New — The Inspection Record: the 483 Observation Library and the first article. Join free →

Decision Trail Assessment · FSMA Edition

Your decisions. Tested against an inspector's questions.

Twenty questions across HACCP, FSMA preventive controls, cGMP, supply chain, traceability, and decision defensibility. Answer honestly against your real records. See exactly where your program stands if FDA walks in tomorrow.

How to take it: Work it against three real records from your plant — your last finished product release, your last CCP deviation, your last supplier non-conformance. Answer each question based on what you can actually produce today, not what your SOPs say you should produce. Results appear immediately at the end.

Progress 0 / 20 answered

Section 01 — Hazard Analysis (HACCP / FSMA)

Do you maintain a documented hazard analysis that identifies biological, chemical, and physical hazards for each product and process step?

Strong

Product-specific, step-level, scientifically justified

Partial

Generic or template-based

Weak

Missing or outdated

Is each identified hazard explicitly linked to a control (CCP or preventive control)?

Strong

One-to-one mapping documented

Partial

Some hazards mapped, gaps exist

Weak

No clear linkage

Section 02 — Critical Control Points

Are CCPs defined with validated critical limits (e.g., temperature, time, pH)?

Strong

Scientifically validated with documentation

Partial

Limits defined but not validated

Weak

No defined limits

Is CCP monitoring performed at defined frequencies and recorded in real time?

Strong

Real-time, timestamped records

Partial

Periodic or batch entry

Weak

Inconsistent or missing

Section 03 — Deviations & Corrective Actions

When a CCP deviation occurs, is there a documented corrective action tied to product disposition?

Strong

Clear action + disposition (hold/rework/discard)

Partial

Action documented, disposition unclear

Weak

No structured response

Can you demonstrate why a deviated product was released or rejected?

Strong

Decision reasoning documented at time of action

Partial

Reasoning inferred after the fact

Weak

No reasoning captured

Section 04 — Preventive Controls (FSMA)

Are process, allergen, and supply-chain preventive controls formally defined?

Strong

All three defined and implemented

Partial

Some controls defined

Weak

Not structured

Is there a documented recall plan that can be executed immediately?

Strong

Tested and time-bound (mock recall validated)

Partial

Exists but untested

Weak

Not defined

Section 05 — Supplier & Supply Chain Control

Are suppliers formally approved based on risk and documented criteria?

Strong

Risk-based approval with ongoing verification

Partial

Initial approval only

Weak

No structured approval

Q10

Do you verify incoming materials against defined specifications (e.g., CoA review)?

Strong

Systematic verification with records

Partial

Spot checks

Weak

Not consistently verified

Section 06 — Traceability

Q11

Can you trace a finished product lot to all raw materials within minutes?

Strong

Immediate traceability (<2 hours)

Partial

Manual reconstruction required

Weak

Cannot trace fully

Q12

Can you trace forward to all customers who received a specific lot?

Strong

Complete distribution traceability

Partial

Partial visibility

Weak

Gaps in records

Section 07 — cGMP Controls

Q13

Are sanitation procedures documented and consistently executed?

Strong

Logged, verified, and audited

Partial

Documented but inconsistently followed

Weak

Informal or missing

Q14

Are personnel trained and records maintained for food safety responsibilities?

Strong

Role-based training with records

Partial

General training only

Weak

No formal training records

Section 08 — Verification & Validation

Q15

Do you perform verification activities (e.g., calibration, environmental monitoring)?

Strong

Scheduled and documented

Partial

Irregular execution

Weak

Not performed

Q16

Are your control measures (CCPs, preventive controls) scientifically validated?

Strong

Documented validation studies

Partial

Assumed effective

Weak

No validation

Section 09 — Decision Control

Q17

For product release, is there a record showing who made the decision and what data they reviewed?

Strong

Explicit decision record exists

Partial

Decision inferred from signatures

Weak

No decision record

Q18

When accepting or rejecting raw materials, is the decision reasoning documented?

Strong

Evidence + reasoning captured at time of decision

Partial

Decision recorded without reasoning

Weak

No structured record

Section 10 — Inspection Readiness

Q19

Can you demonstrate, in real time, why a specific batch was considered safe?

Strong

Single, coherent record available

Partial

Requires multiple documents

Weak

Cannot demonstrate clearly

Q20

If inspected today, could you defend your decisions without reconstructing them?

Strong

Fully defensible from existing records

Partial

Some reconstruction required

Weak

Heavy reconstruction required

See your results.

Enter your name and email to see your score, your band, and an honest read of where your program sits. Your responses and contact are recorded so we can follow up if you'd like more depth.

Your name

Work email

Company (optional)

20 of 20 questions must be answered before results appear.

Your Decision Trail Score

0 / 40

Section breakdown

Section	Score

Your decisions. Tested against an inspector's questions.

See your results.

Section breakdown

Not sure which case file you need?