Compliance & Quality

Pilot wave 2 (M7). Impact: high. See the hub.

Current state (assumptions to validate)

Compliance & quality holds Prime Products’ license to operate in its regulated segments: ISO 22000 food-safety management for the bonded provisions and cold-chain business, quality-management certification underpinning defense/public tenders, certifications for the OHS training services arm (ISO 21001/29993-class — exact scope to confirm in discovery), plus hazmat/CBRN handling compliance, bonded-warehouse regulatory obligations (with logistics), and GDPR. Certifications are also commercial assets — tender eligibility depends on them.

Assumptions — to validate in discovery: small team ~2–4; management-system documentation in Word/PDF on file shares, version control by filename; audit prep is a periodic scramble collecting evidence (records, logs, training files) from every department; HACCP/temperature records partly paper; nonconformity and CAPA tracking in Excel; SOPs outdated relative to actual practice. Pain points: evidence collection effort, documentation drift from reality, audit findings repeating, single-person knowledge of “where everything is.”

Target AI-first operating model

By M12 the management system lives as a governed document set with an assistant over it: any employee can ask “what’s the procedure for receiving frozen goods?” and get the current SOP with citation. SOPs are drafted and updated by AI from process-owner interviews and actual practice notes, then approved by the quality manager. Audit prep becomes continuous: an agent maintains an evidence map per audit requirement and flags gaps monthly instead of pre-audit panic. Nonconformities are captured in structure and trend-analyzed. Certification decisions, CAPA approvals, and everything shown to an auditor remain human-owned.

AI use cases

Use case	Pain addressed	Data needed	Complexity	Impact	Pilot
SOP drafting/updating from process-owner interviews (transformation discovery doubles as input)	Documentation drift, drafting effort	Interview transcripts, existing SOPs, ISO clause references	M	H	Y
Audit-prep evidence collection: requirement→evidence mapping with gap flags	Pre-audit scramble, repeat findings	Standard requirements, records locations (SharePoint/SoftOne/paper scans)	M	H	Y
Compliance Q&A for all staff (procedures, HACCP rules, hazmat handling)	Procedures unknown/unread	Governed SOP corpus	L	H	N
Nonconformity/CAPA intake, drafting and trend analysis	Excel tracking, no learning loop	NC reports, complaint cases (from CS), CAPA history	M	M	N
Regulatory-change monitoring digests (food safety, hazmat, customs regs)	Manual scanning	External regulatory sources	M	M	N
Training-services compliance file assembly (per-course records for ISO 21001/29993-class audits)	Manual per-course file building	Training records, trainer quals, course materials	L	M	N

Process transformation opportunities

• Living documentation: SOP review triggered by actual process changes (fed by the transformation itself), not calendar; every AI-redesigned process in this program gets its SOP updated as part of the change.
• Continuous audit readiness: monthly evidence-gap report replaces pre-audit projects.
• NC/CAPA loop: structured intake (including from CS complaints) → trend review → preventive action, closing today’s open loop.
• Record digitization: paper HACCP/temperature/training records to scan-first capture.

Required data sources

• Management-system documents (Word/PDF shares → governed SharePoint library).
• ISO standard requirement lists; past audit reports and findings.
• Records across departments: HACCP/temperature logs (warehouse), training records (HR/training arm), calibration, supplier certs (procurement), complaint cases (CS).
• Paper records → scan pipeline.

Potential AI agents

• SOP Drafting Agent — drafts/updates procedures from interviews and change notes; quality manager approves every published version.
• Audit Evidence Agent — maintains requirement→evidence mapping and drafts gap reports; compliance officer validates before anything reaches an auditor.
• CAPA Drafting Agent — drafts nonconformity records and CAPA proposals; quality manager approves.

Automation opportunities

• n8n: monthly evidence-gap report; document-review-due reminders; NC intake form → register.
• Certificate/accreditation expiry alerts (company-level, shared logic with procurement’s supplier certs).

Required integrations

• SharePoint governed document library; records sources (SoftOne reads for traceability data, scan intake) — see integrations.

KPIs

KPI	Baseline	M12 target
Audit-prep effort (person-days per audit)	TBD (M2)	−50%
Evidence gaps found in monthly report vs by auditor	n/a	≥90% caught internally
SOPs current (reviewed within cycle)	TBD	100%
Repeat audit findings	TBD	0
NCs with completed CAPA on time	TBD	≥90%

Risks

• AI-drafted SOP diverges from regulatory requirement → clause-reference grounding; quality-manager approval is the certification-relevant act, unchanged.
• Auditors question AI involvement in the management system → document the human-approval chain itself as a controlled procedure; be transparent.
• Evidence mapping gives false assurance → agent flags are advisory; officer validation before audit reliance.

Training needs

• Compliance team: SOP-drafting workflow, evidence-agent validation (M6–M7).
• All staff: compliance Q&A assistant awareness (M8, via change plan).
• Process owners: “your process changed → your SOP updates” routine (M8+).

Deliverables

• Governed document library + compliance Q&A corpus.
• SOP drafting pilot (M7) leveraging discovery interviews; evidence-mapping system.
• NC/CAPA register replacing Excel; compliance KPI dashboard.

12-month execution milestones

Month	Milestone
M1–M2	Discovery: certification-scope inventory, documentation audit, records-location map
M3	Governed library structure; document migration begins
M5	Requirement→evidence map built for the nearest upcoming audit standard
M7	Wave-2 pilot: SOP drafting (from discovery interviews) + evidence gap reporting
M8	Pilot evaluation; compliance Q&A open to all staff
M9–M10	Agents in production; NC/CAPA register live
M11	Dry-run audit using the evidence map
M12	KPI review; continuous-readiness routine handed over