Best Risk Management Practices For The Food Industry

Posted by Romeo Elias on Wed, May 09, 2018 @ 10:27 AM

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To ensure quality and safety, it’s critical for the food industry to manage and track non-conformances that can lead to product defects and disastrous mistakes.

Risk Management tools and practices were specifically developed to protect against these food safety dangers. By leveraging them, the food industry can protect itself from the risk of a lawsuit, accident, deliberate acts, and even acts of nature.

From supply chain to food health, the food industry cannot be entirely free from internal failure or external events that can threaten productivity and safety. However, having risk management practices in place puts you in a better position to protect yourself from the risks your business is exposed to every day.

If you want your food business to be profitable, you need to pay close attention to all the details; this includes everything from ingredients to equipment to your workforce; most importantly, it involves focusing on defining processes and policies. Here are some best practices in risk management:

Identify Responsible Parties

The key to managing risk is to identify all parties that are involved. It’s critical to understand who is accountable for food safety risk, quality, and compliance. 

When it comes to minimizing risks with manufacturing foods, everyone should recognize that it is a responsibility shared across all levels; this involves plant managers, quality, and food safety group, corporate supply chain, operations staff, QA personnel, and your maintenance crew.

Your QA personnel plays a significant role at all stages of production, making them critical to your overall risk management plan. Without diligence in documenting areas of high risk and communicating concerns to relevant stakeholders, risk cannot be mitigated.

Prepare Employees with Thorough and Continuous Training

Your employees handle day-to-day processes; therefore, risks start with your people. To lessen the possibility of devastating situations, your team should be properly trained in equipment handling, customer service, and safety procedures. Ensure they’re across on employee health codes that outline employee hygiene, inspections, regulated equipment, and even which cleaners are acceptable to use on facilities and surfaces.

While equipment may seem self-explanatory, it would surprise you how many times the wrong assumptions on how to operate equipment has led to disastrous accidents. To boost compliance, train employees how to properly handle all equipment. Thoroughly explain safety protocols that include proper handling, storage, and preparation of food items.

Leverage Technology 

Empower staff with food safety software that complements your overall risk management efforts. Visibility, communication, and compliance can all be improved by using the right solutions.

Communication is crucial. Without it, contamination risks may not be addressed immediately. Safety and quality are all put at risk when there is a breakdown in the exchange of information, leading to dangerous consequences.

With the right food safety and risk management software, you can establish a safety plan that meets FDA Food Safety Modernization Act (FSMA) compliance requirements and optimize operations by standardizing practices and eliminating duplication of documentation. You can increase productivity by automating manual processes that are repetitive and slow down productivity. And because you have access to historical data, you can analyze and predict trends and identify risks.

 

Tags: risks, food industry, Risk Management, regulatory, Regulations, business process

Benefits of an Automated Digitized Solution for Document Control to Help Meet ISO and FDA Regulations

Posted by Romeo Elias on Mon, Feb 12, 2018 @ 11:56 AM

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Why do people cringe at the very thought of compliance and change? Perhaps it’s because compliance means having to behave according to someone else’s command, and it’s our natural reflex to be resistant to being controlled, and skeptical of change.

But what if our reluctance to change was causing our organizations to lose massive amounts of money due to inadequacies caused by outdated processes?

The loss of revenue that occurs when document control systems are inefficient can be significant, and can cost manufacturers millions of dollars. These inefficiencies can be traced to the use of paper/hybrid-electronic systems which partially involve a manual approach or the combination of both digital and paper files. As with any manual approach, this was prone to error which resulted in delays.

And for this reason, FDA-regulated and ISO-certified companies mandated with a document change control system have shifted to automated digitized solutions which eliminate the laborious and time-consuming manual management of documents.

Here are the main benefits of an automated digitized solution for document control and how it helps ensure companies meet ISO and FDA regulations:

Easy Creation of Various Types of Documents

An automated digitized solution simplifies document creation. Different document types mean handling each document differently and may consist of separate approvers and workflows. An automated solution simplifies the creation and approval of documents, assigning the correct workflow based on each document's unique routing.

Faster Review and Approval

It’s up to the system to route documents to be reviewed by the relevant employees, ensuring final approval is received on all documents before they are used and distributed. Automated digitized solutions

have intelligent business rules that make room for deviations in the process when necessary.

Employee Training Integration

When the Training Management system is integrated with a document control system, companies can easily define which employee needs training on each document. The systems updates training records, allows self-training, and automatically updates employee status when training has been completed.

Promotes Collaboration Through Visible Reporting

When the reporting system is integrated with good document control, employees can quickly and effectively look at data to run the necessary reports. Visibility allows employees to look at data and keep business processes consistent and controlled.

Keep Data Secure Through Intuitive Filtering

A centralized system doesn’t mean that all users should be granted access. For security reasons, employees should only have the appropriate access to documents needed for them to approve, review, and make any necessary changes. A document control system allows you to filter and secure data thus limiting visibility data to only what is relevant to each user.

In conclusion, document control systems are put in place to ensure manufacturers are building products that are reliable and safe. ISO and FDA regulations are enforced to ensure that both process and documentation follow pre-approved methods.

For a company to thrive, it needs to recognize that compliance is a necessary tool that will give it a competitive edge. Achieving and maintaining compliance ultimately leads to efficiency and better output. Having an automated digitized solution helps you achieve all that by eliminating manual processes that are prone to error, giving your ability to filter access, automate redundant processes, and ensuring the correct routing and workflows.

Tags: Document Control, FDA, ISO, regulatory, Regulations, automated solutions, Business Automaton

Software Compliance in Life Science Product Industries

Posted by Romeo Elias on Mon, Jan 08, 2018 @ 02:58 PM

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Operating a business in a government-regulated environment carries a high expectation of compliance and strict adherence to guidelines and policies. For companies that operate in the hyper-regulated scope of the Food and Drug Administration, software compliance is a top priority that must meet rigorously enforced standards.

There is no room for error in either medical or pharmaceutical software applications. The greatest concerns in each area focus on electronic recordkeeping and signatures (ERES) as mandated by Title 21 Part 11 of the Code of Federal Regulations.

 

WHO MUST COMPLY

Part 11 compliance applies primarily to medical device manufacturers and pharmaceutical companies. However, business operating in any of a number of life science product related industries must also ensure software compliance:

● Biotech and nanoscience companies

● Biologic and other drug developers

● Some cosmetic company applications

● Contract research organizations

There are few exceptions, but generally speaking, any company involved in the research, development, manufacture, or distribution of an FDA regulated product must be operating ERES software that complies with Part 11 guidelines.

 

FOCUSED ON RELIABILITY

Prior to cloud origination, digital conversion, and full-software integration, FDA regulated companies stored and submitted records in paper form. Hard-copy records carried a certain degree of reliability and trustworthiness necessary in the closely watched industry of medical and pharmaceutical development.

As technology advances, so have storage solutions and records. It is no longer efficient or economical to maintain volumes of paper when digital storage and filing are industry-wide norms. Twenty years ago, the FDA implemented Part 11 as part of an effort to standardize and regulate the quality, reliability, and trustworthiness of non-paper records, signatures, and filings with the agency.

Since the implementation of Part 11, software regulations have become an integral part of compliance issues and guidelines. When any company generates reports and signs off electronically, and submits digital documents to the FDA, it must comply with Part 11 regulations. Any software application used in the process must meet strict requirements.

 

SOFTWARE REQUIREMENTS

The FDA mandates a wide-range of complex and technical software requirements that individual companies must meet to comply with Part 11 rules. Since the accuracy and reliability of ERES data is the key focus of FDA concerns, software must include:

● Some validation process to ensure accuracy and identify altered or invalid records

● The ability to generate complete copies in various forms

● Security controls to limit access to authorized users

● Long-term storage and retrieval

● Appropriate training and tracking of electronic signature use

● Time and date stamped audit trails

In addition to these compliance requirements, companies must also have written policies regarding the use, control, and authorization of ERES systems among other strictly applied security and authenticity issues.

As technologies change and become obsolete more quickly, companies experience regular software issues and compliance questions. When evaluating software compliance, a good rule of thumb is for companies to exercise Part 11 software practices in any instance where records meet Part 11 definitions.

If your company’s software is out of date, lacks security and verification assurances, or has other compliance issues, it is time to find a solution. Ensure your company’s systems meet the latest Part 11 iterations and do not risk FDA sanctions because of a failed software audit.

Tags: FDA, regulatory, quality, validation, Compliance, Quality Management Software, QMS

Managed Workflow Equals Quality

Posted by Romeo Elias on Tue, Jan 02, 2018 @ 12:43 PM

 

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Managing workflow in any business or industry can be like trying to tame an octopus with its many tentacles, especially in today’s tech-centric production lines. However, effective workflow management and planning can do more than lead to efficiency and cost savings. It can also increase the success of data gathering and analysis in across the board quality management systems including CAPA and Document Control.

By keeping the right people in the loop and informed though a transition to digital workflow, your management team can improve information sharing and communication. Effective workflow management stems from a variety of practices and technological inclusions that replace older practices not designed to keep up with today’s rapidly changing business environments.

Get Back On Track Quickly

No business functions without quality and improvement. Systems like CAPA and Document Control benefit from improved workflow because information is disseminated, returned, and processed more quickly and accurately. When CAPA practices detect a regulatory anomaly on a pharmaceutical or medical device production line, efficient workflow enables a rapid correction to ensure a near instantaneous return to compliance.

Efficient workflow management reduces communication discrepancies and lags that may lead to production disruptions. When companies increase the reliability of delivered information and corrective planning and action, they reduce down time and the traditional non-digital evaluation period between a business process interruption and return to service.

Communicate Effectively with Team Members

One obstacle facing production businesses, especially those operating in remote and multiple sites, is ensuring that all team members have the latest and most accurate information regarding a company goal, directive, case management, or other time-sensitive communication. Information delivery provides feedback that leads to productivity, solutions, and drives quality control and customer satisfaction. A lack of shared information results in policy and procedural breakdowns that impair quality output and other business processes.

With employees working off-site, separate from management and quality control teams, the simultaneous delivery of information and management decisions ensures that your entire team functions as a unit. Some examples of synchronized information delivery accomplished through increased workflow management include:

  • Regulatory issues and updates
  • Workload assignments
  • Customer feedback
  • Task notices and deadlines adjustments

When every member of your team receives the same information, it eliminates the occasional system-wide hiccups that interrupt quality management, production, and output. Synchronized digital delivery eliminates the redundancy of paper copies and the need to file documents at a number of locations and offices when a single cloud-based alternative serves multiple recipients.

Keep Teams on the Same Digital Page

When a business relies on compliance and regulatory issues — such as FDA directives codified at the ubiquitous 21 CFR — every member of the quality control team needs the same up-to-date information at their fingertips. Communication among management personnel relies on integrated and autonomous workflow that includes delivery to key personnel who are aware of assigned tasks and problem solving procedures.

Effective business process management demands on-the-fly delivery, communication, and tasking. When a quality issue arises, you cannot afford to have team members thumbing through outdated manuals and regulations or not knowing their position in the QMS flow.

For businesses focused on strict regulatory compliance to critical standards, workflow management assures heightened responsiveness and effective quality performance. Eliminate lag times, outdated documents, and interactive missteps with an out-of-the-box QMS solution that incorporates workflow in both CAPA and Document Control modules. Should you wish to develop your workflow by customizing these modules or creating new ones, this is an ideal solution for your business.

Tags: Workflow, QMS, Hosted Workflow, quality, Quality Management System, Quality Management Software, Workflow Managment, Workflow and Business Process Management, Workflow Process Management, workflow automation, CAPA, Regulations, regulatory, Compliance, Customer Complaints, FDA, Document Control