Risk

Risk Management greatly reduces inefficiencies resulting from unanticipated operational disruptions.

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Compliance

For regulated organizations, quality problems & non-compliance have serious consequences

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Quality

An integrated and effective quality system is key to improve efficiency & compliance in manufacturing operations.

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Posts Tagged ‘Supplier Quality Management’

Monitoring Supplier Performance throughout the Product Life Cycle

Monday, June 20th, 2011

Knowing your suppliers is as important as knowing the resources themselves. If you have a product defect, it doesn’t matter if it was a supplier’s fault or your own – the only thing the public will see and react to is your product and brand. Ouch. It pays to keep a tight control on supplier management.

The first step in understanding suppliers is through an evaluation and acceptance process. What are their business systems? Are they financially stable? What does Dunn & Bradstreet have to say about them? What percent of their sales is the product or resource you need? If it’s not substantial, will that affect the quality?

What is the capacity of the supplier’s operations? What technology do they use? Do they have a good reputation in the industry? Are their product costs and distribution costs in line with competition and your budget? Physically, where are they located, and who are your points of contact?

Suppliers come in many flavors, such as:
• OEM (original equipment manufacturer) –design control
• Contract manufacturer –process control
• Critical service provider –data control
• Critical material supplier –material control
• Catalog/off the shelf material supplier
• Routine or low-risk service provider
• Distributors
• Sister plant –depends on patient safety impact of service or material

You need to ask yourself a set of questions to determine your risk with this supplier, and assign a value to your response such as “adequate, deficient, unsatisfactory,” or a numerical value that can be calculated to equal a total score. Include questions about the market and classification of the device. Consider regulatory requirements and any past or risk of exposure due to product recalls. As far as the manufacturing capability and supply chain, consider how many suppliers, the number of sources, and supplier manufacturing location. What is their technical capability and how does that match with yours? Finally, for quality purposes, are they certified to ISO 19001, ISO13485, etc?

Assigning a risk criticality level to your suppliers will help determine how to control and monitor the supplier relationship: high risk or level 3, medium risk or level 2, or low risk, level 1. Based on this ranking, you can then determine the frequency and type of supplier audits commensurate with risk (bi-annual, annual, third party, etc.). You can determine the frequency and type of inspections, from dock to stock, sampling, first article to 100% inspection. You can determine the quality metrics (SCAR response time, thresholds, PPM’s, etc.).

As for performance monitoring, there are many factors you can look at, such as:
• Parts Per Million (PPM’s)
• Nonconformance’s (NC’s) – “trend”
• Supplier Corrective actions (SCAR’s)
• Key Performance Indicators (KPI’s):
• On-time, Inventory Turns, COPQ, Rejections, etc
• Scorecards: quality, cost, service, delivery, compliance
• Risk
• Technical data trends

Find the metrics that are right for your product or process and supplier relationship, from scorecards and global supplier ratings to approved supplier list (ASL) and SCARS-Feedback and more. Update your supplier risk profile and analyze it to monitor the “health” of the supplier in real time. Monitoring the performance of your suppliers throughout the product life cycle can help you identify problems and rectify them before they become a potential brand disaster.

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So now that the Food Safety bill has passed, what’s next?

Monday, January 24th, 2011

 On January 5, 2011, the Food Safety Modernization Act was passed into law by President Obama.  The new legislation gives the Food and Drug Administration the power to recall tainted food, quarantine geographical areas and access food producers’ records. According to the FDA, the burden of foodborne illness is considerable.  Every year, 1 out of 6 people in the United States — 48 million people — suffers from foodborne illness, more than a hundred thousand are hospitalized, and thousands die. So what does the new legislation mean to food processing companies and manufacturers now?

 It seems like we’ll have some time to figure it out as an estimated $1.4 billion dollars will be needed to implement the new processes, including hiring thousands of FDA inspectors.

Additionally, the FDA will be faced with writing regulations which with food processors will have to comply, and new produce safety standards and an inspection schedule will all come under intense scrutiny. You can be sure however, that the new law will involve preventive controls, records maintenance and access, and supply chain management; controls over imports, such as foreign supplier verification and third-party certification; enhanced FDA enforcement of mandatory recalls and more frequent inspections; and, new fees for food companies and importers. Sound familiar? Although change is upon us, many of these topics aren’t new. We’ve been working on them for years.

 Consumers are already voicing their thoughts. In one blog, a reader said that the “food industry will get the message” if surprise FDA inspections happen every week. Many others think it’s all a political game and really will do nothing to protect our food supply.

 For the industry, we should view the new bill as a building block to what we’ve been striving to perfect – best practices in quality management product and processes.

 Food suppliers, and quality management and safety professionals can sit back and play the waiting game along with the politicians, or we can stand up for our industry and give consumers what they want — confidence. How can this be accomplished?  A quality and safety management program needs to address the system as a whole – a global program, trained employees, well-documented SOPs and utilizing technology properly to put global practices and procedures in place. A well-designed and implemented safety and quality management system can reduce risk and improve performance and profitability.

 By having total automated quality and safety process control, food processing companies can look at achieving consistent yield and uniformity from product to product, and from batch to batch, with increased traceability and trust along your entire production process for complete sustainability.

 While the politicians duke it out, let’s assume accountability in our own backyards and invest in our quality and safety management systems now.

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Are They Just Pulling Our (Supply) Chain?

Thursday, July 15th, 2010

The FDA, Congress, the US Consumer Products Safety Commission, US Immigrations and Customs Enforcement, the Department of Justice. These and countless other regulatory bodies are more proactively evaluating the potential risk and liability to our country’s goods and products; and as we’ve seen, the sharing of information among these regulatory bodies is leading to more cohesive enforcement activities with the continuous goal of protecting the consumer.

For the consumer, this is great news: increased regulatory enforcement in the name of consumer protection. For the manufacturers, however, the perception has long been that facing broader, stronger enforcement represents increased operational costs, complicated administrative processes, and for many, a major headache.

On the flip side, sitting passively in hopes their number doesn’t come up (surprise inspections, bad press, recalls, even bankruptcy) is likely to induce more than a migraine, but full-scale disaster. More and more manufacturers are sensing that they’d better keep a close eye on their operational risk factors. And this includes not only in-house operations but their full-scale supply chain. To the consumer, the top of chain ultimately liable for what happens along the way up.

So are the regulatory agencies just pulling our chain in the name of consumer protection, or should we, as a nation of manufacturers, really be sharpening our focus on supply chain issues?

For those that choose to ignore the risks and maintain a myopic view of their operations, all they have to do is take even a blurred look at what’s been going on out there in just the past few months to know how critical it is to shore up their entire team:

  • Johnson & Johnson has been hit with five lawsuits seeking class-action designation in the wake of its recall of OTC children’s medications. The voluntary recall by J&J subsidiary McNeil Consumer Healthcare was the company’s third recall in an 8-month period due to quality problems, prompting the FDA to look into hundreds of adverse events, including 37 deaths linked to recalled products. One complaint stated: the company’s action clearly shows “an utter disregard for the safety and welfare of the children who use their products.”
  • Wegmans Food Markets replaced its supplier of store-brand dry pet foods because of “a disappointing relationship with the previous supplier, including recalled products due to a strain of salmonella found in (the supplier’s) facility.
  • A multitude of major product recalls by Toyota (and its luxury Lexus brand), in particular, the largest resulting from the stuck accelerator situation, have tarnished the company’s previous stellar reputation as a producer of reliable vehicles. CTS Corporation of Elkhart Indiana, the supplier that produces the accelerator assemblies for Toyota stated in a press release issued on its web site that an accelerator friction problem accounts for just a few cases of stuck accelerators. CTS noted that its products are not implicated by the November 2009 Toyota recall, but further states “that CTS has been actively working with Toyota for awhile to develop a new pedal to meet tougher specifications from Toyota.”

So who’s to blame in these and countless other reported scenarios of potential and realized consumer harm – spinach, peanut butter, ground beef, defibrillators, baby formula, Heparin? There are so many potential parties as fault, particularly among complex, multi-tiered, global supply chains. Yet, no matter how far down the chain, it’s the manufacturer whose name is on the label that takes the blame.

So, no, those regulators aren’t just pulling your chain. They mean business. And those manufacturers who don’t want to see their profits or their operations get washed down the drain, will have to respond to the growing pressures from these bodies to develop, implement, and maintain a supplier management program that integrates compliance, oversight, and strong supplier relationships into business practices and quality systems.

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