Do you how much your company spends on the cost of poor quality (CoPQ)?
The average highly regulated organization spends 5-30% of gross sales on CoPQ, according to research cited in Quality Digest. Most executives admit they don't know their company's avoidable quality costs, according to the same source, or underestimate CoPQ as less than 5% of revenue. You may have a business case to hire quality management consulting services if your organization is struggling to rein in expensive quality concerns like nonconformances or rework.
Excessive quality costs aren’t the only reason organizations in pharma, medical device fields, or life sciences should consider hiring specialized consultants. Perhaps you’re trying to implement enterprise quality management software (eQMS) for the first time or achieve certification with standards such as ISO 9001 or 13485. Quality management consultants can serve a variety of roles in organizations, and the best specialist for your needs is someone whose experience matches your goals.
Evaluate your needs carefully to understand whether you need a consultant. Quality management consulting services that are often hired to bring a well-established pharma company into compliance by a deadline may not be the right fit for a medical device startup which is trying to implement eQMS for the first time.
In this post, you'll learn how to evaluate quality management consulting services based on the quality of service offered, consultant experience, and the strength fit with your organization's needs. You'll also learn some common use cases for quality management consulting services, and some little-known resources for finding a highly qualified candidate.
What Quality Management Consulting Services Actually Do
Quality management consulting services provide a broad range of advisory services, support, or technical talent to help an organization achieve successful project outcomes in quality initiatives related to compliance, certification with quality standards, quality management systems software, training, and more.
Quality management consulting services can fulfill a variety of roles in an organization by providing expertise related to systems design, improvement, or effective quality practices during periods of organizational change which can impact quality systems. A highly regulated organization may choose to hire consulting services for a variety of either short-term or long-term engagements. The duration of a QMS consultant’s service may range from a period of several weeks to months, or even years.
Consultants at firms which provide QMS services should have experience and qualifications which are directly relevant to their work in highly regulated industries. This may include success with eQMS systems implementation, a background in executive leadership or quality control, or a proven track record of helping multiple organizations achieve QMS certification.
Quality management consultants can fulfill a variety of roles within an organization. Some of the most common use cases for hiring a consultant include compliance, technology, training, or establishing new capabilities. To help you evaluate your needs against this solution, we’ll define several common roles for a quality management consulting service.
1. Help You Achieve and Maintain Compliance
Quality management consultants can offer experience in achieving compliance with regulations such as FDA cGMP or EudraLex GMP. They can provide a comprehensive range of support to organizations, which can range from achieving initial compliance at a startup to fixing non-compliance issues at a more established organization. Quality management consultancies can also support the establishment of quality controls and processes to maintain continuous compliance.
Some of the specific reasons an organization may hire a quality management consultant for compliance support are:
- The implementation of a compliant eQMS
- Voluntary compliance audits
- Advisory support for the quality unit or leadership
- The creation of an internal compliance function
- Emergency response to compliance risks
- FDA warnings and interactions
At startups and scale-ups, a QMS consultant can guide the creation of compliant quality systems, including systems to support document management, training, and complaint tracking. They may also provide support for the establishment of consistent standard operating procedures (SOPs) for a growing organization, perform internal audits, or audit components of the supply chain. At more well-established organizations, a quality management consultant may provide emergency response to notifications of non-compliance such as FDA 483 observations.
2. Help You Implement a QMS
Effective quality management systems can boost revenue by offering a diverse series of benefits, which include consistent product quality, minimizing rework, improved collaboration, and a healthier culture. Quality management consultants can provide support for the adoption of frameworks such as ISO 9001 or implementing compliant QMS software.
A quality management consultant may provide support for the initial implementation of a QMS at a startup or small-to-mid-sized organization which is in the initial development phases or help a well-established organization transition between quality management software systems. A quality management consultant could also provide advisory and audit services to a highly regulated organization that is seeking to improve their quality systems to achieve product approval, reduce waste, or achieve cultural improvements.
A quality management consultant who is hired to help an organization integrate a QMS should have relevant experience in the design, implementation, and improvement of formal quality systems in pharma, life science, or medical device organizations. A candidate should also have expertise and direct experience with ISO standards and regulatory requirements in the U.S. and international markets. Depending on your organization’s needs, a quality management systems consultant could help you:
- Select and implement a new eQMS software
- Transition your organization between eQMS systems
- Provide system validation or revalidation support
- Perform a comprehensive quality systems audit
- Add new quality system capabilities, such as CAPA
- Guide certification efforts with ISO 9001 or 13485
3. Train Your Team
FDA warning letters frequently cite non-compliance with 21 CFR 820.25(b), which requires cGMP-compliant organizations to “establish adequate procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.” Quality management system consultants can provide critical support to organizations in training, which ranges from the establishment of training procedures at startups to the audit of training systems at SMB.
Quality management consultants may provide individualized or staff-wide training sessions based on an organization's needs. This may include training on ISO, internal auditor skills, management review processes and responsibilities, documentation, or other vital capabilities. Ideally, a quality management consultant who is hired to train staff members should verify that an organization has compliant systems for tracking training activities and provide individualized, hands-on learning experiences to staff members.
4. Help You Work Through CAPA
Quality management consulting services can support organizations in the development of a corrective and preventative action system (CAPA) as a scale-up approaches the market approval phase of the product lifecycle. At SMB or large organizations, a consultant may perform a comprehensive review of CAPA to discover opportunities for improvement.
Effective CAPA systems are integral to operational efficiency, quality products, and regulatory compliance. Depending on an organization's need or stage, CAPA consulting services may provide support to:
- Select and implement an eQMS system with CAPA capabilities
- Train the quality unit and staff on CAPA procedures
- Comply with regulatory requirements such as FDA 21 CFR Part 820.100
- Identify quality issues before they lead to an FDA notice or customer complaint
- Respond to FDA warnings about insufficient CAPA systems
- Provide “objective evidence” to regulatory agencies
Where to Find a Quality Management Consulting Service
If you think your organization could benefit from a quality management consulting service, the first step is to define your use case to the greatest extent possible. While a quality management consultant can provide broad support, it is helpful to envision a consultant’s ideal role:
- Do you need an advisor, compliance expert, technologist, or ongoing support?
- Is there a need for a process expert to create SOPs from cGMP?
- Are you looking for an eQMS expert for a software implementation or system import?
- Will your organization need to meet compliance requirements by a deadline?
Based on the answers to these questions, you can further refine your expectations and understand whether you're hiring a consultant for system design, upgrade, or to perform audits of existing quality systems.
A great candidate to provide quality management systems consulting to your company should inspire confidence that they can bring a project to success, based on:
- Relevant industry experience
- Knowledge of regulatory requirements and certification frameworks
- Proven success with similar clients or workplace projects
- Direct experience with your QMS software
You may find that qualified quality management consulting services are in high demand in your geographic area or vertical. Being selective is essential, so we recommend the use of creative recruitment strategies to find the right fit. Some of the smartest places to search for the right consulting services include:
- Asking peers, mentors, and colleagues for recommendations
- Attending industry events to network and meet talent
- Contacting certifying bodies such as the NQA or the American Society of Quality
- Exploring out-of-the-box channels for recruitment, such as social media
- Considering the use of remote talent for specific projects
- Asking your eQMS provider to recommend independent consultants or firms
- Inquiring if your eQMS vendor offers consulting or strategy services
How to Tell if You Really Need Quality Management Consulting Services
Quality management consulting services can provide a broad range of services to organizations in highly regulated industries, which ranges from compliance support to labor for an eQMS system import. Companies in pharma, medical devices, or life sciences fields may hire a quality management consultant for a long or short-term engagement during any phase of the product lifecycle.
If your organization has a defined need for support with compliance, eQMS, training, or CAPA, you should evaluate both traditional approaches to hiring or a consultant. Projects which have a tight deadline, a defined scope, or require sought-after expertise may be a strong use case for consulting services.
What if your organization needs help with creating or improving quality systems but doesn't know where to start? The right consultant may be able to provide broad support in assessing your current systems and design a QMS from the ground up, but it is still helpful to have a baseline understanding of your goals.
After working with countless firms in highly regulated industries, Qualio is a firm believer in the value of carefully selected quality management consulting services for a broad mix of use cases. However, we recommend that clients create a baseline and understand their existing systems before hiring to ensure the best outcomes possible.
Understand your current position before contacting a quality management consulting service. Get Your Quality Score by taking a short, insightful self-assessment quiz to learn how you stack up and opportunities for improvement.