Beyond CAPA: Using Risk Assessment to Streamline your Quality System
No matter the scope or severity, CAPA is the ultimate catchall for events in the system. This becomes a problem when the "critical" CAPAs - those events that have the most impact on the business as a whole, become lost in the pile, hidden among non-critical, immediately correctible events, and virtually invisible to the enterprise.
The Convergence of Environmental Health & Safety and Quality Management Systems
Many businesses are reevaluating their current technology portfolio, seeking ways to integrate and consolidate systems and solutions to streamline operations, while maximizing return on investment. One such convergence that is gaining traction is that of Quality Management and Environmental Health and Safety Systems.
Creating Harmonized Food Safety Processes through Integration
The Food and Beverage industry is increasingly adapting the Global Food Safety Initiative (GFSI) as its “stamp” of high quality and safety. In fact, many leading organizations today will only work with GFSI-compliant suppliers. The GFSI-benchmarked food safety schemes—SQF, BRC and IFS for example—are driving organizations to seek methods of enhancing visibility into their quality and safety operations.
Enhancing Collaboration with the FDA through eMDR
The Food and Drug Administration (FDA) is tasked with the job of ensuring that all products produced within medical device, food and beverage, pharmaceuticals, biologics, and all other industries are produced safely and effectively. As market demand increases for the need of quick product cycles and the distribution of regulated products, the ability to react quickly to an adverse event must be considered.
Extending Food Safety down the Supply Chain: Incorporating Suppliers into Your Quality Process
Suppliers within any industry play an important role in bringing products to market. Companies rely on and trust their suppliers to provide them with the ingredients needed to properly manufacture their products and meet the pressures of keeping up with industry demand. However, in today's demanding food chain, there is an ever-increasing level of complexity to supply chain management.
Food Safety, from Farm to Fork: A Best-Practice Approach to Implementing a Food Safety Management System
Now, more than ever, all food chain stakeholders are required to demonstrate their commitment to food safety and quality. This paper will describe how automating an FSMS will streamline processes and procedures related to HACCP, ISO 22000, and SQF—ensuring compliance to regulations in the food and beverage industry.
Global Harmonization: Promoting Consistency Throughout the Enterprise
As organizations vary from site to site, they work toward the common goal of producing a high quality product. But as larger corporations grow, individual sites tend to deviate in corporate-mandated processes. With these deviations adding up, eventually there will be too much diversity across these individual sites, resulting in disconnected processes from one site to the next.
How the Food and Beverage Industry can utilize a QMS’s Recall Management Tool to Improve Efficiency in the Recall Processes
In the Food and Beverage industry, brand equity is imperative to an organization’s success. During the past few years, there has been an increase in publicity surrounding recalls of products such as peanut butter, spinach, and pet food. Measures must be put in place to effectively mitigate the risk of a recall, or in the event that a recall is necessary, manage the process as quickly and efficiently as possible.
Improving Efficiency in the Recall Process by using a Quality Management System
Having to conduct a recall is one of the most trying experiences in any organization mandated by the Food and Drug Administration (FDA). If it is determined that a recall is the only available course of action, it is imperative for an organization to have a system in place to guide them through the recall process from beginning to end, ensuring it is completed as quickly and efficiently as possible and nothing is left out of the quality loop.
An Insider's Guide to Selecting an Environmental Health and Safety Management Software System
In today's dynamic and demand-driven market, the need to implement enterprise technology to keep pace with rapidly evolving operational, production and compliance environments is key to success. With a high demand and a large vendor landscape, it sometimes becomes difficult to discern which systems provide the greatest value and guarantee a successful implementation.
An Insider's Guide to Selecting a Quality Management Software System
As demand for Quality Management solutions grow, so does the vendor landscape - more software vendors are providing solutions for Quality and Compliance Management than ever before. With a high demand and a large vendor landscape, it sometimes becomes difficult to discern which systems provide the greatest value and guarantee a successful implementation.
An Integrated Approach to Air Safety: Integrated Airline Management for the Airline Industry
Airlines face numerous compliance challenges, including complying with regulations and initiatives set forth by the International Air Transport Association (IATA), and regulatory bodies. With all of the compliance pressures occurring within the airline industry, whether it is safety; environmental; quality; or financial, there has become an urgent need for an Integrated Airline Management System (IAMS).
Integration Management Connects Key Business Systems to Quality: Making the Case for Increasing Visibility into Status of Quality within the Enterprise
In today's business environment, information silos are created, whereby data across all systems is disconnected or redundant, and communication is hampered between departments. The ability to transcend these silos and create a seamless environment whereby all related business systems collaborate and share information is a growing challenge in today's business climate.
Keeping up with the New Pace of Business: How Risk Management Tools can Improve Product Quality in Today’s Rapid Lifecycles
With the product lifecycle moving so fast, many organizations may ask the question, "how can we effectively measure quality?" What can an organization do to keep up with this new pace of business while ensuring the visibility that quality deserves? The answer is Risk Management.
Localization: Streamlining Communications Across Continents
With organizations sharing knowledge and information across these global enterprises, it is important to effectively translate all aspects of the software to ensure that communication is harmonized throughout the organization. Localization technology makes this possible. In order for a system to be properly localized, it needs to be translated completely.
Managing your Risk Has its Rewards: Making the Case for Risk Assessment in Streamlining your Quality and Compliance Processes
In today's Quality Management systems, the ability to control and correct processes is key to maintaining a high level of compliance within an organization, and in many cases, the ability to discern the overall impact of events is a subjective determination, which can result in major errors and affect the overall compliance within an organization, and possibly lead to increased legal liability.
Not all SaaS Solutions are Created Equal:
Determining Which SaaS Model is the Best Fit for Your Company
Today’s software systems have undergone a major evolution in how they are delivered to the customer. Customers now have options when it comes to software deployment— on premises or on demand. On demand, or more commonly known as Software as a Service (SaaS), is leveling the playing field by making enterprise software more accessible to organizations that previously could not afford to implement on premises.
Pharmaceutical Compliance that Spans the Supply Chain: Considerations for Extending the Quality System Beyond Your Enterprise
Today's rise in globalization means that the pharmaceutical market is operating on a grander scale than ever before. Pharmaceutical organizations typically extend manufacturing to suppliers or contract manufacturers, who directly affect the quality of the product. These suppliers are located around the world—globalization has eradicated distance and time zones and has unified the pharmaceutical market. However, for suppliers to effectively operate within this global environment, harmonization is needed.
Quality Management and Change Management: Ensuring a Change for the Better
Change, as the saying goes, is the only constant. This also applies to changes to product or process. Regardless of industry—whether automotive, medical, or food for example—there eventually comes a need for change. Inevitably, an organization will need to change a process or product at some point in its lifecycle in order to keep up with growing market demand and to keep pace with the competition. The process leading up to change execution is always complicated and needs to be managed properly in order to result in an effective outcome.
Risk Management and its Effect on the Environmental Health and Safety System
In the EHS industry, there is a focus on reducing job-related incidents, in order to promote a safer workforce and to maintain compliance with regulatory agencies. Tackling issues before they have a chance to arise and spread throughout the enterprise helps to ensure that potential events are stopped before they begin. Risk Management is one of the methods for mitigating adverse events.
Taking Quality Outside Your Four Walls: An Integrated Approach to Supplier Quality Management
Lack of visibility of quality into the supply-chain can often have an adverse effect on the business, leading to poor quality of product, lost inventory due to quality issues, or even stock-outs of particular product lines. How can companies streamline their supplier quality management to increase visibility into the supply-chain, and incorporate their quality standards and practices down the supply-chain?
Uncovering the Hidden Factory by Integrating your Systems
There is a mysterious, secret hidden factory lurking in your organization, but don't go searching in the plant to find it. This factory is hidden because there is a lack of communication between your Enterprise Resource Planning system or Manufacturing Execution System, which is tracking nonconforming materials and your Quality Management System, which is tracking the corrective action of the process behind these nonconformances.