Got a single process — Internal Audit, CAPA, Design Control, Supplier Qualification, Calibration, whatever — that needs an independent read against the standard it should comply with? Send the work instructions and the data the process generates. Pick the standard. You get a written gap report with action items within two business days of receipt.
You know the CAPA system is slow. You know the Internal Audit program hasn't issued findings in two years. You know the Design Control package gets reviewed at the gate and signed off without anyone really checking. You don't need a full QMS audit to confirm that. You need a senior independent engineer to read the one process you're worried about — and the data that process is actually generating — and tell you specifically what's broken and what to do about it.
That's this service. One process. One standard. Two business days. Same engineer who runs every QESaaS engagement reads the work instructions, sample-reviews the records the process is supposed to be producing, and writes you a gap report you can take straight to the process owner.
Use it when a process is failing internal audits. Use it when a customer audit flagged something and you need an independent read before the corrective action commits. Use it when you suspect a process is theatre — documented and signed, but not actually doing the work the standard requires.
If you can name the process and you have a standard to measure it against — this is the service.
Internal Audit hasn't issued a Major in years. You want an independent read on whether the program is actually finding things or rubber-stamping.
Customer complained the CAPAs aren't closing on time. Or the regulator did. Need an independent read on the program before you respond.
Supplier qualification process inherited from a prior quality manager. Want to know if it actually qualifies suppliers, or just files paperwork.
Design Control process for medical or aerospace. Need a 21 CFR 820.30 / DO-254 read on whether the gates are actually controlling design.
A document review tells you what the procedure says. A process audit tells you whether the procedure is being followed. The difference matters.
Missing clauses. Conflicting language between Quality Manual and WIs. Outdated revision references. Standards-traceability gaps. All real findings, but all paper findings.
Records the procedure says should exist but don't. Steps the WI says should be signed off but aren't. Cycle times that drift past the procedure's stated limits. Process theatre — where the docs are clean but the process isn't actually being run.
You name the process. Send the docs and the records. I read both. You get back a written gap report on day two.
QESaaS is a credentialed lead auditor against the standards below. Other standards (AS9100, IATF 16949, ISO 17025, 21 CFR 211) are available on quote.
Other standards (AS9100, IATF 16949, ISO 17025, 21 CFR 211) supported on custom quote — same engineer, same review approach, longer turnaround based on scope. Email and ask.
The 2-business-day turnaround works because the scope is bounded — one process, one standard, fixed deliverable shape. Day one is process-flow mapping and records sampling. Day two is gap-write-up and report finalization.
Documents land. Process flow mapped against the standard's stated requirements. Sample plan drawn for the records review.
Sampled records reviewed for completeness, timing, sign-offs. Practice-vs-procedure delta documented per finding.
Each finding tagged Major / Minor / OFI per ISO 17021 conventions. Action items prioritized.
Gap report drafted, reviewed, signed by the engineer who did the work. No anonymous "an auditor" — same name on the byline as on the LinkedIn profile.
Engineer sign-off is non-negotiable. The methodology is published — clients can read what they're paying for before invoicing.
Knowing the limits is what makes the price quotable and the deliverable clean.
If any of the items below are what you actually need, this is not the right service. We'll tell you so on the scoping call before invoicing.
The questions that come up most often.
QMS Document Review reads the documents top-down — Quality Manual, Procedures, Work Instructions — against the standard. Process Audit reads one specific process bottom-up — WI + the records the process is supposed to generate — against the standard's requirements for that process. QMS Document Review tells you what your QMS says. Process Audit tells you whether one specific process is actually running the way the QMS says it should.
Any documented process with a Work Instruction and records the process is supposed to generate. Common examples: CAPA, Internal Audit, Management Review, Document Control, Change Control, Training, Supplier Qualification, Supplier Performance Review, Design Control (820.30, DO-254), Production Control, Calibration, Maintenance, Customer Complaint Handling. If you can name the process and point at the WI, we can audit it.
If we sign the engagement letter and you upload the documents and records on Monday before noon ET, you get the gap report by close of business Wednesday. If you upload Friday afternoon, you get it Tuesday. The clock starts when both the documents and the records land in the share and the engagement letter is signed — not when the scoping call is booked.
Depends on the process. For high-frequency processes (CAPA, Document Control, Training), a 30-record sample drawn across the 90-day window is typical. For low-frequency processes (Management Review, Internal Audit), we review every instance in the 90-day window. Sample plan is documented in the report so you can replicate it later.
That's a Major finding on its own — the process is documented but not running, or running but not generating the records the standard requires. The gap report says exactly that, with the standard clause cited. Most processes will have at least some records; complete absence is rarer than "records exist but are incomplete," which is its own category of finding.
Yes — and that's actually a common use case. Customer or regulator asks for an independent second look at a process your internal team just gave a clean bill of health. We bring fresh eyes and no internal political pressure. The two findings sets get compared in the review call — sometimes they agree, sometimes they don't, both outcomes are useful.
Mutual NDA before any documents or records change hands — one-page template available, or send yours. Records often contain customer or supplier names; we redact identifying information from the report's evidence references unless you specifically ask us to leave them visible. Documents are received via a secure share, stored only for the duration of the engagement, and deleted within 14 days of report delivery unless you ask us to retain them.
Sure — quoted as multiples of the base price with a small discount for shared overhead. Two processes is typically $1,200, three is $1,750, four is $2,250 (and at that point the QMS Document Review starts to make more sense). We'll size it on the scoping call.
Book a free 20-minute scoping call. We'll confirm the process scope, the standard, and the records you have available. If it's a fit, you'll get a one-page engagement brief and a 50% deposit invoice. If it's not, we'll tell you why and recommend the right path.