When to Globally Standardize a Quality Process

Standardizing a process across the enterprise carries with it both costs and benefits. Enterprise quality management software (EQMS) is making this transition simpler, much more appealing, and widespread.

Matthew Littlefield, LNS Research
Matthew Littlefield, LNS Research

Taking a process that has conventionally been carried out at the local level and migrating it to one that’s standardized across the enterprise carries with it both costs and benefits. While some could 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.

There are certainly some scenarios where it’s more appropriate to pursue such a strategy. And 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.

Deciding which processes to standardize
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 is 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 as a result 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 entering the supply chain?

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—in other words, processes that will deliver synergies when globally harmonized. Though 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
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 when different areas of business have different business drivers. For instance, a single organization may operate 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.

Closed-loop quality management
Though 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 could be a feedback loop between customer service and design, where customer complaint data would interconnect with the failure mode and effects analysis (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.

>> Matthew Littlefield is the President and Principal Analyst of LNS Research. To hear more thought leadership, follow him on Twitter @m_littlefield.

An unexpected error occurred: Timed out after 10000ms
An unexpected error occurred: Timed out after 10000ms
An unexpected error occurred: Timed out after 10000ms
More in Software