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Innovation is necessary for growth and often requires that risks are taken. However, a common sentiment is that compliance is getting in the way. Compliance is taking away our ability to innovate and to be profitable. This is not only heard for new business development but also when changes are made to existing operations. The pharmaceutical sector is one of the most regulated in industrialized countries. FDA has strict requirements for verification and validation of products and services. The risks to patients are many so it makes sense to scrutinize every aspect from design to delivery of new products. Changes made during the product life-cycle can lead to re-validation and conducting more clinical trials all of which introduce delays to the introduction of the new drug or medical device. In 2005, the Quality Risk Management program ICH-Q9 was introduced to bring a risk based approach to this industry. This was extended to the medical device sector through the ISO14971 Risk management standard. These were introduced partially to address the question of risk management and innovation and so were welcomed by the industry and FDA. This risk based approach leveraged the ICH-Q8 standard which introduced, among other things, the concept of design space. A design space establishes parameters that have been demonstrated to provide quality assurance. Once a design space is approved, movements within it are not considered a change from a regulatory point of view. This creates a space within the agreed boundaries for innovation to occur. Now, let's consider the process sector where we discover a similar notion referred to as, "Replacement in Kind" or RIK. Replacement in Kind uses the idea that when changes are made to the "design basis" a Management of Change (MOC) process must be followed to manage risk. Otherwise, the change is considered a "replacement" and not a change from a regulatory point of view. In many ways, RIK has the same effect that design space has in the Pharma/Med Device sectors. They both define boundaries that allow certain changes to occur that will produce the same design outcomes. Unfortunately, one notable difference between the two is how design basis is currently managed in the process sector. Design information tends not to be as controlled or managed as it in the Pharma/Med Device industry. In fact, it is common in older facilities to find that the design basis is no longer even known and engineers and maintenance crews default to the manufacturer's specifications for the equipment, parts, or material replacements. This has the effect of reducing the options and innovations that might otherwise be available. In a fashion, improving the management of design basis could allow for more innovation in the process sector. More changes could be considered as RIK without increasing risk. This would result in fewer MOCs and fewer resources being spent redoing hazard analysis, risk assessments and so on. Companies need to innovate and at the same time "play it safe" when it comes to workers, the people around them, and the environment. This is not easy but necessary. Re-imagining the design change process may be a good first step to support more innovation and staying compliant both at same time. Plan-Do-Check-Act Questions: How important is innovation to achieving the outcomes your business has targeted? What would it look like if more innovation could occur without increasing risk? In what ways has compliance hindered innovation in your organization? What steps could be taken to manage risk and increase innovation in operations and maintenance processes? #Compliance #Innovation #Design

In the early days of computing, companies would take "Commercial Off the Shelf (COTS)" products and create solutions to address specific problems found in operating their business. There was an important distinction made between products and solutions. Sometimes they were the same, although most often they were not. Products provided a set of core capabilities such as: a database, a document repository, or business logic often in the form of workflows. Solution providers would take these components and design applications to meet their customer's requirements. This approach was widely used for compliance processes for many years. Solutions required integration of data and capabilities that could address the entire scope of the problem. This often created the tension between choosing a "Best of Breed" and "Best Integrated" offering sometimes called product suites. "Best of Breed" products delivered best in class functionality at the expense of providing more comprehensive set of capabilities. "Best Integrated" products focused on delivering broader capabilities that where either well connected or could be connected together more easily. In today's world, the number of applications is numerous and the technologies mystifying. Deciding what apps to use or what services to subscribe to can be daunting. For those who use cloud services will know it is not ideal or even effective to have dozens of subscription services working in isolation and not working together. Choosing between products and solutions is still an important consideration today as it was in previous years. Instead, of choosing from among various COTS products, companies are choosing between "Killer Apps" and "Killer Platforms." In many ways, organizations are facing the same issues they did years ago although the vocabulary and technologies have changed. Plan-Do-Check-Act Questions: Does your company treat products and solutions as the same and what impact has this had on the effectiveness of the information technologies you use? In what ways has the implementation of partial solutions hindered your compliance processes? In what ways can the strategic use of "Killer Apps" help advance compliance? What opportunities do you see might improve the solutions you use each day? What is the next target condition for improving a solution you use most? #Solutions #ComplianceSolutions

Using up to date procedures and safe work practices is essential for maintaining safety of your workforce. Document management systems play an important role as part of a compliance platform to manage and deliver the correct documents so that appropriate procedures can be followed. It has been over 30 years since the introduction of digital document and record management technologies. So you might expect this to be a solved problem by now. In today's world of the internet no one should be spending time looking for or wondering if the procedure they have is the correct one or not. However, significant time is still spent searching for information that is needed to perform work. Source: Time Searching for Information. There are several factors that contribute to why this is the case that include using: system silos, out-of-date information, poorly executed or non existing management practices, and so on. I often find that companies may not even know what information needs to be managed. Identifying the documents, forms, and procedures needed by personnel in safety-critical roles is an important step towards improving timely access to procedures and safe-work practices. However, the most important factor may well be the mindset around document management. When you view something as a "solved problem" there tends to be no attention given to maintaining the process let alone improving it. Is it time for your company to take another look at document management and how documents can be maintained and delivered in a timely manner? Plan-Do-Check-Act Questions: What "solved problems" do you see in your workplace that need improvement? Which roles are most effected by information that is: incorrect, out-of-date, or not available? What do people do when they can't find the information they need and how does this impact safety risk? What is the next target condition to improve access to critical procedures and what is the first step towards that objective? #DocumentManagement #RecordKeeping #Procedures #SafetyCriticalRoles

Safety regulations and guidelines across North America call out for the need to manage risk due to organizational changes. Ensuring that safety critical roles are effectively maintained when changes are made to either personnel or positions is an essential requirement for every process or pipeline safety program. This is needed now more than ever as companies find themselves engaged in consolidation from mergers and acquisitions as well as adapting to changes in the market. Managing the following 5 (five) types of changes will help reduce risk during and after organizational changes have occurred: Personnel Changes refer to changes to safety critical roles, skills, and people Structural Changes are changes to safety critical positions, accountability, and critical management programs Temporary Conditions refer to transitional changes when people take on temporary assignments or as interim structural changes are being made. It is during these transitions that risk is at its highest and where maintaining safety is most critical. Policy and Procedure Changes can effect the ability to manage risk during the organizational change. For example, introducing travel bans may impact the ability to conduct field safety assessments. Risk Profile Changes during and after changes are implemented need to be assessed and managed appropriately. Managing these changes goes beyond on-boarding processes and involves process and pipeline safety expertise in addition to traditional human resource skills. A risk based approach is also beneficial so that the right level of rigor appropriate for the level of risk is applied. Plan-Do-Check-Act Questions: How well is your company managing risk during organizational changes? Is there a change process in place and how effective is it? Are safety critical positions identified and are roles effectively transitioned? Which ones need attention? What step can you take today to improve your organizational change process?

In recent years, standards and regulations have specified the need for companies to adopt improvement models or frameworks for their risk and compliance programs. The need for maturing systems is not new and there are many: methods, frameworks, and models that can be applied to improve business and compliance processes. Frequently, I come across those who promote approaches based on the CMMI framework along with those who suggest using the Plan Do Check Act (PDCA) cycle and everything in between. At a high level, CMMI takes a capabilities and systems perspective to improvement and has been used successfully for years. What makes the CMMI framework so compelling is that it provides a way to assess process maturity. You can identify where you are and what the next step should be. Likewise, the PDCA cycle has also garnered much attention due its success in improving quality. One of the ways that the PDCA cycle helps is when you know where you want to go but not sure exactly how to get there. It provides a way to take incremental steps, validate the results, and then advance further to the next objective. The LEAN Improvement Kata (IK) also referred to as "Toyota Kata" goes even further. This is a coaching approach where the best coaches help the learner to learn to improve. It is more of a meta approach and Toyota Kata is an excellent example of how this is done. The improvement Kata incorporates the scientific method to discover a path forward towards an overall direction instead of just a point improvement. In my experience, the CMMI approach is well suited to program level objectives and initiatives. Whereas, the PDCA cycle provides an accessible approach for front line workers to identify and implement incremental and equally valuable improvements to existing processes. The Improvement Kata (IK) with its focus on direction can help to align processes to overall system and sometimes even program objectives. Choosing a continuous improvement approach is important and you may need more than one. A common and unfortunate tendency is to use a "one size fits all" approach when making these kinds of decisions. Whatever approach you take, the important decision is to make continuous improvement part of your process at the onset. Don't wait until the last step in your implementation plan for this to happen. What is even better is when continuous improvement becomes part of your culture and practices at all levels of the organization.

If you are a Star Wars fan, you could call this "Creating balance in the 'work' force." Finding ways to accommodate new and changing regulatory demands is a challenge for most organizations. Very often I hear that operations is too busy to take on yet another process for their work force to follow. Even when the compliance process is as streamlined as it can be, front line workers may not have the capacity to properly execute and manage, let alone make continuous improvements to a new process. When compliance is layered on top of an already busy work force how could it be otherwise? One step that companies can take to create space is to simplify their existing processes before adding new ones. An effective way to do that is to remove sources of waste from existing processes by: eliminating unnecessary steps, reducing delays in acquiring resources, reducing unnecessary approvals, and no longer collecting information that is not needed By eliminating sources of waste you free up time for everyone to work on activities that are better aligned to the desired outcomes. Plan-Do-Check-Act Questions: What sources of waste do you see in the processes you use? What steps can you take to reduce or eliminate these sources of waste? What step can you take today to create space for compliance?

One of the first steps to improvement is creating the ability to "see" or "visualize" what it is you want to change. This is one of the key tenants of the LEAN mindset and it applies not only to the flow of work but also to the flow of data. In many organizations, data of all kinds remain largely hidden and not directly available to those that need it. Critical data is often buried in documents, reports, excel spreadsheets, numerous databases, and also now in the "Cloud". Many hours are wasted as people search for information they need to perform their jobs. This situation is expected to worsen as the demand for data continues to increase. Unfortunately, making data visible and readily available has not advanced as far as many had hoped. Even with the availability of numerous information technologies and now AI, information remains mediated behind administration staff, power users, and those that can remember were the report you want is located. The choice of technologies is an important factor to address hidden data. However, there are other significant factors that contribute to why data remains hidden. These factors have more to do with how data is governed rather than what technology is used. Examples include: Managing data in silos making data more difficult to find Not utilizing existing technologies that could help to make information more visible Continuing to support legacy systems that should otherwise be retired Recreating data whenever information cannot be found rather than identifying the root cause and fixing the process Not knowing what data is critical and what data can and should no longer be stored The management and availability of data is essential to supporting compliance processes. Without improvement in data visibility companies will continue to waste valuable resources recreating data, storing unnecessary data, and searching for information needed to perform roles. Question to Answer: What benefits would you see if data was more visible and easier to access? What would need to change to see improvements in how data is managed and made available? What steps can you take towards those changes?

The adoption of ANSI / API Recommended Practice 1173 - Pipeline Safety Management Systems will help improve overall pipeline safety. However, adapting to these new practices can be challenging after years of using systems and procedures embedded across the organization. Applying LEAN principles can help to visualize the entire process through value stream mapping so that sources of process and information waste can be removed before addressing new compliance measures. Download our presentation that looks at how lean principles can be applied to managing change within the RP1173 framework. #leanmanagement