Jackie Torfin, VP Global QA and Regulatory Compliance, Data Protection Officer,NAMSA
Throughout my career I have been tasked with building several “global quality systems.” It always starts in the interview process with the question, “Can you tell me about your experience building a global quality system?” Eventually, we get to the million dollar question, “How long will it take?” It’s always difficult for me to answer that question because there are so many factors that can influence the outcome.
The first thing people want to know is – what software will we use? How fast can we bring it on and roll it out? The truth is, there is so much work to do before you even begin to think about software. What kind of “global” system do you want? What processes do you want to globalize? There are generally three approaches: The Centralized Quality Management System (QMS), The Decentralized QMS, and the Hybrid QMS (LNS Research, 2013).
The Centralized QMS is generally led by a corporate team. Its purpose is to manage high-level goals and initiatives across the enterprise. The corporate team is responsible for standardizing procedures and processes, establishing training programs, publishing metrics and managing the overall role of quality within the company.Problems, from small to those that pose a high risk to the company, are immediately visible to the corporate quality team. Corporate structures that are particularly risk averse, or feel that they must maintain strict controls usually start with this model. In this model, the site level quality teams have very minimal influence in adjusting requirements that may be distinctive to their specific locations.
A Decentralized QMSis usually utilized by businesses that are comprised of a number of independent business units that are organized by region or product. These companies are also likely to have grown through multiple acquisitions. With the belief that each site or business should operate independently in order to allow acquired management the freedom to operate, they may not have taken the time to integrate new companies into their existing structure. In this model, the corporate office has little to no transparency when there are risk points or poorly performing systems.
Throughout my career I have been tasked with building several “global quality systems.” It always starts in the interview process with the question, “Can you tell me about your experience building a global quality system?” Eventually, we get to the million dollar question, “How long will it take?”
In addition, often customers may feel frustrated when they interface with the “global” company’s multiple processes, finding a confusing maze to walk through to get information.
The final approach is the Hybrid QMS. The corporate quality team manages only the global processes that can deliver the value of the centralized approach, while local quality management determines which processes deliver the benefits of the decentralized approach. Typically, centrally managed business processes include nonconformance, customer complaints and corrective and preventive actions, document control and document training management, and audit and compliance management. The management of quality issues that impact site specific operations like manufacturing, product release, even the design of new products, are done locally by site level quality teams. This approach is the best of both worlds, as it ensures transparency for risk mitigation of quality issues, but allows sites to be more agile in operational decision making. The end result is usually animproved customer experience.
Once the approach is determined, it’s time to build your business processes. You chose a Hybrid QMS that will give you local control over most operations, but will afford your executive corporate management risk transparency of quality events. Let’s build the process for customer complaint management first. A customer should be able to call any of your sites and give feedback about any poor service or product. No problem, each of your sites already has a quality process for complaint handling! They all follow the same regulation for complaints, therefore, this is a slam dunk. Excellent, lets buy the software and implement it next month.
Hold on…site one has a great process for valid and invalid complaints. In their experience, sometimes a complaint doesn’t violate a specification, it’s just something innocuous, like, “I don’t like this color green”, which isn’t really a complaint, it’s an opinion. In order to ensure their metrics are just measuring the true complaints, the site doesn’t count these opinions (or invalid complaints). Site two decided long ago that any slightly negative feedback from the customer IS a complaint, so this extra business process step won’t work for them. Site three could go either way, as long as the process includes the general manager’s approval on all complaints, which both site one and two think is ridiculously excessive.
Now the software vendor’s implementation expert is playing referee. And you are two months past your deadline. This situation can go a few ways. You could implement whatever process the software vendor suggests. You could choose one site’s process to automate. And in the worst case scenario, after everyone takes a step back and spends the time to design the best business process for your company, you could determine that the software solution you chose won’t work.
How long will it take you to build that global quality system? Once you have chosen your strategic QMS approach and designed the site harmonized processes, you can buy that software and it WILL be a slam dunk.