1
Sep

Managing Compliance Risk in Medical Device Manufacturing

The medical device manufacturer that had a spectacular compliance failure probably made the headlines. Their story will be noted in university classes around the world for years to come. Let’s look at another outcome.

Read more

8
Jun

Mitigating the Risk of Mobile Device Usage in Clinical Trials

Clinical trials are long, costly, and generally a huge undertaking for companies. Mobile devices can change that – they enable patients to participate remotely, saving money and time. That being said, mobile devices present some risks. Those risks can be mitigated, though. Read on to learn the risks of using mobile devices during clinical trials and how to mitigate them.

Read more

21
Mar

Risk Management: A Three-Step Process

Companies without a risk management strategy are vulnerable to disaster, where problems that were foreseeable deal a blow to profitability and even the organization’s existence. Proper risk management programs can help a company save time and money during internal and external audits. For companies regulated by governing bodies, risk management might be a required component of doing business by protecting things like public health records, financial statements, and consumer data.

In developing a risk management strategy, a company should follow a three-step process. The process kickoffs with working meetings that analyze business risks to discover the ones that pertain to the way the company does business. Once these risks have been identified, the company must try to quantify them by probability and extent of damage. Lastly, the company must develop a plan to manage and protect against each viable risk as well as developing a plan to mitigate consequences if the potential harm occurs.

A risk management initiative begins with an intensive look at a company because each organization is different. As important as risk management is to the success of the company, a program that is overly burdensome can negatively and needlessly hurt the bottom line. If a company is having trouble knowing what risks to focus on, they can reach out to professional consultants to guide them in the process. These consultants can help an organization create risk assessment groups of key stakeholders and business process owners.

Once these risk assessment groups have identified the specific risks to a company, they create a matrix of the probability of each risk combined with the impact on the business if the risk occurs. The higher the score, the more resources must be allocated to avoid and mitigate the risk. For example, risks that are likely to occur and would have extreme consequences if they did get the most attention. Conversely, low level risks that would inflict very little harm can be put on the back burner.

By assigning each risk to a business process owner, a company can assign responsibility to individuals, ensuring they get the attention they need. Without personal ownership, the risk can be forgotten and sneak up on a business. It is these business process owners who have the expertise needed to define an effective risk management strategy, ensuring that a mitigation plan remains relevant.

16
Aug

Mobile ERP Risks

With the rise of mobile devices in the workplace, the use of mobile ERP solutions has risen proportionately. After all, having access to your ERP solution at your fingertips gives you a number of benefits:

  • Real time access to important data for better and faster decision making
  • Quicker customer response time
  • More efficient data entry from the field
  • The ability to do more work remotely

But as with all technologies, there are some security risks that you need to be aware of should you decide to implement mobile ERP into your business.

Read more

14
Apr

6 Risks of ERP Implementations

Modern day ERP solutions merge data, technology and business processes.

Implementing these systems is a huge undertaking. Because of all the moving parts, there are risks associated with this type of project and if they are ignored – there is a good chance that the implementation will fail. For most, these risks are manageable if they are known ahead of time. Identifying what problems may arise and addressing them early will certainly help mitigate them before they become a point of failure for your project.

But just what are some of the common risks you may encounter:

  • No clear vision
  • Lack of user buy-in
  • Selecting the wrong software
  • Customization
  • Exposing sensitive data
  • Poor project planning

This white paper outlines these 6 common risks of ERP implementations – and how you can avoid being in the 55% – 75% of ERP projects that are considered “failures”.

24
Aug

Risks Associated with ERP Implementations

Modern day ERP solutions merge data, technology and business operations.

Implementing these systems are a huge undertaking and because of all the moving parts, there are risks associated with this type of project and if they are ignored – there is a good chance that the implementation will fail. For most, these risks are manageable if they are known ahead of time. Identifying what problems may arise and addressing them early will certainly help mitigate them before they become a point of failure for your project.

But just what are some of the common risks you may encounter?

Read more

27
Jan

Millennials and Mobility: Adapting to the Changing Face of the Workforce

The term Millennials has become popular to describe people born between the years of 1976 and 2001. Millennials are characterized by their aptitude with all things digital, their constant connection to social media and deep concern about their work/life balance. According to the US Bureau of Labor Statistics, this group will make up almost 50% of the workforce by 2020. Why do they matter to businesses? The way Millennials work has begun to indelibly and irreversibly shape the way companies operate, especially in the realm of mobility.

Read more

8
Oct

Risk Management for Life

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 

Risk can take many forms. Certainly, the most concerning is the risk to the patient but risk to an operator or employee must also be considered. There are regulatory and legal considerations and finally, there are issues that propose a business risk. Read more

31
Oct

Don’t Put Off an ERP Upgrade

ERP systems extend into nearly every aspect of a business, and the risk of business disruption related to the ERP system is one that most companies will avoid as long as possible. As a result, many companies delay upgrading their ERP systems longer than they should.

But these companies are ignoring the many opportunities that are available while running on newer releases of an ERP system.

Read more

26
Mar

Agile ERP Project Management

Nenad Simeunovic, Vice President of Services for Merit Solutions, was recently featured in the PM Network’s March 2013 issue discussing using Agile Project Management techniques for ERP implementations.

Here a short excerpt from the article, titled Big Delivery in Small Packages:

Eliminating Waste: Agile is based on lean processes that remove non-value-added activities such as downtime. As a result, agile components such as daily stand-up meetings can help project teams deliver ERP-related functionalities faster. "During the 15-minute meeting, each team member says, ‘This is what I did yesterday, this is what I’m going to do today and these are the obstacles I need help with,’" says Nenad Simeunovic, vice president of services at global IT services company Merit Solutions, Wheaton, Illinois, USA. "If there’s a challenge, we can address it on the spot and move on. As a result, there are fewer distractions, and progress is being made on a more consistent basis."

Agile’s benefits are especially appealing in the current volatile economy. "The departments are reluctant to tackle large-scale projects as one big initiative with scope, time and resources locked. Instead, they are looking more to deliver functionalities in iterations, where flexibility is allowed – even expected – due to rapid changes happening in the marketplace and in the organization. We can longer guarantee that our planning for today will be applicable in nine months," says Mr. Simeunovic.

View the digital release of the magazine, PM Network - Governing Creativity: Marrying Project Management with Innovation. The Agile ERP Project Management article starts on Page 60.