(Controlled under QA-DOC-001; QA-GOV-001; QA-REL-001; PROD-MMR-001)
I am a specification.
I live between two worlds: Sales, where everything is possible, and Operations, where physics and the FDA have opinions.
Sales calls me “flexible.” QA calls me “missing.” Production just calls me “the reason I drink.”
No one ever remembers when I was created — probably during a Teams call where half the cameras were off and someone said,
“We’ll finalize it after the client signs the SOW.”
Spoiler alert: they didn’t.
I was conceived the moment a Sales rep promised the client:
“Oh yes, we can totally make that — vegan, keto, sugar-free, blue, shelf-stable, and made of dreams.”
At that point, I existed only in spirit — no formula, no label claims, no micro specs, just a PowerPoint and confidence.
By the time the SOW reached QA, it was like receiving a treasure map written in hieroglyphics and red flags:
“Ingredient TBD”
“Specs TBD”
“Packaging TBD”
“Ship date: next Friday.”
The only thing not “TBD” was the client’s impatience.
Then Operations got involved — reluctantly, like a foster parent who just found out the kid comes with no birth certificate.
Production asked, “What’s the blend density?”
Sales replied, “Just make it fit in the capsule.”
QA asked, “What’s the potency tolerance?”
Sales replied, “Close enough for marketing.”
It’s like watching two people play tennis on different courts — one using rackets, the other using a flamethrower.
Somewhere between “customer delight” and “cGMP compliance,” I was supposed to become a real specification. Instead, I became a legend — spoken of in meetings, but never seen in the wild.
Eventually, QA finds me — or at least the idea of me — buried in someone’s inbox under “Final_Final_Spec_v3_REALLY_FINAL.xlsx.”
They try to validate me. They try to standardize me. They try to make me behave according to 21 CFR 111.70, which clearly states that specifications must exist before manufacturing, not during existential panic.
Sales calls QA “rigid.”
QA calls Sales “delusional.”
Production calls both “the reason my weekend got canceled.”
Then comes the audit.
The auditor asks:
“Can you show me the finished product specifications for this SKU?”
Sales says, “We have them in marketing.”
Production says, “We follow the batch record.”
QA says, “The batch record follows the specification.”
The auditor says, “Can I see the specification?”
Everyone looks at each other like they’re in an episode of CSI: GMP Edition.
I’m nowhere to be found, but my absence echoes louder than a nonconformance.
CAPA #347 – “Lack of defined product specifications prior to production.”
Root cause: Sales optimism.
I am supposed to be a written, controlled document that defines the product’s identity, purity, strength, composition, and limits on contaminants (per 21 CFR 111.70 and NSF/ANSI 455-2 §4.5.1–§4.5.63).
I am the parent of the Master Manufacturing Record (PROD-MMR-001), the reference for QC testing, and the proof QA uses for release under QA-REL-001.
Instead, I’m often written in panic font two days before shipment, after the first batch “doesn’t quite match the label.”
Eventually, everyone realizes I’m not the enemy — I’m the peace treaty. When I’m defined up front, Sales sells reality, Production builds confidence, QA sleeps, and clients trust.
Documented in the QMS, I become immortal — validated, version-controlled, and auditable without fear or caffeine.