Recently, ZenQMS VP of Customer Success, Emily Ruth connected with veteran Quality Management consultant (and ZenQMS implementation expert) Adaora Chukwu for a frank discussion about her role and what Quality teams in life sciences should expect from a partnership. The pair shed light on what to look for in a consultant, the services they provide, and how Quality teams can be set up for success once the engagement is over.
Here are 7 questions (and answers) to help Quality leaders understand how they can solve their quality management challenges by collaborating with a Quality Management consultant.
What is a Quality consultant?
Adaora: A quality consultant is a professional who has the required qualifications and experience to advise businesses on how to improve the quality of their products, services, and processes, hence assisting them in maintaining compliance and growth.
Why do companies hire a Quality consultant? What services do they provide?
Adaora: Quality consultants are engaged for a variety of reasons. Some of these reasons may include authoring SOPs, managing existing SOPs, document management, training, audit support, validation support, process development and improvement, maintaining an existing Quality Management System or implementing a new electronic quality management system (eQMS), among others.
(What is an eQMS? Get the 101 overview here.)
Some companies may have an eQMS in place, but an experienced quality member leaves, leaving an inexperienced staff or no one to manage the system. The organization experiences a major interruption in their Quality process flow, and the mitigation is to engage a good consultant until new employees can be onboarded and trained. This type of situation can be overwhelming, but with the right consultant, clients can set a course of action until they can have someone trained to assume responsibilities from the consultant or they can decide to keep the consultant onboard to oversee and maintain their QMS.
What’s the first step to finding a consultant?
Adaora: The first step to finding a consultant is for the client to narrow down their consulting needs to determine the type of consultant they need. Knowing this will help the client determine, during the vetting process, whether the consultant is a good fit. When interviewing candidates for a consulting role, clients should look for the following qualities:
- great communication skills
- interpersonal skills
- professionalism
- problem-solving skills
- analytical skills
- adaptability
- time management skills
- among others...
Referrals are good if the consultant has a proven track record of being knowledgeable and working well with clients. If the need for a consultant is related to an eQMS, and the vendor (like ZenQMS) offers referral services for consultants who have worked well with their system and their clients, that is a preferable option. However, the client must still determine whether the consultant is a good fit for their company and specific needs.
For eQMS consultant search, I would trust a referral more if it came from the eQMS vendor because they know exactly who’s proficient in their system.
Emily: Consultants should be self-aware and able to receive feedback. That’s critical. But remember, it’s a two-way street – the consultant will also be interviewing the client. They want to be sure it’s a good fit for them too.
What’s the next step?
Adaora: If the consultant is determined to be a good fit following the vetting process, both the client and the consultant must agree on a scope of work with clear expectations before signing a consulting agreement. A gap assessment aids in developing a proper scope of work by determining the current state of the quality system and what is required. This helps with prioritization of needs.
Emily: The consultant should perform a gap assessment before they get working on anything else. Doing this due diligence up front will help everyone understand exactly what’s there and what’s missing, and will save time and money in the long run. A lot of consultants skip this step and assume that they know the answers before doing the legwork. But that doesn’t build a strong relationship and could lead to aggravation if what was needed wasn't well-defined ahead of time. Remember, this is a collaboration. Everyone has to be on the same page.
Need help getting started with an eQMS? Check out these resources:
Do companies need to have an electronic quality management system (eQMS) in place before they hire a consultant?
Adaora: Companies don’t need to have an eQMS in place prior to hiring a consultant. A company might have a workable Quality Management System that is not electronic, but an eQMS is recommended because it saves time, making it more cost-effective. eQMS helps companies manage and streamline their processes. If a company wants to switch to an electronic QMS, they might work with a consultant to decide how the switch will benefit them.
→ Check out 5 signs it's time to invest in an eQMS
A qualified consultant can assess what the client has in place and determine what it will take to get to the desired state with an open conversation and guidance. Consultants may recommend which eQMS software to implement. (Need help getting leadership onboard with an eQMS? Check out our guide on how to create your case to leadership.)
What should you do if the client/consultant partnership isn’t going well?
Emily: Don’t prolong it. If deadlines aren’t being met, if there’s a lack of communication, and if the consultant doesn't relay the full capabilities of the eQMS in a way that’s helpful for the client, these are major red flags. They all point to the consultant doing the bare minimum and not working in the best interest of the client. End the relationship before it costs more money and frustration. That’s harsh, but that’s the answer.
Adaora: A client may believe that they have invested in a consultant and that ending the partnership with the consultant would be a loss, however, maintaining the consultant could be much more costly.
What should clients expect from the consultant before the engagement is over?
Adaora: Clients should expect transfer of information from the consultant to the team to ensure continuity. Ideally, you would have an in-house person(s) assume responsibilities from the consultant before the engagement is over. Discussions in preparation for the end of the consulting agreement should begin well in advance to allow for adequate planning.
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.