Case Studies
Art. #001 - Rotary PET Filler
BLOCK: Food & Beverage (c) 2025 AI Safe · AI Safe Academy
Art. #001 - Rotary PET Filler
Food & Beverage · Sleeve entanglement in the infeed starwheel
CASE INFORMATION
|
Industry |
Equipment |
Hazardous Event |
HRNt / Level |
|---|---|---|---|
|
Food & Beverage |
Rotary PET Filler |
Sleeve entanglement in the infeed starwheel |
831.4 - INTOLERABLE |
CASE CONTEXT
A cleaning operator reaches into the rotating starwheel during a CIP purge without locking out the drive.
Assessment performed with AI Safe (AI Safe Academy), HRNt cross-standard correlation engine ISO 13849-1 / IEC 62061. Audit criteria per CPMSS/CLAMSS.
HRNt CALCULATION - AI Safe Academy
|
HRNt = Sqrt( HRN x HRP ) x f(t) x fE HRN = GS(10) x FE(4) x PO(6) x NP(2) = 480 HRP = GS(10) x FE(4) x PO(6) x PA(6) = 1440 HRNt = Sqrt(480 x 1440) x 1.0 x 1.0 = 831.4 Risk Level: INTOLERABLE |
|---|
HRNt PARAMETERS
|
Parameter |
Value |
Level |
Rationale |
|---|---|---|---|
|
GS - Severity |
10 |
Fatality/Serious |
Scale: 0.1 -> 15 (per clinical description) |
|
FE - Frequency |
4 |
Continuous/Frequent |
Scale: 0.5 -> 5 (normal operation and maintenance) |
|
PO - Occurrence |
6 |
Probable/High |
Scale: 0.033 -> 15 (uncontrolled conditions) |
|
NP - Persons |
2 |
2 person(s) exposed |
Scale: 1 -> 12 (direct danger zone) |
|
PA - Avoidance |
6 |
Impossible |
Scale: 1 -> 15 (closing speed and detection) |
IEC 62061 - CLASS (Cl -> SIL)
Cl = Se x (Fr + Pr + Av) = 4 x (4 + 4 + 5) = 52 Result: SIL 3 (Se=4: severity | Fr=4: freq. | Pr=4: probability of occurrence | Av=5: avoidance)
CROSS-STANDARD CORRELATION
|
Standard |
Method / Parameters |
Result |
SCS Requirement |
|---|---|---|---|
|
ISO 13849-1 |
S2 . F2 . P2 - Risk Graph |
PLr=d |
PFHd per required PLr |
|
IEC 62061 |
Se=4 . Fr=4 . Pr=4 . Av=5 -> Cl=52 |
SIL 3 |
PFH per calculated SIL |
|
RIA TR R15.306 |
S3 . E2 . A3 - Risk Matrix |
INTOLERABLE |
Safeguarding required |
|
ANSI B11.0 |
Risk Score - RC-3 |
RC-3 |
Control per RC-3 |
|
CSA Z460-20 |
MCEP - MODE 2 |
MODE 2 |
Energy isolation |
|
HRNt (AI Safe) |
GS x FE x PO x NP/PA = 831.4
|
831.4 - INTOLERABLE |
Risk reduction required |
CONTROL MEASURES — HIERARCHY
|
# |
Hierarchy Level |
Description |
Standard |
|---|---|---|---|
|
1 |
Elimination / Redesign |
Redesign maintenance access outside the danger zone in accordance with ISO 12100 |
ISO 12100 |
|
2 |
Engineering — SRP/CS |
Install a safety-related control system with PLr=d, PFHd verified by instrument |
ISO 13849-1 |
|
3 |
LOTO — CSA Z460-20 |
MODE 2 energy-control procedure with an individual padlock per worker |
CSA Z460-20 |
|
4 |
Signage / Admin. |
ANSI Z535 signage, written procedures, documented annual training |
ANSI Z535 |
AUDIT CRITERIA — CPMSS / CLAMSS
|
The CPMSS/CLAMSS auditor must verify: • Implementation of an SRP/CS with PLr=d verified by instrument through measured PFHd. • MODE 2 LOTO procedure with individual padlocks, training, and a documented record in AI Safe. • HRNt assessment updated in the AI Safe platform with the signature of a CPMSS-certified assessor. • Issue a MAJOR finding if the target residual risk is not achieved (HRNt < 50). |
|---|
TECHNICAL CONCLUSION
The multi-standard assessment performed with AI Safe (AI Safe Academy) determines an HRNt = 831.4 (INTOLERABLE) for the scenario of sleeve entanglement in the infeed starwheel of a Rotary PET Filler. Implementing the indicated measures — including an SRP/CS with PLr=d and a MODE 2 LOTO procedure — will reduce the risk to a Controlled level (HRNt < 50). The convergence of ISO 13849-1 and IEC 62061 confirms the diagnosis. Document in the AI Safe platform and validate with a certified CPMSS/CLAMSS auditor.
(c) 2025 AI Safe · AI Safe Academy | Article #001 | Food & Beverage | HRNt: AI Safe proprietary methodology
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