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First FSMA rules in effect July 3. Are you ready?

by Paul Leavoy Friday, May 06, 2011

Earlier this week the U.S. Food and Drug Administration (FDA) announced the first set of rules under the landmark Food Safety Modernization Act (FSMA), legislation signed earlier this year which gives the FDA sweeping powers to prevent food safety disasters.

The two new rules, which take effect July 3, are pretty logical preventive measures that, in all fairness, probably should have been implemented a long time ago. The new rules are as follows:

  • Order on Administration Detention of Food: The first new rule gives the FDA the authority to hold food products that may be contaminated or mislabeled. Before now, the administration only had the right to detain food when it had sufficient evidence it was mislabeled or contaminated, thereby presenting a threat to humans or animals. Now if the FDA even suspects contamination or mislabeling, it can detain the product.
  • Rule on Imported Food:  Organizations importing food now have to disclose whether another country has rejected or refused the product. With this information, the FDA will be better equipped to target foods that may pose a risk to public health.

The new regulations are the first in what will be an ongoing stream of new rules determining how the FSMA affects organizations across the U.S., but also adds to the Act’s current scope, which includes legislative components that took affect earlier this year when it was signed into law, including the following:

  • If the FDA determines a reasonable probability of serious adverse health consequences in any food product, it may demand records of other food products affected in a similar manner.
  • If the FDA finds a “reasonable probability” food has been misbranded, adulterated, or capable of generating serious adverse health consequences, it may issue a mandatory recall.
  • Whistleblowers who report violations or testify benefit from increased protection from any form of reprisal.
  • The FDA has already increased the frequency of inspections and also uses a risk-based model to prioritize inspections.

As more FSMA rules are come down the pipes in the next 12 months, and as the new requirements take effect July 3, it is up to all U.S. Food and Beverage businesses to take action now, by implementing food safety management systems, documenting detailed food safety plans, focusing on companywide hazard identification and risk mitigation (along the lines spelled out in HACCP), and prepare for a higher frequency of inspection.

 

Quality Management | Supplier Management

Milk ain’t oil: EPA sides with common sense

by Paul Leavoy Tuesday, April 19, 2011

Yes, the line’s been used a hundred times in the past few days, but warrants repeating: U.S. dairy farmers needn't cry over spilled milk any longer.

Beneath the sound and fury of political arguments over the Environmental Protection Agency’s (EPA) right (nay, duty) to regulate greenhouse gases, the agency quietly sided last week with milk producers and finally exempted milk from oil spill control regulations.

The EPA has long required shippers of oil tanks and containers to develop spill control and prevention plans. Problem was, this included dairy farmers, since milk is defined as oil under the Clean Water Act because it contains animal fat (an oil). The regulations were originally designed for Big Oil, not farmers, but it has taken a few years for the agency to exempt dairy from the Act’s requirements. With the final ruling, milk, milk product containers, and milk production equipment are exempt from Clean Water Act shipping and container requirements, effective immediately.

Some estimates peg the savings from the move at nearly $150 million for U.S. milk and dairy farmers.

Unfortunately, critics of the EPA have used the episode to underscore the perceived futility of the organization, apparently forgetting that it is keeping them safe from irradiated food products, among other things.

 

Environmental Management | Supplier Management

Planning for the unforeseeable through supplier evaluation

by Paul Leavoy Monday, April 18, 2011

Having the flexibility to identify, contain, and adapt to foreseeable and unforeseeable issues is critical to a comprehensive response plan for quality nonconformances and product recalls. Proactive, responsible companies that implement comprehensive vendor/supplier/contract manufacturer evaluation programs and performance tracking systems as components of an overall quality management system (QMS) will boost preparedness and ensure smooth responses to otherwise devastating product recall scenarios.

Any business — large companies especially — should select contract manufacturers in the same way they select suppliers and other vendors: with thorough research, hand-on inspection and rigorous screening.

A good way to think of it is this: Treat suppliers, vendors and contract manufacturers as if they are your own facilities. Even if they are not providing you with an end-user product, if your company name is going to be on the final product, your customers will view you as responsible and you will be ultimately accountable for the defect.

The alternative – basic adherence to minimal regulatory requirements – does not constitute the wisest PR and quality assurance philosophy. Recall that five years ago, a nationwide recall on children’s toys containing lead paint—and manufactured in China—cast a pall on the integrity of the country’s quality standards. It also forced American toy giant Mattel to recall more than 18 million products and face significant brand damage.

Even entrenched brand images can be dealt significant blows by product recalls, especially when those recalls affect the lives and health of children. For quality managers at companies that rely on contract manufacturers and suppliers overseas, such situations are a call to action: a proactive corporate ethos on quality management — and supply chain traceability in particular — will not only save time and costs long term, it will ensure products exceed minimal regulatory requirements and avert potential public relations and brand image crises. A comprehensive QMS that enables enhanced supply chain traceability and supplier relationship management is the hallmark of such an approach and will inevitably save costs in the long run.

ISO 9001 | Quality Management | Supplier Management

The advantage of web-based supplier management

by Paul Leavoy Thursday, March 17, 2011

While a supplier management system can be implemented without software, the benefits of establishing a software-based system are numerous and significant. Depending on how comprehensive the solution is, a software-based system can be capable of providing real-time metrics that can be accessed instantly with the click of a button, thus rendering an entire supply chain and vendor base transparent. Some critical features of a comprehensive software-based supplier management system include:

Supplier management and evaluation

The system should be able to register and categorize suppliers by company name, supplier number and performance rating as well as other details in a centralized portal. The system should use this information to schedule, notify, and archive all supplier evaluation activities and results and develop a consistent supplier rating program with customizable surveys.

Risk management and continuous improvement

To avoid quality issues and ensure all elements of the supply chain run at peak performance, the supplier management system should be capable of:

  • Tracking supplier non-conformances and all details associated with those non-conformances.
  • Specifying target investigation dates or target response dates and manage all investigation related data.
  • Implementing corrective actions and measure their effectives over time.
  • Reporting on and analyzing root causes.

Streamlining workflow

To take the time and energy out of micromanaging data and issuing notifications, the system should be capable of streamlining supplier management workflow by tracking all supplier and vendor data in a central portal that’s accessible across the organization. A proactive system should also be capable of sending automated email notifications on pending and overdue supplier tasks to employees and their supervisors.

Real-time visibility and reporting

An ideal system should be capable of monitoring, reporting on and storing data on each stage of the process, including initial vendor registration and setup, ongoing supplier performance assessments, the implementation of corrective and preventive actions and evaluations on the success of those actions. Employees with access to the system should be able to instantly update information and generate ad hoc, boardroom quality supplier management reports on root causes, correction actions, and authorize claim amounts based on real-time data.

Some key requirements

A web-based supplier management system should be:

  • Accessible from multiple locations around the world under stringent security protocols.
  • User-friendly and intuitive, thereby increasing user adoption and reducing training and support costs.
  • Easily configurable to address company-specific requirements and metrics (initial and ongoing).
  • Scalable, allowing an organization to roll out the system to key suppliers.

Learn more about supplier management optimization strategies and tactics by checking out Intelex's Optimizing Supplier Performance white paper, or by giving us a call to discuss our supplier management solutions.

Quality Management | Supplier Management

Recognizing excellence key to boosting supply chain performance

by Paul Leavoy Wednesday, September 01, 2010

In business, attracting and retaining customers is of paramount importance. Customers need attention, respect, and a whole lotta love.

However, it is important to remember that any business relationship is a two-way street: just as you have customers, you’re probably a customer yourself. Of course you have the right to demand the highest level of product and service quality from every member of your supply chain and vendor base. But it is also important to cultivate lasting and mutually respectful relationships with the suppliers you prize the most.

Performance improvement motivation is a great way to ensure you receive the very best from your suppliers. It can be as simple as rewarding suppliers who exceed expectations (determined by implementing a supplier rating program).

It’s not tough to reward suppliers, but few organizations actually go out of their way to recognize stellar performance. A supplier awards program is not a resource-intensive project, but the results can be substantial.

Here’s a few different ways your organization can reward a supplier for consistent, high-quality performance:

  • Publicity: Issue a press release acknowledging a supplier’s performance excellence or even any news affecting the supplier alone or your business relationship.
  • Recognition: Hold a supplier awards reception and acknowledge Gold, Silver and Bronze suppliers. Also, consider launching a “Top Ten Suppliers” program where your company can list its best suppliers on a regular basis on your blog, website and internal and client newsletters. 
  • Rewards: Provide a plaque or statue top suppliers can display in their reception area. It is a simple token, but reminds suppliers on a regular basis that they are appreciated and also helps them attract additional business.

Suppliers want prospective clients to know they consistently meet and exceed expectations and are appreciated by existing customers. If you help their business by communicating their strengths to others, your suppliers will reward you with enhanced performance.

You may have a very long list of suppliers, so it is important to determine which of suppliers carry the highest impact for your organization. To help determine your high-impact suppliers, take a look at our Optimizing Supplier Performance White Paper for detailed guidance.

Supplier Management

Encore Presentation of Supplier Management Webinar

by Carmela Maia Friday, February 19, 2010

Intelex webinar "Tracking Your Way to Optimal Supplier Performance" sparked so much interest that we're going to offer it again on Wednesday, March 10th, 2010! Bevin Lyon, Intelex Executive Account Manager who has helped dozens of organizations implement supplier management software, will return as your host and subject matter expert to deliver valuable information and answer all of your questions related to supplier performance tracking.

A variety of supplier management concerns were discussed and Bevin also talked about what he believes a company's method of supplier performance evaluation should include: cost, delivery, service, quality, compliance, financial, safety, and information protection, all of which he addressed in further detail.

For instance, when evaluating a supplier's service performance, an organization should ask the following questions: has the supplier resolved discrepancies quickly? Has the supplier failed to respond to inquiries and requests? Does the supplier direct an appropriate level of technology towards customer service and process improvements? 

And in terms of quality performance, has the supplier provided products and services that consistently meet or exceed specifications, standards, and expectations? Does the supplier offer competitive warranties? Does the supplier comply with certification requirements?

To learn more and have your questions answered, register now for Intelex's encore presentation of "Tracking Your Way to Optimal Supplier Performance" on Wednesday, March 10th, 2010.

For more information on this Intelex webinar, or to ask questions about supplier management software, please contact Bevin Lyon at 416.599.6009 x244.

Supplier Management | Webinars

New Eco-Operation Study Sheds Light On Supply Chain Sustainability

by JP Nadeau Monday, August 10, 2009

Achieving verifiable sustainability throughout the supply and demand chain can be a daunting task for any company, especially for those who have a substantial amount of partners involved from top to bottom. As global product manufacturers are now placing more emphasis on being competitive and environmentally conscious as a result of social, economic and regulatory factors, pressure has mounted for companies to apply a “lean and green” makeover to their product sourcing, logistics, transportation, distribution and operational practices. In order to address the challenges, issues and opportunities associated with this trend, The Business Performance Management (BPM) Forum in partnership with Global Renewable Energy and Environmental Network (GREEN) have developed The Acceleration of Eco-Operation initiative. A rich repository of resources and information compiled from industry experts and associations as well as a comprehensive industry survey, The Acceleration of Eco-Operation initiative is aimed at helping improve bottom lines through enhanced trading partner visibility, flexibility and sustainability across the entire global supply and demand spectrum.

The BPM Forum, a comprehensive online survey of supply chain, operations, finance and executive professionals representing multiple industries was conducted in Q2 of 2009. It was designed to gauge how companies are presently dealing with the challenges associated with current supply chain demands, costs and environmental concerns. One hundred and twenty five professionals from around the globe participated in the survey resulting in insights as to what are the common priorities, pitfalls and progresses that supply chain professionals are facing today. The results of this survey were paired in a report with the detailed insights from 20 corporate and faculty leadership committee members outlining best practices and viable solutions aimed at helping companies begin to implement efficient and environmental practices within their supply chains.

The survey revealed that “nearly 90 percent of the respondents said their management subscribes to the principles of Eco-Operation, and nearly half said their executives believe in this mantra to a large extent.” This is a promising indication of the level of acceptance and understanding by the participants as to the fundamentals of the Eco-Operation initiative. The corporate leadership committee members were also in agreement as to the cost, compliance and carbon reduction advantages associated with Eco-Operation implementation. Although a good understanding and belief in the principles of Eco-Operations was noted, the report indicated that most companies are substantially lacking the means, metrics and visibility into their entire supply chain to successfully execute any of them. Almost two thirds reported inadequate visibility across all the tiers and levels of their supply chains. This lack of transparency can have a substantially negative impact on performance. As stated in the report, “The lack of transparency into the operations of dynamic, multi-tiered supply chains may be severely hampering business performance. Survey respondents identified the top business benefits of greater visibility as cost savings, better customer support, and environmental compliance – three key elements in today’s business landscape.” Also, better standards and key performance indicators (KPI’s) was identified as a nearly universal need among supply chain professionals as a means of measuring the sustainability levels of supply chain partners.

The report notes one of the driving forces behind Eco-Operational strategies and practices as the advent of web-based management platforms as a means of “increasing collaboration, real-time insight and rapid adaptability across today’s high performance, multi-enterprise value networks.” Such platforms, like Intelex’s web-based Environmental and Quality Management Systems work to foster a greater level of transparency and sustainability across the entire supply chain. Being web-based allows for a highly collaborative approach to monitoring your entire value chain as each supplier can easily access and use the system across multiple sites allowing for real-time reports and dashboards to be generated at anytime, ultimately giving you a 360 degree view of your entire operations.  With the BMP Forum survey indicating only 20 percent of participants as using a single hosted platform to improve such visibility; organizations who have implemented them have substantially realized measurable improvements in business and sustainability performance.  By investing in a web-based management system like those offered by Intelex, your organization is taking a step forward towards fulfilling corporate responsibility duties while at the same time streamlining operations, reducing costs, increasing sustainability and ultimately lowering your bottom line.

Read the full report here: Acceleration of ECO-Operation: Achieving Success & Sustainability in the Supply Chain

Business Performance | Environmental Management | ...

Organizations with Sound Quality Management Are Better Equipped To Weather the Current Economic Downturn

by Lori Dyne Wednesday, June 10, 2009

The purpose of a quality management system is to enable continual improvement regardless of market conditions; therefore, organizations that had the foresight and business smarts to have implemented effective quality management systems prior to the current recession have been proactively refining their business processes, minimizing the potential for nonconformance expenses, and enabling complete performance visibility as opposed to implementing last minute reactionary decisions intended to cut costs quickly. Invariably the "quick fix" approach to reducing the bottom line will directly impact product and service quality, which will ultimately have a negative impact on revenue generation.

The article "Prepared for Battle: Defend yourself in any economy with sound quality management" by Peter Grossi in this month's Quality Progress magazine delves much more deeply into the concept that businesses with existing quality management programs are better positioned to adapt during difficult economic conditions. "What organizations need to keep in mind, however, is that while the impact of a recession may be significant from a psychological perspective, in reality the application of sound quality management principles has a much more significant effect on an organizations success than the state of the economy."

So where does that leave businesses that don't have a quality management program in place? It leaves these organizations with a significant opportunity to improve their performance and strengthen their business operations so that they too can prosper regardless of the economic climate.

To read Peter Gross's complete article please visit the Quality Progress website. For information on the Intelex Quality Management System you can register for a live demonstration or free trial access online.

Business Performance | ISO 9001 | Operational Control | ...

The ASQ World Conference for Quality and Improvement: May 18-20, 2009

by Lori Dyne Wednesday, May 06, 2009
The ASQ World Conference for Quality and Improvement is being held at the Minneapolis Convention Center in Minneapolis, Minnesota from May 18-20, 2009. This year, Intelex will be sending three representatives; Bevin Lyon, Daniel Marcus, and Tomas Kuras. The guys will be available for live demonstrations of our:
  • Quality Management System
  • Nonconformance & Corrective Actions Module
  • Document Control System
  • Training Management System
  • Supplier Performance Tracking Module
  • Audits Management System, and more.
If you're already using Intelex's software please stop by for a visit! It’s always great to catch up with clients.

Audit Management | Corrective Actions | ...

Make Your Job Easier with the OpenPass API

by Lori Dyne Thursday, April 02, 2009

Intelex Technologies has released its latest software innovation, the Intelex OpenPass API, a revolutionary application programming interface that will enable its users to sync and report data between multiple business management systems.

The Intelex OpenPass API functions as a conduit for seamlessly feeding data between multiple software programs. This means that Intelex’s environment, quality, and health & safety, and business management Software can now share data with pre-existing business software applications; thereby, saving time and resources while maintaining a degree of accuracy that’s difficult to achieve when data is transmitted manually.

The City of Calgary and St. Gobain are the first Intelex clients to take advantage of the OpenPass API.  The City of Calgary used our OpenPass API to import employee and location data from their pre-existing HR system into their Intelex System. They also used the OpenPass API to export employee injury data (i.e., incident number with date and time stamp) from Intelex’s Master Incidents Module into their HR program.

St. Gobain used the OpenPass API to import training courses, employee lists, and employee workgroup data from Lotus Notes into the Intelex System and Training Management Module. By using the OpenPass API St. Gobain was able to quickly populate their new Intelex System with historical data that will be a key factor in reporting accuracy and trending.

If you think that your organization could use the Intelex OpenPass API to import, export, and sync data between a pre-existing management program and your Intelex System, send an email to client.relations@intelex.com or call 416.599.6009 for more details.

Audit Management | Business Performance | ...

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