quality standards. Let’s have a look at three compliance issues that can be solved by automation:

Staying on Track with Quality Objectives

Automation of quality management doesn’t only mean that it will be easier to complete compliance and quality management processes in the technical sense. It also helps everyone in the organization be aware of the organization-wide quality objectives. Losing sight of them makes for inconsistent employee performance, and the organization might fail at building a culture around compliance and quality.

Since quality standards and goals are visible to everyone in an automated system, it makes it easier for the employees to meet them. And, in the case of collaboration with external teams, it ensures that the same quality standards will apply to them.

Corrective And Preventive Actions (CAPA)

CAPA is an integral part of any automated QMS, and it’s crucial to staying within compliance standards. In case of any undesirable events, the CAPA can help identify its cause. After that, it’s only a matter of prevention and coming up with a plan that won’t let it happen again. A procedure that helps set everything back on track is necessary. By having an automated solution that handles it, everyone in the organization will be aware of how best to handle any unwanted situation and resolve it quickly.

Document Control

An automated system creates a centralized hub for all organization-related activity. And when it comes to daily functions of an organization, document control is one of the most critical processes. Without a well-organized document control system, you’re inviting chaos into your organization (and most likely inspection as well.) Since FDA-regulated and ISO-certified companies are required to have a document control system, it’s clear to see how problems in this area can affect the whole company. Keeping up with audits and making sure that all necessary documents are created, stored and shared according to the company’s quality standards helps maintain a team that’s more accountable and informed. Therefore, automating document control can significantly improve an organization, not only with compliance but with the day-to-day operation as well.


Today’s business revolves around complex rules and regulations. To ignore any of them is a fatal mistake, but to comply most efficiently, you need a staunch ally. An automated compliance solution that can meet your company’s unique needs could be the difference between success and failure.

With Intellect’s QMS solution, you don’t have to develop your workflow unless you want to customize the existing ones. It works out of the box and makes sure you have an easy time automating your organization’s quality management and compliance processes.

Tags: automated solutions, business automation, workflow automation, iso compliance, laboratory compliance, FDA compliance, mobile compliance, Compliance, CAPA, Document Control

Mobile and FDA Compliance: New Regulations in 2018

Posted by Romeo Elias on Tue, Jun 19, 2018 @ 02:00 PM

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Things change very fast in the world of mobile apps. Besides the mobile phone manufacturers adding better cameras, processors, accelerometers, and gyroscopes; mobile app developers are following those upgrades up with new and improved apps. When talking about mobile medical apps, you probably wondered if the FDA regulates them. The answer has been changing, and we will present some of the latest rules brought by the FDA to make the picture somewhat more transparent.

Groups of Apps Regulated by the FDA

Before you conduct a regulatory assessment, you should determine whether your mobile app is affected by FDA's regulations. The FDA has been evident in their mobile medical app guidance that they intend to use a risk-based approach when applying their rules. Mobile medical apps that could pose a risk to a patient’s safety or health are the only ones the FDA regulates. There are four possible groups of apps, following the FDA’s way of sorting them:

  1. The app is not a medical device,
  2. Even if it is a medical device, the FDA has said that they will not regulate it,
  3. The FDA will regulate because they said that it is an app, and
  4. None of the above.

Apps that fall into groups 1 and two are not regulated by the FDA, while apps from the fourth group are those without analogs in any known examples. Apps from the group 4 are likely to be controlled. It is explained in the FDA’s “Guidance for Industry and Food & Drug Administration Staff” guidance document.

More Challenges with Proving FDA Compliance

The surge of mobile healthcare apps is the surge behind FDA’s regulatory updates and changes in medical app development. According to the Mobile Medical Applications Guidance for Industry and Food & Drug Administration Staff guidance, a medical app is considered to be an app that works as an accessory to transform a mobile medical platform for a form of medical use or augment, supplement, or support an existing medical device. To ensure the effectiveness and safety of medical apps, the FDA will use the same risk-based approach that it uses for other medical devices.

The Emergence of the De Novo Pathway Trend

PMA (Premarket Approval and 510(k) pathways for putting a product on the market have been more popular than De Novo pathway, but this is changing. It is happening because the FDA is streamlining the application process without requiring a 510(k) anymore. What De Novo method provides is a way to classify new medical devices as Class I or II when there’s no predicate device. If a person believes that their medical device is appropriate for classification into these two Classes, they can submit a de novo request without preceding NSE and 510(k). The De Novo pathway is highly risk-based, which means that you can get a product on the market without a lengthy premarket approval application (PMA.) It is only if your new technology isn’t considered high risk and you’re able to demonstrate how all known risks can be mitigated.

New and innovative ways for health improvement and better health care delivery are being opened with the widespread use and adoption of mobile technologies. The FDA is there to encourage mobile medical app development and has a responsibility to oversee their effectiveness and safety. If you’re conducting a digital transformation to be FDA compliant with all new regulations and laws, involve your compliance team to ensure alignment from the beginning.

 

Tags: mobile apps, mobile applications, mobile compliance, FDA, FDA compliance, Regulations, FDA regulations, new regulations