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Timothy Lozier
Published: Tuesday, March 21, 2017 - 12:01 Compliance is a common term that is very broad, and many companies interpret compliance as a host of different items. It can be related to quality, safety, or operations, but it encompasses a long list of areas within the organization, including financial, risk, governance, sustainability, and more. Companies try to fit this broad category of compliance into a single term, which can be a daunting feat. However, compliance is not the only component on which companies should be focusing As a definition, compliance is the adherence to a set of guidelines, usually ones that organizations are not necessarily in control of. It’s created by a standards body, a regulatory agency, government regulations, or a requirement to do business in certain industries. Compliance, in a sense, is doing “what’s required.” But what’s required isn’t always the sole goal, and it shouldn’t be. In many industries, the term “operational excellence” is thrown out there, and it’s something that companies strive for but don’t always know how to achieve. Operational excellence is the process you put in place to adhere to the company strategy, toward the overall improvement of the bottom line. It’s how you leverage your performance metrics to really effect change, shift your organizational and operational culture, and go beyond meeting what’s required, to doing “what’s desired.” Operational excellence starts with people. You want to have a clear and concise conversation around quality. Often, getting from point A to point B can involve multiple methods, emails, files, spreadsheets, and comments. The challenge becomes one of keeping track—what are you tracking, and how are you tracking it? Are all the right people involved, and are you tapping into key knowledge from everyone in the business? The communications and actions taken in your process need to be tracked, accessible, and easy for people to leverage. But it’s more than just tracking—you need to make sure that all stakeholders are enrolled, that they want to participate so you can get the entire group of stakeholders contributing. Simply put, you need a single, central place where all your conversations happen. By tracking in one place and communicating more effectively, you know exactly how you arrived at a final outcome of the issue, and you can collaborate more effectively as a team. But this place must make it easy for people to want to communicate and collaborate. That’s why it has to be easy, simple, and effective. This is about making sure nothing is lost, and everyone is enrolled. Part of the new ways of looking at quality and compliance, such as in the ISO 9001:2015 standard, is about enrolling more people in the quality conversation. If you can make the conversation centralized, make it easy to go in and contribute, you can have more participation and more response. You will have better ways to filter out the clutter and track the processes related to solving compliance challenges in a more meaningful way. This removes the barriers to adoption, saves time, and reduces cost. Although enrolling people in the quality process is important, the process itself also needs to be connected. Your processes should relay information from one place to the next; if the information is related, it needs to feed into the next process so that no information is lost. For example, there is post-market feedback that comes into your organization (usually complaints) that you need to address. Typically, a complaint is assessed and then handed over for investigation. In a connected process, the information flows from the complaint to the investigation, with no manual reentering of information—it’s automatically there. If you deem the problem to be a systemic issue, does that information automatically move into the corrective action process? Is the information inherited? Once you’ve made the corrective action, how do you take that information, report on it, and effect change in the organization? These processes touch different parts of the business, but in an operationally efficient organization, it’s all connected in one “story of quality.” In a desired state, you want the process aligned, harmonized, and standardized so that everything is connected from start to finish. No data or information is lost, and the full story is there. But what about the critical component of demonstrating this story to someone who’s looking at it, like an auditor or inspector? In a desired state, you want an inspection-ready method so that when an auditor asks, you need only pull up a report that shows the entire story—how the complaint came in, what you did to investigate it, how you took corrective action, and what resulting actions or changes came out of it. This is what operationally excellent organizations do, and this is what’s desired. The concept of risk-based thinking is starting to enter the fray around quality management. Using the ISO 9001:2015 standard as an example, there are two areas where you are going to see risk. The first is on the leadership directives. ISO 9000:2015 is a companywide approach, and the leadership needs to be enrolled in the concept of quality. However, not all leadership are thinking in terms of quality. They don’t always “speak the language” of quality, and that can be a disconnect when you are trying to promote a culture of quality. Risk management acts as a “universal translator” of sorts to quality events. While leaders may not speak quality, they will be able to speak risk. That is why the standard encourages the concept of “risk-based thinking.” Risk-based thinking refers to a coordinated set of activities and methods that organizations use to manage and control the many risks that affect their ability to achieve objectives. Risk-based thinking replaces what the old standard used to call preventive action. The other area is the planning section of the standard. This is where preventive action used to be, and is now replaced with managing risks and opportunities. It is similar to the standard risk management process. Now, it’s worth mentioning that the risk view on ISO 9001:2015 is simply stated. This is not a directive to build an enterprise risk management program and change your entire processes to accommodate a governance, risk, or compliance initiative. It’s really part of the whole “broadening” of the standard, one that puts you in a mindset of risk rather than traditional quality terminology. Reporting is another key area where there is a disconnect between generally complying, vs. going above and beyond. Think about the amount of data that go into operations on a daily basis. There are many different ways you can collect information, whether it’s in the board room or the lunch room. Without a meaningful way to organize this information, centralize it, and filter it, you run the risk of missing critical pieces of improvement. Culture is about a shared, common set of values. In business, it’s about a shared goal, in this case, quality improvement for the customer. How can you eliminate the chaos and organize the information to come to a meaningful decision? How do you manage all the different tools and means so that you can use one place to make meaningful decisions? By centralizing your quality system, tracking in one place and communicating more effectively, you can have a single logical place where all the data related to quality resides—a single source of the truth. Then, you can take this information and report on it, export it, filter it, slice-and-dice it, and provide meaningful information to share with the company. Now you have a clear, common path to continuous improvement. Now—what about the change itself? From a culture perspective, you need to align on the need and the people involved in the change, but from a process standpoint, change needs its own process with its own workflow and milestones to be operationally efficient. If you think about what’s involved in the change management process, it can potentially touch a multitude of people and operational areas. From the point at which you decide a change is needed, you need to review the market impact, the design, engineering, manufacturing, supply chain, production process, and then market testing and launch. You also need to ensure that you are collecting the post-market feedback for future changes. Whether this is a product change or a process change, you will find that this may happen more than once; you could have change management happening multiple times, and sometimes it will come fast. Technology is a perfect example: By the time a new smartphone is released, the actual technology is already obsolete. So the process needs to be efficient and work in such a way that you can manage change quickly. Going back to the concept of a connected process, you need to make sure that your process for change moves the information seamlessly from one phase to the next. From the action plans, to any contingencies and deviations, to any sourcing of suppliers and beyond—you need to make sure that the process follows the correct method of hitting all the operational areas, the right stakeholders, and doesn’t lose data from one person to the next. People, processes, and technology bring you change. Closing thoughts These are key areas toward operational excellence. From a required state to a desired state, you can impact the business not just on a compliance level, but a strategic level. For more on this topic, join Timothy Lozier, director of product strategy for Verse Solutions, and Mike Richman, publisher of Quality Digest, on Tues., March 28, 2017, at 11 a.m. Pacific, 2 p.m. Eastern, for the webinar, “Achieving Operational Excellence: How to Create a Culture of Quality for Desired Outcomes.” Register here. Quality Digest does not charge readers for its content. We believe that industry news is important for you to do your job, and Quality Digest supports businesses of all types. However, someone has to pay for this content. And that’s where advertising comes in. Most people consider ads a nuisance, but they do serve a useful function besides allowing media companies to stay afloat. They keep you aware of new products and services relevant to your industry. All ads in Quality Digest apply directly to products and services that most of our readers need. You won’t see automobile or health supplement ads. So please consider turning off your ad blocker for our site. Thanks, Timothy Lozier is the director of product strategy for Verse Solutions, a quality and compliance management software provider that incorporates key quality processes, such as document control, corrective action, audits, and training in a dedicated cloud environment. Lozier has been involved in the quality and compliance industry for more than a decade and has an extensive background in quality and compliance management systems. At Verse Solutions he is responsible for driving the innovation and strategy of leading cloud-based compliance and quality management software solutions.How to Create a Culture of Quality for Desired Outcomes
Go beyond meeting what’s required, to doing what’s desired
People and the enrollment into quality
Process efficiency through technology enablement
Risk-based thinking
Reporting, metrics, and a ‘single source of the truth’
Culture of improvement and managing change
Achieving operational excellence is about going beyond doing what’s required. This means that you must take what you’ve already done for compliance and connect people, processes, and technology in an enhanced way. It revolves around having:
• A centralized way to communicate and collaborate across all stakeholders
• A process that is connected from one stage to the next
• A single method to compile and tell this story to those who need to hear it
• Risk-based thinking, so you can expand the scope, filter and make more objective decisions, and provide a means for everyone to understand quality
• Meaningful reports that provide that single source of the truth and let you create change
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Timothy Lozier
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Comments
Quality & Compliance
Quite a useful read.. throws light on why both quality and compliance are impoirtant...