--- title: Home | Affirm8 description: Affirm8 builds quality cultures that run effortlessly, taking slow, reactive decisions and repeat issues to fast, audit ready world class quality functions image: https://www.affirm8.co.uk/hubfs/Affirm8%20(21%20x%2021%20mm)%20(2)-2.png --- [Skip to content](https://www.affirm8.co.uk#main-content) [![affirm8](https://www.affirm8.co.uk/hubfs/Affirm8/images/affirm8.svg "affirm8")](https://www.affirm8.co.uk/?hsLang=en-gb) - [How we work](https://www.affirm8.co.uk/the-a-grade-method) - [Case Study results](https://www.affirm8.co.uk/case-studys) - [What our clients said](https://www.affirm8.co.uk/what-our-clients-say) - [Free stuff!](https://www.affirm8.co.uk/free-stuff) X - [How we work](https://www.affirm8.co.uk/the-a-grade-method) - [Case Study results](https://www.affirm8.co.uk/case-studys) - [What our clients said](https://www.affirm8.co.uk/what-our-clients-say) - [Free stuff!](https://www.affirm8.co.uk/free-stuff) - [What makes us tick](https://www.affirm8.co.uk/your-momentum-specialists) - [Our Services](https://www.affirm8.co.uk/how-we-can-help) - [Testimonials](https://www.affirm8.co.uk/what-our-clients-say) - [Activate the Next Step](https://www.affirm8.co.uk/activate-the-next-step) - [Blogs](https://www.affirm8.co.uk/blog) ## **We Make Audit Readiness A Daily Habit,** **Not A Yearly Panic** ##### Affirm8 is the world's only Quality Culture Momentum™ specialists. We help medical device, supplement, cosmetic and pharma teams fix repeating quality issues for good and stay audit ready.  > Your free Always Audit Ready Diagnostic for quality and operations leaders. 15 minutes and a coffee later, you'll know exactly where you stand.  [Book your Free Always Audit Ready Diagnostic](https://craig-fo4jwq01.scoreapp.com/) ![Craig Jacobs](https://www.affirm8.co.uk/hs-fs/hubfs/Untitled%20design%20-%202026-06-18T210928.194.png?width=500&height=500&name=Untitled%20design%20-%202026-06-18T210928.194.png) --- **Life Sciences teams we have worked with** ![JazzPharmaceuticals](https://www.affirm8.co.uk/hs-fs/hubfs/Affirm8/images/JazzPharmaceuticals.png?width=271&height=45&name=JazzPharmaceuticals.png) ![2san](https://www.affirm8.co.uk/hs-fs/hubfs/Affirm8/images/2san.png?width=188&height=45&name=2san.png) ![Vitabiotics](https://www.affirm8.co.uk/hs-fs/hubfs/Untitled%20(200%20x%20100%20px).jpg?width=200&height=100&name=Untitled%20(200%20x%20100%20px).jpg) ![waymade](https://www.affirm8.co.uk/hs-fs/hubfs/Affirm8/images/waymade.png?width=212&height=45&name=waymade.png) ![BBI solutions](https://www.affirm8.co.uk/hs-fs/hubfs/Affirm8/images/solutions.png?width=180&height=45&name=solutions.png) --- > # ![quote](https://www.affirm8.co.uk/hubfs/Affirm8/images/quote.svg) Within just **90 days**, our QMS compliance rate increased from **48% to 98%.** This transformation made a significant difference to our quality operations. ![Untitled design (1)](https://www.affirm8.co.uk/hubfs/Affirm8/images/Untitled%20design%20(1).svg) > >  Chris, Production Manager — BBI Solutions  --- ## Why the same issues keep coming back ####  ![quote](https://www.affirm8.co.uk/hubfs/Affirm8/images/quote.svg) we are working harder than ever and still losing ground. The audits keep coming, the issues keep repeating, and the team is exhausted. ![Untitled design (1)](https://www.affirm8.co.uk/hubfs/Affirm8/images/Untitled%20design%20(1).svg) Our team hears a version of that every week. Sometimes it comes from a leader building a quality system from scratch. Sometimes from one with a regulator's findings sitting on the desk. Most often from a leader watching the same issues return every few months, costing money the budget cannot spare.    ###  **Most weeks look like this:** : **- No time to fix what you already know** **- A team learning quality on the job** **- Two people doing the work of five** **- Processes nobody follows because nobody understands them** **- A team that stopped believing change lasts** ### So This keeps happening: **- The same deviation logged three times this year** **- CAPA closed in March, issue back by September** **- Coaching on Monday, back to old habits by Friday** **- Green metrics, and a shop floor that disagrees**   ![Your QMS is not embedded](https://www.affirm8.co.uk/hs-fs/hubfs/you%20would%E2%80%99t%20driving%20looking%20in%20the%20mirror%20(3).png?width=548&height=548&name=you%20would%E2%80%99t%20driving%20looking%20in%20the%20mirror%20(3).png "Your QMS is not embedded") This means audits become the only time quality gets fixed. Then the cycle starts again, with a more tired team. Quality Culture makes good practice a daily reflex, so the right thing happens when nobody is watching. --- ## Compliance isn't complicated. You've been made to think it is. Affirm8 works beside your people, on your floor. We build the habits, coach your leaders, and give your team foundations they can run and grow long after we leave. Quality is a people business, so we build capability that stays with you.  ![We will not work in a silo](https://www.affirm8.co.uk/hubfs/We%20will%20NOT%20work%20in%20a%20silo%20%26%20disapear%20into%20a%20slide%20deck%20(1123%20x%201123%20px).png "We will not work in a silo") #### What working with Affirm8 gives you  **✔** The same deviation stops appearing on your list **✔** Operations brings you problems early, instead of hiding them **✔** A team that solves problems without waiting for you **✔** Processes short enough that new starters follow them **✔** Numbers that show you the cause, not just the score **✔** Audit week runs like any other week   Getting there costs you no extra people and no extra hours.  #### What Affirm8 will not do  - Pull your team off their day job \- Hand you fixes that come undone in months \- Work in a silo and disappear into a slide deck \- Slow you down with heavy governance  ##  Curious if you would pass the A-Grade benchmark? Book your free Always Audit Ready Diagnostic and get a clear read on your quality.  [Book your Free Always Audit Ready Diagnostic](https://www.affirm8.co.uk/enquire?hsLang=en-gb) --- ## What changed for our clients ![Craig Jacobs - chief momentum officer](https://www.affirm8.co.uk/hubfs/Untitled%20(3%20x%204%20in)%20(1).png "Craig Jacobs - chief momentum officer") ### **✔** Overdue deviations down to 5%, from 55%, in three months #### The backlog you keep apologising for at management review is gone. ### **✔ Operational quality up to 99.8%, from 65%, in twelve months.** #### The problems that used to reach your desk get solved before they get there. ### **✔** **Always audit ready in as little as 90 days.** #### **The audit letter arrives and your team carries on as normal.** --- ### **Fifteen minutes & a coffee later, then you know.** Most quality leaders come off this call surprised by what was causing the repeat issues. You will leave with: **✔️ The main things holding your quality back, named** **✔️ Your Always Audit Ready Diagnostic, a deeper read on the causes** **✔️ Quick wins you can start momentum on Monday** Keep all of it, whether or not you ever work with Affirm8. No pitch guaranteed. Our **Acceleration Agreement** also means we will unearth ways to speed up your quality improvements, or we work for free until we do. [Book your Free Always Audit Ready Diagnostic](https://www.affirm8.co.uk/enquire?hsLang=en-gb) --- The A-Grade Quality Culture Method™ **The The A-Grade Always Audit-Ready Accelerator™** Your 15-minute call is step one of five. Every client runs the same method, which is why the results repeat. ![activate-icon](https://www.affirm8.co.uk/hs-fs/hubfs/Affirm8/images/activate-icon.png?width=150&height=150&name=activate-icon.png) ### Activate A 15-minute call and a free diagnostic. You find out where your quality is losing ground before you spend a penny. ![Assess-icon](https://www.affirm8.co.uk/hs-fs/hubfs/Affirm8/images/Assess-icon.png?width=150&height=150&name=Assess-icon.png) ### Assess We go deeper and find the cause behind your repeat issues. You stop treating symptoms and start fixing what keeps bringing them back.     ![Affirm-icon](https://www.affirm8.co.uk/hs-fs/hubfs/Affirm8/images/Affirm-icon.png?width=150&height=150&name=Affirm-icon.png) ### Affirm We build a costed plan with priorities and daily habits attached. You walk into your budget conversation with numbers instead of hope.   ![Untitled design (77)](https://www.affirm8.co.uk/hs-fs/hubfs/Untitled%20design%20(77).png?width=500&height=500&name=Untitled%20design%20(77).png) ![Accelerate-icon](https://www.affirm8.co.uk/hs-fs/hubfs/Affirm8/images/Accelerate-icon.png?width=150&height=150&name=Accelerate-icon.png) ### Accelerate We run the plan and manage the work ourselves. Your team keeps doing their day job while the improvements are made.   ![Advance-icon](https://www.affirm8.co.uk/hs-fs/hubfs/Affirm8/images/Advance-icon.png?width=150&height=150&name=Advance-icon.png) ### Advance We keep the habits sharp with regular checks and leadership coaching. Your team holds the standard without you standing over them.   ![Untitled design - 2026-08-21T113004.073](https://www.affirm8.co.uk/hs-fs/hubfs/Untitled%20design%20-%202026-08-21T113004.073.png?width=240&height=240&name=Untitled%20design%20-%202026-08-21T113004.073.png) ### Acceleration Agreement Our Acceleration Agreement: after we assess, we will unearth ways to speed up your quality improvements, or we work for free until we do. [Start with step one](https://www.affirm8.co.uk/enquire?hsLang=en-gb) --- Free insights ## Quality Culture, straight from the field [More Articles](https://www.affirm8.co.uk/blog?hsLang=en-gb) [![How to get beyond human error as a root cause](https://www.affirm8.co.uk/hs-fs/hubfs/10-how-to-get-beyond-human-error-in-root-cause-analysis-square.png?width=352&name=10-how-to-get-beyond-human-error-in-root-cause-analysis-square.png)](https://www.affirm8.co.uk/blog/how-to-get-beyond-human-error-in-root-cause-analysis?hsLang=en-gb) Sept 24, 2026 - 1 Min Read ### [How do you get beyond “human error” in root cause analysis?](https://www.affirm8.co.uk/blog/how-to-get-beyond-human-error-in-root-cause-analysis?hsLang=en-gb) [![How to risk rank suppliers](https://www.affirm8.co.uk/hs-fs/hubfs/09-how-to-risk-rank-suppliers-square-1.png?width=352&name=09-how-to-risk-rank-suppliers-square-1.png)](https://www.affirm8.co.uk/blog/how-to-risk-rank-suppliers?hsLang=en-gb) Sept 24, 2026 - 1 Min Read ### [How do you risk-rank suppliers?](https://www.affirm8.co.uk/blog/how-to-risk-rank-suppliers?hsLang=en-gb) [![How to make management review more effective](https://www.affirm8.co.uk/hs-fs/hubfs/06-how-to-make-management-review-more-effective-square.png?width=352&name=06-how-to-make-management-review-more-effective-square.png)](https://www.affirm8.co.uk/blog/how-to-make-management-review-more-effective?hsLang=en-gb) Sept 24, 2026 - 1 Min Read ### [How do you make management review more effective?](https://www.affirm8.co.uk/blog/how-to-make-management-review-more-effective?hsLang=en-gb) [![What quality KPIs matter](https://www.affirm8.co.uk/hs-fs/hubfs/05-what-quality-kpis-should-life-sciences-manufacturers-track-square.png?width=352&name=05-what-quality-kpis-should-life-sciences-manufacturers-track-square.png)](https://www.affirm8.co.uk/blog/what-quality-kpis-should-life-sciences-manufacturers-track?hsLang=en-gb) Sept 24, 2026 - 1 Min Read ### [What quality KPIs should a life sciences manufacturer track?](https://www.affirm8.co.uk/blog/what-quality-kpis-should-life-sciences-manufacturers-track?hsLang=en-gb) --- ## "Fixing quality the week before an audit is like booking your holiday after the plane has taken off. The destination is already decided." #### We embed the habits and the ownership your team needs to be ready every day, so audits feel like any other day. Come and see how the world class teams do it. #### Book a 15-minute call to find what is holding your quality back and where momentum can start now. Guaranteed no pitch.                       ![](https://www.affirm8.co.uk/hs-fs/hubfs/Untitled%20design%20(81).png?width=518&height=345&name=Untitled%20design%20(81).png) ### What it looks like from the other side Quality leaders in medical devices, supplements and pharma who now run teams that welcome audits. Their words, not ours.   ![Chris Gregory](https://www.affirm8.co.uk/hs-fs/hubfs/Chris%20Gregory.jpg?width=800&height=800&name=Chris%20Gregory.jpg) ![quote](https://www.affirm8.co.uk/hubfs/Affirm8/images/quote.svg) ** Within just 90 days our QMS compliance rate increased from 48% to an impressive 98%. ** Chris Production manager, BBI Solutions ![Mike](https://www.affirm8.co.uk/hs-fs/hubfs/Untitled%20design%20(33).png?width=800&height=800&name=Untitled%20design%20(33).png) ![quote](https://www.affirm8.co.uk/hubfs/Affirm8/images/quote.svg) **In 90 days we had a fully documented quality management system and a clear implementation plan in place & on time. - their expertise made certification both achievable and straightforward.** Mike Strategic & Operations Director, 2San ![Tom](https://www.affirm8.co.uk/hs-fs/hubfs/Tom-3.jpg?width=220&height=220&name=Tom-3.jpg) ![quote](https://www.affirm8.co.uk/hubfs/Affirm8/images/quote.svg) **We reduced supplier onboarding by 48%, we now have more time.** Tom Senior Quality Specialist, Jazz Pharma ![Steve Bond](https://www.affirm8.co.uk/hs-fs/hubfs/Steve%20Bond.jpg?width=753&height=753&name=Steve%20Bond.jpg) ![quote](https://www.affirm8.co.uk/hubfs/Affirm8/images/quote.svg) **I cannot recommend them highly enough. The ability to simplify complex quality processes and drive tangible results is unmatched.** Steve Production manager, BBI Solutions ![Ayisha](https://www.affirm8.co.uk/hs-fs/hubfs/Untitled%20design%20(47).png?width=481&height=481&name=Untitled%20design%20(47).png) ![quote](https://www.affirm8.co.uk/hubfs/Affirm8/images/quote.svg) *The global structure is now positioned to deliver meaningful data, ensure compliance, and create a single global quality solution.* Ayisha Quality Systems Manager, Jazz Pharma Load More Quick Links - [Your Momentum Specialists](https://www.affirm8.co.uk/your-momentum-specialists) - [How We Can Help](https://www.affirm8.co.uk/how-we-can-help) - [The A-Grade Method](https://www.affirm8.co.uk/the-a-grade-method) - [Outcomes That Matter](https://www.affirm8.co.uk/what-our-clients-say) information - [Blogs](https://www.affirm8.co.uk/blog) - [Activate the next step](https://www.affirm8.co.uk/activate-the-next-step) - [Terms & Conditions](https://www.affirm8.co.uk/terms-conditions) - [Privacy Policy](https://www.affirm8.co.uk/privacy-policy) Contact Details EMAIL: [enquiry@affirm8.co.uk](mailto:enquiry@affirm8.co.uk) PHONE: [07870407102](tel:07870407102) Office Address: Affirm8 Consultancy Ltd, Ashford, Kent, United Kingdom Follow Us - [LinkedIn](https://www.linkedin.com/company/affirm8) - [YouTube](https://www.youtube.com/) Copyright © 2026 Affirm8. All Right Reserved. [![Quality Assurance Consultancy](https://www.affirm8.co.uk/hs-fs/hubfs/Color%20logo%20-%20no%20background-Apr-25-2025-12-53-55-5608-PM.png?width=500&height=378&name=Color%20logo%20-%20no%20background-Apr-25-2025-12-53-55-5608-PM.png "Quality Assurance Consultancy")](https://www.affirm8.co.uk/?hsLang=en-gb) VAT Number: 420090057 ```json { "@context" : "https://schema.org", "@id" : "https://www.affirm8.co.uk/#organization", "@type" : "ProfessionalService", "address" : { "@type" : "PostalAddress", "addressCountry" : "GB", "addressLocality" : "Ashford", "addressRegion" : "Kent" }, "alternateName" : "Affirm8", "areaServed" : { "@type" : "Country", "name" : "United Kingdom" }, "description" : "Affirm8 Consultancy Ltd is a quality culture consultancy for life sciences organisations, specialising in pharmaceuticals, supplements, medical devices and cosmetics. 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He founded Affirm8 Consultancy in 2022 and developed the A-Grade Quality Culture Method.", "hasCredential" : { "@type" : "EducationalOccupationalCredential", "credentialCategory" : "CQP MCQI" }, "jobTitle" : "Founder and Chief Momentum Officer", "name" : "Craig Jacobs", "sameAs" : [ ], "url" : "https://www.affirm8.co.uk/about", "worksFor" : { "@id" : "https://www.affirm8.co.uk/#organization" } } ``` ```json { "@context" : "https://schema.org", "@id" : "https://www.affirm8.co.uk/#faq", "@type" : "FAQPage", "mainEntity" : [ { "@type" : "Question", "acceptedAnswer" : { "@type" : "Answer", "text" : "Affirm8 Consultancy is a quality culture consultancy for life sciences organisations, working across pharmaceuticals, supplements, medical devices and cosmetics. It helps manufacturers reduce quality costs, resolve recurring quality issues through root cause analysis, and build sustainable quality culture using its proprietary A-Grade Quality Culture Method." }, "name" : "What does Affirm8 Consultancy do?" }, { "@type" : "Question", "acceptedAnswer" : { "@type" : "Answer", "text" : "Affirm8 Consultancy was founded by Craig Jacobs, a CQP MCQI-qualified quality professional with over 20 years of experience in life sciences quality assurance." }, "name" : "Who founded Affirm8 Consultancy?" }, { "@type" : "Question", "acceptedAnswer" : { "@type" : "Answer", "text" : "Affirm8 works with life sciences manufacturers across pharmaceuticals, nutritional supplements, medical devices and cosmetics, supporting both brand owners and their contract manufacturing organisations (CMOs)." }, "name" : "What industries does Affirm8 work with?" }, { "@type" : "Question", "acceptedAnswer" : { "@type" : "Answer", "text" : "The A-Grade Quality Culture Method is Affirm8's proprietary five-stage framework for building quality culture in life sciences organisations: Activate, Assess, Affirm, Accelerate, Advance." }, "name" : "What is the A-Grade Quality Culture Method?" }, { "@type" : "Question", "acceptedAnswer" : { "@type" : "Answer", "text" : "In one diagnostic engagement, Affirm8 identified £3.59M in annual quality cost and £2.09M in recoverable savings for a life sciences manufacturer, equivalent to £11.30 returned for every £1 invested. In another engagement, a client reduced open quality deviations from 280 (60% overdue) to 15 within six months." }, "name" : "What results has Affirm8 delivered for clients?" }, { "@type" : "Question", "acceptedAnswer" : { "@type" : "Answer", "text" : "Affirm8 Consultancy Ltd is based in Ashford, Kent, United Kingdom, and works with life sciences clients across the UK." }, "name" : "Where is Affirm8 Consultancy based?" } ] } ```