David Thomas, Sr. Director of Global Services, Pilgrim Quality Solutions, an IQVIA company
Frequently, I’m on the road speaking with customers and addressing quality professionals, and frequently I’m asked, “If you had to give one piece of advice to someone looking to implement an Enterprise Quality Management System (QMS), what would it be? When implementing an Enterprise QMS, the best advice is inclusion.
It’s one simple word – inclusion – but one loaded with such wide-ranging positive impact.
Benefits of an Inclusive QMS
A global implementation team is imperative to successfully implementing a global Enterprise QMS.
- A designated team also builds global organizational buy-in and ownership to the process.
- It also ensures that everyone’s voice is heard and that regional or product-specific requirements are considered.
- Additionally, acceptance of the harmonized global process is more easily achieved because global communication and collaboration are demonstrated from the start.
Drawbacks of a Siloed QMS
Conversely, siloed approach will adversely result in one of two things. When implementing an Enterprise QMS, often organizations will use one site as the model for the rest of the organization. The result often is a lack of consideration for regional and product-specific requirements. This then typically results in multiple reconfigurations, or worse yet, modification of the solution in future phases. For Life Sciences organizations, this can mean additional policy, procedural, and work instructions updates. It will also require additional project overhead, re-validation of the solution, and re-training of personnel. Do this too often and project fatigue can set in, and time-to-value is significantly elongated.
Another adverse result of a siloed approach is the risk of the appearance of “acceptance.” This leads to multiple work-arounds, back-door processes, and spreadsheets and other documents to support how it “really” works. When this occurs, there is no longer a “Single Source of Quality Truth,” and the organizational synergies, efficiencies, and flexibility, as well as the global visibility and common language of the organization, are not achieved.
This doesn’t mean a complete big bang approach has to be taken during the implementation of a global Enterprise QMS. Many organizations cannot support that level of resourcing. So how does an organization reasonably make the transition from a siloed to an inclusive approach?
Best Practices for Conversion to Inclusion
An organization might start with one end-to-end process, maybe for a particular product family, with a global team leading the charge. Consider the end-to-end process for managing a nonconformance. This won’t be inclusive, just enough to depict the reason for implementing an end-to-end process rather than a siloed process.
First, take into account the sources of nonconformance; suppliers, product, processes, etc. The first consideration in an end-to-end nonconformance process is to ensure all types are identified.
To peel this back a bit more, look, for example, at a supplier nonconformance which will illustrate why an end-to-end process is key to avoiding missed integration points. At receiving inspection, a material nonconformance is created due to out-of-specification inspection results. The nonconformance investigation reveals that the material cannot be used or even re-worked for use. As a result, the material is dispositioned, an ERP inventory status update is submitted, and an ERP return material authorization is potentially triggered.
Additionally, the nonconformance investigation indicates that this is a trend for this supplier, and therefore a Corrective and Preventive Action (CAPA) is issued. The CAPA investigation uncovers the fact that a design change was not considered in the material the supplier shipped.
In turn, this triggers a supplier audit to determine why the supplier QMS processes missed the change notice, or if something changed in the suppliers’ process capabilities. Yet another possibility may be that the CAPA investigation reveals that change notices are not getting sent to this supplier because Engineering was using an outdated SOP.
This will initiate a change request to update the SOP, and additional training is triggered for the Engineering group.
This of course is a simplified example; the point for choosing an end-to-end process is this: there are both internal QMS integration points as well as external integration points that will be missed without a complete process view. Additionally, the global team needs to participate in this process to ensure regional reporting requirements are not overlooked, thereby creating the need for “rework” later.
Through the discussion above, the necessity of a global voice (inclusion) during implementation is clear if an organization is to achieve a successful implementation of an Enterprise QMS. That global voice not only ensures a harmonized process; it also drives organizational synergies, efficiency, and flexibility that work for all sites around the world. It will improve organizational acceptance and shorten global time-to-value.
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