The Binder Nobody Opens
A quality manual exists — three hundred pages, written for a different company, last touched during the last audit. Nobody on the floor has read it. A manual nobody uses is decoration, not a system.
Services · Quality Systems
Your QMS, written for you.
Most small and mid-size manufacturers don't need QMS advice — they need the actual system: the quality manual, the SOPs, the CAPA and change-control machinery, written for how they operate and implemented with their team. That's this engagement. Fixed scope, agreed up front, done-for-you.
WHY IT EXISTS
Advice doesn't survive an inspection. Systems do.
Facilities fail inspections on the same handful of quality-system gaps: undocumented processes, CAPA that never closes, records nobody can retrieve. We build the system that closes them.
Done for youWe write the manual, the SOPs, and the procedures — not a template pack for you to fill in on weekends.
Fixed scopeWhat's included, what it costs in effort, and when it lands — agreed before we start. No hourly meter.
OwnableBuilt for your team to run after we leave: plain language, sized to your operation, trained into your people.
THE PATTERN
What broken quality systems look like.
Four failure modes we see across cannabis, food, supplement, cosmetics, and pet food facilities.
SOPs Nobody Follows
Procedures describe an ideal process that doesn't match how the work actually happens. Operators follow tribal knowledge; the SOP follows fantasy. The first thing an investigator notices is the gap between the two.
CAPA That Never Closes
Deviations get logged and then sit — no root cause, no actions, no effectiveness checks. An open CAPA log with nothing closed is worse than no log at all: it's documented evidence of a system that doesn't work.
Inspection-Ready on Paper Only
Records exist but can't be retrieved, training files are months behind, change control is a group chat. The system looks complete until someone asks for one record — and then it isn't.
WHAT'S INCLUDED
The full system, built with your team.
Every engagement includes the working core below, sized to your operation — a 12-person edibles kitchen doesn't get the same system as a 200-person co-packer.
Quality Manual
The top-level document: your quality policy, scope, organization, and how the whole system fits together — written for your facility, not copied from a template.
SOP Library Development
Procedures for your actual processes — production, packaging, warehousing, sanitation, maintenance — drafted from walkthroughs and interviews, then reviewed with the people who do the work.
Document & Record Control
Numbering, approval, revision, retention, and retrieval: the machinery that keeps documents current and records findable when an investigator asks.
CAPA Program
Deviation handling, root-cause investigation, corrective and preventive actions, and effectiveness checks — with the discipline to actually close things.
Change Control
Evaluation, approval, and implementation of changes to processes, equipment, suppliers, and documents — with impact assessment built in.
Management Review
The periodic review routine: what leadership looks at, how often, and what decisions come out of it — so the system improves instead of fossilizing.
Internal Audit Program
Your own audit schedule, checklists, and reporting — so you find your gaps before an inspector or customer does.
Training & Qualification Records
Training matrices, qualification records, and the routine that keeps them current as people join, move, and leave.
MAPPED TO YOUR REGULATION
One system, your rulebook.
The QMS skeleton is the same; the regulatory flesh differs by industry. We map every element to the rulebook that governs you.
Dietary Supplements
Built around 21 CFR Part 111: master manufacturing and batch production records, component identity testing, and laboratory controls.
Food & Beverage
Built around 21 CFR Part 117 and FSMA: food safety plan, preventive controls, supply-chain program, and recall procedures. GFSI-benchmarked schemes (SQF, BRCGS, FSSC 22000) supported as done-for-you programs.
Pet Food
Built around 21 CFR Part 507: current good manufacturing practice for animal food, including preventive controls and qualified-individual concepts.
Cosmetics
Built around MoCRA: safety substantiation records, GMP-aligned manufacturing records, and adverse-event procedures.
Cannabis
Mapped to your state's GMP requirements — cannabis rules vary state to state, so we build to the rulebook your license actually answers to.
One boundary, stated plainly: we don't serve pharma, biopharma, or medical device companies. Five industries, deeply — not fifteen, thinly.
Explore all servicesHOW IT RUNS
Written with you, not at you.
A system your team didn't help build is a system your team won't use. The method keeps them in the room.
01 · Scope
We agree exactly what's included, what it takes, and when it lands — before anything starts. Fixed scope, no hourly meter.
02 · Build
Walkthroughs and interviews with the people who do the work. We draft; your team reviews. Procedures describe reality, not fantasy.
03 · Implement
Rollout with your team: training, records, routines. The system goes live while we're there to steady it — not after we've left.
04 · Handoff
Your team owns it. We verify the system is alive — records being created, CAPA closing, audits happening — before we step back.
An honest note: we write quality systems; we don't certify them. No consultant can grant ISO certification — that's a certification body's job. What we build is designed to pass their audits.
THE ASSESS → BUILD PATH
Start with the assessment.
If you don't know how big the gap is, don't buy the build yet. The four-week GMP Readiness Assessment — the Assess step — maps every gap first; this engagement, the Build, closes them.
QUESTIONS
QMS writing, answered.
What does a QMS program include for a supplement, food, or cannabis facility?
The working core: a quality manual, an SOP library sized to your operation, document and record control procedures, a CAPA program, change control, management review, an internal audit program, and training and qualification records — each mapped to your regulation (21 CFR Part 111, 117, or 507, state cannabis rules, or MoCRA).
How is QMS writing different from a GMP readiness assessment?
The assessment finds the gaps; QMS writing closes them. The four-week assessment delivers a gap register and remediation roadmap — this engagement builds the actual system: the manual, the SOPs, the CAPA and change-control machinery your team runs every day.
Do you work with startups that have no quality system at all?
Yes — that's the core use case. Most of our QMS builds start from a blank page: no manual, scattered SOPs, tribal knowledge. We build the system around how you actually operate, then formalize it.
How long does it take to write and implement a QMS?
It depends on the size and complexity of your operation, so we agree scope and timeline up front before anything starts. For most small-to-mid facilities it lands in weeks, not quarters — and if yours won't, we tell you during scoping, not halfway through.
Do you serve pharma or medical device companies?
No. We serve five industries deeply — cannabis, food & beverage, dietary supplements, cosmetics, and pet food — and deliberately stay out of pharma, biopharma, and medical devices.
Start with a free QMS conversation.
Confidential, no pressure. We'll walk through your top quality-system gaps and give you an honest read on whether a written QMS is the right next step.