Compliance Posts

Key Reminders for Managing Suppliers

Mark Crawford

Supply chain management is harder than it used to be. Many OEMs are outsourcing more functions instead of keeping them in-house, adding geographical distance and cultural diversity to the supply chain. This, of course, adds complexity as well, which increases the chances of something going wrong and compromising quality. (more…)

SOPs: What You Need to Know

Mark Crawford

According to the FDA, the problem cited in 60 percent of all warning letters is SOP—standard operating procedures.

That’s actually a good thing because it is relatively straightforward (but not always easy) to fix SOPs. Identifying them is one thing—they also need to be concise, clearly written, well-communicated, monitored, and enforced. Taking the time to meet or exceed FDA SOP expectations will not only bring you into compliance but also improve operations and productivity in every department—leading to higher quality, improved profits, lower costs, faster delivery to market, and improved customer satisfaction. (more…)

Supply Chain Management Is a Big Target for the FDA

Mark Crawford

According to Alan Schwartz of mdi Consultants Inc., a former supervisor of field operations for the FDA, supply chain oversight is the FDA’s next big area of concern.

About a year ago the FDA indicated plans to expand its enforcement reach over foreign device suppliers through consent decrees. The FDA also asked manufacturers and importers to assume a bigger role in managing their supply chains. An FDA spokesperson, compliance officer Carmelo Rosa, further stated that “currently the agency only has authority to establish import alerts for foreign companies with good manufacturing practice violations, but is looking at other options.” (more…)

Take the Lead when It Comes to Compliance

Mark Crawford

Even though it’s easy to complain about regulatory agencies, without them things tend to get worse, not better (the financial industry, for example). There will always be companies that, when regulatory agencies aren’t looking over their shoulders, are tempted to slack off a bit, especially when the economy is tough, money is tight, and there are plenty of fires to put out.

So resist the temptation to slide (it’s always rough at the bottom). Be your own regulatory cop, whether you are being watched or not. Invest in whatever is necessary to fully understand compliance regulations, meet them, and even exceed them—for the simple reason that it is the best thing to do to protect yourself and your customers. (more…)

Managing Quality, Compliance and Risk in a Global Economy

Time to market is one of the major reasons we look to the global economy. Acquisitions and mergers can take us across international borders to quickly gain the intellectual property we need. International supplier sourcing can get products more quickly to our manufacturing sites and our customers, or broaden our foot print in a country quicker and faster. (more…)

Compliance is Nothing More than Risk in Sheep’s Clothing

Regulatory requirements around the world have grown, creating heavy workloads of documentation and the need for process transparency.  In addition to rising compliance concerns, Life Sciences organizations face increased security measures, including HIPAA, FDAA 2007 and more.

Regulatory risk is the possibility of being out of compliance. For many Life Sciences companies, regulations rule your compliance objectives. How you handle it is based on your product, production processes and your level of tolerance for risk. A high tolerance for risk might equate to lower compliance costs, but potentially higher non-compliance penalties.

The Three-Legged Stool: Governance, Risk and Compliance (GRC)

The Three-Legged Stool: Governance, Risk and Compliance (GRC)

Guidelines for governance, risk and compliance (GRC) affect nearly every company in every industry today, with different areas of scrutiny in varying areas of operations. Regardless of industry, however, successful companies reach corporate accountability by proving to stakeholders that their business is reliable, compliant, and sustainable.  To achieve this, a unified GRC strategy that guides people, standardizes processes, and integrates technology to embed governance, risk, and compliance must be established. (more…)

Taking Risks for Profitability – What Can We Learn from BP?

Taking Risks for Profitability – What Can We Learn from BP?

A series of internal BP memos were recently published by Congressional investigators which, they say, are proof that the British company systematically and negligently put safety at risk on the Deepwater Horizon oil rig in exchange for the prospect of increased profits.  Henry Waxman, chairman of the House Energy and Commerce Committee and head of its oil spill investigation, accused BP of making at least five questionable decisions prior to the disaster (see Times Online).  Every time BP had a decision to make, they  chose to cut corners; to do things more quickly than they should have; and, to take the less expensive route.  The consequence of these decisions is what has left us a blackened  Gulf of Mexico.  Time after time, it appeared that BP made selfish decisions that increased wide-scale risk for the sake of saving the company time or money. (more…)

The FDA Devotes Almost Half of its Staff to Product Regulation – Shouldn’t They Eat Their Own Dog Food?

Compliance and Quality management is crucial issue for almost any business, large or small. No matter what medical product your company manufactures or services, it’s a virtual certainty that you are beholden to an array of different regulations, both internal and from the FDA such as cGMP quality systems. Ensuring that your company remains in compliance with these regulations and proving the quality and safety of products and services at all times is something that can’t be left to chance. (more…)