When You Should (and Shouldn't) Globally Standardize a Quality Process

There are a number of costs and benefits when it comes to migrating a process that’s conventionally been carried out at the local level to standardizing it across the enterprise. While some may argue that it takes away from the potential for site-level innovations and improvements, others praise global process standardization for its positive impacts on visibility, communication, and collaboration.

Follow @m_littlefield

The fact of the matter is, there are some scenarios where it is more appropriate than others to pursue such a strategy. Today, though, enterprise quality management software (EQMS) is making this transition simpler, much more appealing, and widespread. Market leaders are leveraging EQMS’s preconfigured solutions to quickly and cost-effectively deploy standardized functionalities across the enterprise.

This post intends to discuss when it makes sense to globally standardize a quality process, as well as shed light on the compounded benefits to quality process data and content that standardizing with EQMS can deliver.

Determining Which Processes to Standardize Across the Enterprise

To put the concept of enterprise-wide quality process standardization into perspective, consider the corrective and preventive action (CAPA) processes for a globally distributed company with hundreds of manufacturing facilities. It’s not uncommon for there to be as many different methods for investigating, recording, escalating, approving, and communicating corrective action-related information as there are sites across the globe.  

This traditional, fractured approach really highlights the need for the simplification and consolidation of critical processes, which is where EQMS can deliver major benefits. EQMS facilitates cross-functional communication and collaboration on quality issues originating across the value chain. The most value can be derived from automating a quality process that would significantly benefit when standardized, streamlined, and managed on its centralized platform.

In determining the ideal processes to automate with EQMS, some questions you may ask yourself or your cross-functional quality team are listed below. If you answer yes, then you may have a candidate for global harmonization.

• How similar are existing processes today? For example: Does your company have many different CAPA processes that are all very similar in terms of the workflow architecture but only have slightly different paths or use slightly different underlying systems?
• Does your company have many different systems for managing similar processes that drive up cost and complexity? For example: Has your company grown through acquisition and now has multiple EQMS functionalities for different divisions or sites? Does having these disparate systems add complexity for licensing and users? Does it increase IT and support costs?
• Has your company had compliance issues that can be attributed to non-standardized processes? For example: Have multiple audit processes increased the likelihood that your sites fail?
• Has your risk team identified multiple and overlapping processes as a source of increased enterprise risk? For example: do you have different ways of evaluating supplier quality for different sites that increases the likelihood of adulterated product from entering the supply chain?

Quality Processes that Deliver Global synergies  

Although there are many quality management functionalities and processes in addition to CAPA, companies tend to automate ones with EQMS that meet the criteria above; or, in other words, processes that will deliver synergies when globally harmonized. While this is not an exhaustive list of processes with these attributes, it shows several that have been widely automated with EQMS:

• Compliance/Audit Management: The regulatory environment is dynamic, making automation capabilities all the more important. Centralizing this information globally simplifies the audit management process, providing auditors access to on-demand and sharable reports.   
• Risk Management: Vital to compliance-burdened industries, managing risk with EQMS allows organizations to prioritize internal and external non-conformances based on the level of criticality. Having standardized risk factors provides a much deeper view of the enterprise risk portfolio.
• Document Control: Many companies have already taken steps to develop a platform for sharing SOPs, training documents, best practices, and so on. Document control capabilities found within EQMS can help to make sure these materials are in a centralized location and even get delivered to the appropriate parties across the enterprise.
• Others include customer complaint management, failure mode and effects analysis, supplier quality management, and more.

When it Doesn't Make Sense to Globally Standardize

It's important to understand that every organization has different needs and resources, and quality strategy should be developed accordingly. It's common for organizations across verticals to take unique approaches to quality. As a consequence, there are, of course, times where it doesn't make sense to globally standardize a quality process. Examples include:

• When organizations have limited IT resources: Companies with limited IT resources typically have to pick and choose which projects to undertake. If there isn't a good business case for global quality process standardization, then it's unlikely to get adopted.
• When there are different business drivers between divisions and business units: Especially with global and distributed conglomerates, there are times where different areas of business have different business drivers. For instance, a single organization may play in both the life sciences space and the F&B space, and as a result each industry has particular ways for managing FDA-related compliance issues.
• When the power structure doesn't support global quality: There are cases where plants have more control than corporate teams over quality. When this happens, quality motivations and budgets may vary throughout the organization, making it difficult to get global support as well as the executive backing needed for such a quality initiative.

The Enablement of Closed-Loop Quality Management

While the quality processes listed above deliver benefits when automated with EQMS, there are additional and arguably more important benefits that can be found by interconnecting complementary processes, which LNS Research refers to as closed-loop quality management. Closed-loop quality management is the concept of leveraging feedback loops that communicate quality processes and data back upstream to improve quality efforts earlier in the value chain.

An example of a closed-loop quality process may be a feedback loop between customer service and design, where customer complaint data would interconnect with the FMEA process. This can benefit numerous areas, from future product designs all the way downstream through the manufacturing process and even warranty reserve rates. Of course, the standardization of each of these processes with EQMS across the enterprise is what makes this a reality.

The Global State of EQMS

For a more comprehensive look into EQMS, join me and Quality Digest’s Dirk Dusharme for a webcast on the Global State of EQMS on June 25. With the use of benchmark data from LNS Research's 2012-2013 Quality Management Survey, taken by over 500 executives, the webcast will highlight best practices and strategies for implementing and getting the most out of EQMS. Sign up today!

You might also be interested in:

Top Integration Points for Enterprise Quality Management Software

Realizing Operational Excellence through EQMS

Microsoft SharePoint as a Platform for EQMS and Collaboration