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Jonah Krakow09/05/245 min read

Quality Q&A: Getting the most from your Quality Management consultant

This is Part 2 of our conversation with Quality Management Consultant Adaora Chukwu. If you missed Part 1, where we cover the basics, you can read it here.

In this article, we dive a bit deeper into Adaora’s experience as a Quality Management Consultant and discuss her recommendations for how clients can make the relationship with their consultant as productive as possible.

Q: After the vetting process, how can clients and consultants get started on the right foot?

Adaora: Both clients and consultants require clearly stated needs and expectations, beginning with the client/consultant agreement, which must be signed before any work is started. This is where you would outline the scope of work and set deadlines. To provide the best possible work for my clients, I must first understand their needs. For instance, do they want help implementing their electronic quality management system (eQMS)? Are they preparing for an upcoming audit? Are they looking to achieve a specific certification? etc.

Want more audit preparation tips? Check out these best practices for simpler audits.

If the needs are not well defined, the client may expect the consultant to perform additional tasks that haven’t been previously agreed upon. The consultant may be okay with the changes but it should not be an expectation. The new changes may not be in line with the consultant’s expertise or preferred area of work. A new or modified consulting agreement may be required. 

Q: What can the client provide right away to help you do the best job for them?

Adaora: The client and I start off with an initial meeting to discuss their priority list and items. Based on the scope of the project, I might need to be set up within the client’s system to ensure that the consulting engagement goes smoothly. This may include (if necessary) but is not limited to the following: getting set-up in the system, receiving access to onboarding information if I’m assisting with setting up new user accounts in their eQMS, insight into existing processes and SOPs, and introductions with stakeholders and other staff with whom I will be working. 

Depending on the nature of the consulting assignment, a consultant might be expected to use their own resources and deliver the final result to the client.

Q: Is there a “right time” to bring in a Quality Management Consultant?

Adaora: The earlier the better, but quality teams must have a budget to support it; otherwise, goals may not be accomplished. I empathize with Quality professionals since it appears that they are not part of the initial budgeting process. Even if they identified the need for a consultant early on, there’s usually not a lot of financial support unless there is an urgent requirement to be met. This puts the Quality team under a lot of pressure to accomplish a lot in a short period of time, which could lead to compliance issues.

Companies shouldn’t bring in a consultant before understanding what they are trying to achieve. It’s okay if they don’t have a lot of information and are still developing their processes, but providing something simple like a form, a flow that’s been mapped out, or an overview of what they’re trying to accomplish with their quality processes will help them get the most from a consultant. It doesn’t have to be detailed, because it’s my job to help them fine-tune it, but they should have an idea of what they are hoping to achieve.

The client’s goal is to achieve compliance, so the sooner the client recognizes the need for a qualified consultant and hires one, the better.

 

Q: What makes someone a good  Quality Management Consultant?

Adaora: A good Quality Management Consultant would possess a combination of technical skills and soft skills. Some of these skills include but are not limited to: demonstrated expertise, communication, collaboration, problem solving skills, professionalism, etc.

Q: What happens if the scope of the engagement changes?

Adaora: This happens from time to time, and it's fine. The changes have to be communicated as soon as possible. It may necessitate modifying the existing consulting agreement or establishing a new agreement with the same or a different consultant for that specific need.

It is up to the client whether or not to shift focus. I'm there to help and guide them through these changes. The client may be unaware of the implications so I assist them in understanding what the change entails and how it affects their current goals. The adjustments may affect the timeline. Clients can make better decisions about how to continue if they understand what the modification entails and how it affects the original timeline.

Q: How do you set up your clients for success before you leave?

Adaora: I prepare for the end of my consulting agreement in advance. I update the team on project status and any remaining tasks. I want my clients to be well-positioned for success after the consulting engagement ends.

In terms of eQMS, I assist clients in training the employee(s) who can manage the quality system after the contract ends, if needed. I make myself available to employees that want to learn about the system or need further assistance. If necessary, I provide the clients with a brief training guide that covers important elements on how to utilize the system.

Additionally, clients can choose to train one or two employees as super users, or they can hire a consulting company like Ground Up Consulting to serve as their eQMS Administrator to maintain their eQMS.


Adaora Chukwu (adaora@groundupconsult.com) has a successful career in Quality spanning over 20 years. She has held significant positions as Sr, Director of Quality, Head of Quality, and Director of Quality in an FDA-regulated company. In recent years, Adaora has transitioned her vast knowledge and experience into the realm of consultancy as the owner of Ground Up Consulting company. As a trusted Quality Assurance and Quality Management System consultant, she now empowers organizations across various industries to elevate their quality standards, streamline operations, and achieve sustainable growth. Emily Ruth has served as the VP of Customer Success at ZenQMS for 7 years, effectively guiding clients through product implementation and technical & account support, as well as liaising with dozens of consultants in support of their clients.