This is a ready-to-use punch list (also called a snag or deficiency register) for FAT and SAT. It is the connective tissue between the vendor’s shop, your site, and qualification, and it is one of the first artifacts an auditor asks for. Replace every <<FILL: ...>> placeholder, keep it live from the first FAT observation through IQ start, and never close an item without evidence. A filled specimen follows. This is educational reference content, not regulatory advice.
Header
| Field | Entry |
|---|---|
| Register number | <<FILL: LOG-ID>> |
| Equipment / system and tag | <<FILL>> |
| Vendor / PO | <<FILL>> |
| FAT date(s) | <<FILL>> |
| SAT date(s) | <<FILL>> |
| Register owner | <<FILL: C&Q engineer>> |
Classification rules (agree before the test, record here)
| Class | Definition | Effect on milestone |
|---|---|---|
| Critical | Affects safety, GMP, data integrity, or prevents core function | Blocks ship at FAT and blocks IQ start at SAT |
| Major | Significant defect that must be fixed but does not alone block the milestone if a controlled plan exists | Milestone allowed only with approved disposition and owner |
| Minor | Cosmetic or low impact | May ship / proceed with item open and tracked |
Field definitions
| Field | Purpose |
|---|---|
| Item no. | Unique ID, traceable across FAT and SAT (e.g. FAT-012, SAT-003) |
| Date raised | When observed |
| Raised by | Who found it |
| Description | The defect, specific and factual |
| Reference | Drawing, step, spec, or requirement affected |
| Class | Critical / Major / Minor |
| Owner | Vendor or site, named |
| Agreed action | What will be done |
| Target close | Date |
| Closure evidence | Retest result, revised drawing, replaced part with cert, or photo |
| Verified by / date | Person confirming closure, independent of the fixer |
| Status | Open / Closed / Deferred (to item no.) |
Register
| Item no. | Date | Raised by | Description | Reference | Class | Owner | Agreed action | Target close | Closure evidence | Verified by / date | Status |
|---|---|---|---|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | Open |
Carry-forward and sign-off
- Every open FAT item carries to SAT; every open SAT item carries to commissioning/IQ with a documented disposition. Nothing vanishes.
- The register is reconciled at FAT close (ship decision), SAT close (IQ-start decision), and IQ start.
| Reconciliation point | Open critical | Open major | Open minor | Decision | Signed / date |
|---|---|---|---|---|---|
| FAT close (ship) | <<FILL: 0 to ship>> | <<FILL>> | <<FILL>> | <<FILL: ship / hold>> | <<FILL>> |
| SAT close (start IQ) | <<FILL: 0>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Filled specimen
Example for a filling skid, showing an item deferred at FAT and closed at SAT, and a critical item blocking ship until retested.
| Item no. | Date | Raised by | Description | Reference | Class | Owner | Agreed action | Closure evidence | Verified by / date | Status |
|---|---|---|---|---|---|---|---|---|---|---|
| FAT-012 | 12-Jun | A. Kern | High-pressure interlock tripped 0.4 bar high | Step 7.8 | Critical | Vendor | Re-tune, retest | Step 7.8 re-executed, tripped at setpoint, photo signed | R. Diaz 12-Jun | Closed |
| FAT-019 | 12-Jun | A. Kern | HMI batch screen shows temperature in F, URS requires C | URS-114 | Major | Vendor | Correct config, retest | SW v2.3.1 loaded, screen verified C | R. Diaz 13-Jun | Closed |
| FAT-024 | 13-Jun | A. Kern | Hopper guard paint scratched | GA-07 | Minor | Vendor | Touch up at site | Carried to SAT-003 | n/a | Deferred |
| SAT-003 | 03-Jul | R. Mehta | Hopper guard paint scratch (from FAT-024) | GA-07 | Minor | Vendor | Touch up | Photo of repaired guard, signed | R. Mehta 03-Jul | Closed |
| SAT-007 | 03-Jul | R. Mehta | Compressed air dew point cert not provided | URS-088 | Major | Site | Obtain utility cert | Utility cert filed, value in class | R. Mehta 04-Jul | Closed |
FAT close reconciliation: 0 open critical, 0 open major, 1 open minor (FAT-024 deferred with plan). Ship authorized. SAT close: 0 open critical, 0 open major, 0 open minor. IQ start authorized.
The discipline the specimen shows: FAT-012 (critical) blocked ship until retested and signed by someone other than the person who fixed it; FAT-024 (minor) was allowed to ship but was explicitly carried to SAT-003, not silently dropped; every closure has objective evidence, not a promise.
Common inspection findings this log prevents
- Items marked “closed” with no retest, drawing, part cert, or photo behind the closure.
- A critical or major defect informally carried past a milestone without a disposition.
- Items that appear at FAT and quietly vanish before SAT with no trace.
- Closure signed by the same person who performed the fix, with no independent verification.
How to adapt this log
- Record your agreed classification rules at the top before witnessing begins.
- Use a numbering scheme that shows the source event (FAT-nnn, SAT-nnn) and survives carry-forward.
- Reconcile at each milestone and record the ship / start-IQ decision with a signature.
- Cross-reference deviations where a punch item also meets your deviation threshold.