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11.27.2018 Robert Fenton

Quality Management Consulting: How to Evaluate and Choose the Best Consultant

If you're trying to find a great quality management consultant, you understand that the right expert can bring a lot of value. Quality management consultants can help life science organizations achieve certification, implement new software, and improve overall quality. So, it's wise to expend some effort to find the right fit.

Business outcomes ultimately measure the difference between merely capable and high-value, exceptional consultants. A quality management expert can help you achieve compliance by a target date, and they can strengthen your processes and create lasting business value.

Evaluating potential partners requires understanding your company’s needs and goals, and matching that to a consultant’s qualifications. In this post, we'll reveal several factors that set the best consulting professionals apart and show you how to select the right partner.

How to Find a Great Quality Management Consultant

Regardless of whether your organization is looking for a consultant for the first time or you've worked with a consultant in the past, it's an important decision. The right quality consultant can play a critical role in the success of high-stakes, short-term initiatives. Depending on your goals, the consultant could also be a long-term resource for your brand.

Performing due diligence is an integral part of any prospective business partnership. Work to understand a consultant's unique approach and the methods and techniques they use. Evaluate cost, references, your organization's needs, and the consultant's experience from a holistic perspective.

Find Someone Who Fits Your Needs

For life science firms, quality management consultants can fill a wide range of roles which can vary depending on the goals of the partnership, the stage of the organization, and other variables. Sometimes, consultants help build quality controls and management systems from the ground up. At other times, a specific use case can spark the decision to hire a quality management consultant.

Understanding your needs is critical to finding the right type of support and expertise. Keep in mind that "great" is subjective. The best consultant for a new startup may not be one with experience only in well-established firms.

Start this process by envisioning the consultant’s ideal role, which may fit into the categories of advisement, project management, compliance expertise, or ongoing support.

  • Are they going to act as an expert advisor in translating complex standards into processes?
  • Will they be an on-the-ground technical expert, acting as a project manager during a system import?
  • Do they need to help with compliance requirements by a deadline?

Consider the size and stage of your firm and how this should shape the consultant’s experience and role.

  • Do you need full analysis and system design?
  • Are you hoping to implement or upgrade systems?
  • Do you need audits of existing, mature systems?

Needs should play a significant role in selecting a quality management consultant who can provide the most value during an engagement. How closely a consultant's experience matches up with your needs can shape whether their performance is excellent or simply adequate.

Before you launch an in-depth search for a quality management consultant, ensure you fully understand your own organization’s needs and goals. Understand where you are as a company. Use our simple tool to discover your quality score by taking a short, insightful quiz which reveals opportunities for improvement.

What to Look for in a Quality Management Consultant

Quality management consultants can come from varied backgrounds and professional experiences which provide expertise in a complex industry. While all consultants need general knowledge, focus on the areas of their experience which best align with your own needs to determine their ability to help you achieve certification or adopt a new Quality Management Systems (QMS). Life science quality management is a highly specialized field, so take that into account during your selection process.

1. Does the consultant have relevant industry experience?

Quality management in life sciences is a uniquely multi-disciplinary field. Consultants with industry experience are best prepared to help address regulatory standards, QMS implementation, and other quality initiatives. The consultant should have experience with successful client engagements or work history at life science companies that closely resemble your own.

Evaluate the prospective consultant's experience and how closely it aligns with your organization's goals. Consider whether the consultant has sufficient knowledge to address the unique challenges of your vertical or organization's growth stage.

2. Has the consultant successfully designed or improved management systems?

Does the consultant have a track record of successfully applying a QMS which delivered long-term business benefits? The consultant must be armed with relevant knowledge to address specific system challenges around quality, information systems, or other use cases.

Evaluate this experience by working to understand the consultant's success rate and system-specific knowledge. Ask for success stories which closely resemble your own need to determine how they have helped similar organizations design systems, set quality objectives, or measure customer satisfaction.

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3. What is their standards experience and the certification success rate of former clients?

All quality management consultants need experience and knowledge with interpreting FDA and ISO standards. If you're hiring a consultant to help guide your organization through certification, their standards experience is especially critical. Ask or evaluate the following:

  • How many clients have they helped achieve certification with applicable standards?
  • What is the success rate of clients who applied for certification?
  • Can they provide training to your staff on standards?

4. Does the consultant have relevant QMS software experience?

Quality management consultants may specialize in systems, strategy, processes, or people, but all consultants need familiarity with modern QMS software. Understand the types of systems and vendors your consultant has worked with before, and how they used technology to help drive success in use cases similar to your own.

If your goal is to implement or upgrade systems, you'll get more value from the partnership if the consultant has existing knowledge of that particular system. For highly technical consulting engagements, you may consider asking your QMS vendor to recommend effective consultants who are competent in their software.

A Great Consultant Candidate Should Inspire Confidence

A quality management consultant must have industry experience and knowledge of systems, standards, and management systems to bear close consideration. If they meet all of these requirements, they could be qualified to drive success.

What matters more than evaluating that a prospective partner has experience, however, is working to understand the quality and relevance of their expertise. Beyond just checking off qualification boxes, the right consultant should be able to instill confidence based on similar projects with satisfactory outcomes.

Where to Look for a Quality Management Consultant

Finding qualified consultants can be a challenge, especially in verticals where talent is in particularly high demand. Sourcing a strong talent pipeline is essential, and we recommend continually working to develop a list of potential candidates for future engagements. Peer recommendations, certifying bodies, and vendors can be surprisingly valuable sources for guidance:

  • Ask your network of peers and colleagues for consultant recommendations.
  • Attend industry events to expand your network and meet consultants and talent.
  • Source talent from certifying bodies, such as the NQA or the American Society of Quality.
  • Inquire if your QMS software vendor has recommendations on independent consultants.
  • Check with your QMS software vendor to see if they provide QA/RA consulting / strategy support through their platform. (We do.)

What to do Before Contacting a Quality Management Consultant

Approaching a consultant search with broad success measures can make it challenging to narrow candidates effectively. However, understanding what defines a great consulting engagement is a powerful tool for evaluating a prospect's relevant experience and knowledge of management systems, standards, and software.

It's best to go into a consultant engagement with some idea of what tasks will be prioritized. One way to understand which levers a great consultant will pull to implement a culture of quality is by downloading our free eBook: 7 Things You Can Do Now to Improve Quality in Medical Device Product Management.

 

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Published by Robert Fenton November 27, 2018
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