Why You Might Consider Fractional Quality Assurance Services Today.
Perhaps you’re a startup, or a small to mid-size company that’s hired a fractional CFO because you don’t need (or can’t afford) one full time.
This fractional CFO likely has extensive C-suite experience, and signs on temporarily to help you establish compliant accounting and billing practices and to guide your strategic financial decisions until you are ready for a full-time hire.
Fractional quality assurance works much the same way.
We’ll make sure you remain compliant by performing those routine maintenance tasks that you need to do but don’t have the time – or the skillset – to do.
Fractional QA Is a great way to get the expertise you need without breaking the bank – a huge help for companies vying for capital while simultaneously developing and launching a product.
What Can Fractional Quality Assurance Services Do for You?
Quite a lot, actually – namely taking the stress off you and your staff by performing these routine QMS maintenance tasks:
- Internal Audits
- Supplier Audits
- Supporting FDA / ISO:13485 Audits
- Management Review
- Supplier Qualifications and Performance Reviews
- CAPAs (Corrective and Preventative Actions)
- Complaint Investigation (and reporting if needed!)
- Nonconformance Reports
- Registration and Listing
Spoiler Alert: Some of these activities can’t be outsourced.
These tasks need to be done AT LEAST once a year (unless your QMS has some very creative justifications) but we know you don’t have the bandwidth to worry about whether you’re compliant. That’s where we come in.
You Can’t Outsource Management Responsibility. But You Can Delegate the Routine Tasks.
Though you can outsource quality activities, you can’t outsource management or executive responsibility for quality.
The quality buck stops with YOU, Ms/Mr CEO.
Even if you purchase an electronic quality management system, you are still ultimately responsible for the quality culture of your organization – and the quality of your products.
Quality management activities should not be stressful. But too often the quality procedures are written, then sit collecting dust while your team scratch their heads trying to figure out how to implement them: What content needs to go into management review? Where do we find an internal auditor? Do they need special qualifications? How do we qualify a supplier? How do we know if this supplier quality agreement is good enough?
Our fractional QA services take the guess work out of compliance because we KNOW what information is required in a management review, we KNOW when to open a SCAR, and we KNOW when to complete performance reviews.
You can feel secure knowing you’re working with knowledgeable, experienced QA consultants and enjoying the benefits of the same level of expertise you’d get from a full-time senior level employee.
Strategy Got You Stumped?
Download my FREE Business Market Assessment tool which walks you through the revenue vs. cost modeling calculations that can help you judge the market viability of your product – before you commit.
Then pick an open half hour on my calendar and we can chat about the best submission strategy for your product.