A little over a year ago, the FDA issued a draft guidance document (Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection) regarding the types of actions that would be considered to obstruct an FDA inspection and potentially lead to a supposition of adulteration. Last month, the final guidance was issued. The document attempts to define what behaviors are considered to mean an intentional delay or refusal. The FDA has the authority to enter any facility under the jurisdiction of the FD&C Act at reasonable times and conduct inspections.Continue reading "Not Obstructing the FDA - Be Reasonable"
When the demands to a supply chain are smooth and predictable and the supply always matches the demand perfectly we can all live the life of Riley. Who is ready to take off work early this afternoon?Continue reading "Use Your ERP to Achieve Supply Chain Resilience"
The purpose of MDR reporting is to provide a means to collect data that may indicate the presence of a safety problem. MDR reporting can be confusing and it is certainly an area where mistakes are abundant. Some mistakes however will garner more scrutiny from the FDA. In extreme instances incorrect reporting or lack of appropriate reporting can lead to criminal charges.Continue reading "MDR Perils –Avoiding Entanglement"
Inventory management is central to getting the results you need from your ERP. At the same time, your ERP helps provide the good inventory management you need.
Inventory management allows you to properly plan your replenishment orders. Your inventory quantity is accurate so when the signal to buy or make more is received, you have confidence that you need to take action. Your ERP allows you to categorize parts which will help easily order the right quantity. One item is ordered only when there is a specific demand in exactly the quantity to meet the demand. Another item is lower cost and easily procured. Your goal here is fewer transactions so you order enough to satisfy all the demands seen in the next three months. Optimizing replenishments means fewer transactions and that leads to better inventory accuracy.Continue reading "Inventory Management and ERP Systems"
When questioned if their company has a focus on quality, most managers and employees will say yes. This might be because at a minimum, it is the right thing to say. They may also believe that since they have some procedures or a quality policy that this suffices and that quality practices will just fall in to line. Under further scrutiny, however the differences between perception and reality become apparent.
The view from higher levels in the company may be that it has a well disseminated quality culture. But as you travel down the organization chart, the response may not be so positive. A culture of quality is a full time commitment to quality. It is not just referencing standards in a few SOPs. Everyone should understand who the customer is and what they expect.Continue reading "Building a Culture of Quality- More Than Words Can Say"
What is workflow in the context of ERP systems? Simply put, it is the capability that many ERP systems have to link together several transactions or queries to guide a user through the steps necessary for a task.Continue reading "ERP Workflow will Improve the Quality of your Business Transactions"
Supply Chains have never been more dynamic than they are today. Their complexity has increased leading to risks associated with geography, compliance - even natural disasters. This occurs on the vendor and the customer side. It follows that as complexity increases, so do costs. When these risks are not appropriately managed companies can lose customers, profits and reputation.
Supply chains have gone global for a number of reasons. They may be seeking cost savings or they have capacity issues. Companies may outsource certain tasks seeking subject matter expertise or to allow themselves the ability to focus on core capabilities. Whatever the motivation there are times when it seems like the sky is falling but there are some best practices for supply chain risk management that can reduce the company’s vulnerability.Continue reading "Supply Chain Risk Management"
The goal of each medical device manufacturer is to produce safe and effective products. These manufacturers are responsible for carrying out postmarket surveillance activities to monitor and collect the performance of their products. In the current regulatory environment, companies are under scrutiny for their complaint procedures and their ability to react and respond.
The FDA annually receives hundreds of thousands of medical device reports of serious harm, deaths or malfunctions. These are not only from the manufacturers but also the end users. The regulation provides a means for the FDA to monitor significant issues regarding medical devices.Continue reading "Medical Device Reporting - Getting it Right"
The risk device companies assume is great. This requires a comprehensive planned approach. A policy on paper is not enough. It must be inherent in the day to day activities throughout the organization. Risk is constantly assessed and appropriate and timely decisions made. The goal is a reasonable assurance of safety and effectiveness of the product. In the simplest terms risk management results in the following:
- Identifies hazards
- Evaluates /estimates risk
- Determines risk acceptability
- Controls risks
Miriam and Gerry are receiving clerks. They are no different from millions of us who work hard and are underpaid. Their job only has visibility when something has gone wrong. Many days they will work hard all day and none of the higher-ups even know they were at work.Continue reading "Innovation is Everywhere and Anywhere"