Technical Design Risk Assessment

ISO 9001 Cl. 8.3 • CDM 2015 Reg. 9 — Risk assessment for CRGI’s engineering design activities

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Excel format for operational use — editable risk scores, additional hazards, print-ready

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Assessment Overview

This assessment addresses risks inherent in CRGI Solutions’ core engineering design activities including process design for food and pharmaceutical industries, structural calculations, control system design, 3D scanning and material selection. Where CRGI is appointed as Principal Designer under CDM 2015 Regulation 9, there is a statutory duty to identify, eliminate and control foreseeable risks to health and safety arising from the design. Design errors can have significant safety, financial and reputational consequences; CRGI maintains professional indemnity insurance to £2M to address residual liability. Supports HPOL02 (Quality Policy), HPROC06 (Design Process Control) and HPROC07 (Change Management).

Part 1a — Risk Assessment

#	Activity / Process	Foreseeable Hazard	Who / What Affected	Existing Controls	C	L	R	Exposure	New Controls & Further Action	C	L	R	Exposure
1	Design of process equipment for food industry	Design errors leading to contamination risk, non-compliance with food safety regulations, or equipment failure; incorrect material specification allowing corrosion or bacterial harbourage	End users of designed equipment; client production staff; consumers; CRGI reputation and professional indemnity	• Design review at stage gates • Independent design check procedure • Compliance with EHEDG and FDA guidelines • Material selection database	5	2	10	Moderate	• Mandatory independent design check by second engineer for all food-contact equipment • EHEDG compliance checklist for hygienic design • Material traceability certificates required • CDM designer risk register maintained per HPROC06	5	1	5	Low
2	CAD modelling of pharmaceutical manufacturing equipment	Modelling errors in clean room equipment, containment systems or HVAC design; incorrect dimensional tolerances leading to GMP non-compliance	Client pharmaceutical operations; patient safety (indirect); regulatory compliance; CRGI professional indemnity	• BIM/3D modelling standards • Clash detection routines • GMP design requirements checklist • Client design review gates	5	2	10	Moderate	• Automated clash detection at every model issue • Tolerance verification checklist for GMP-critical dimensions • Peer review of clean room classification boundaries • Design deviation log maintained and issued to client	5	1	5	Low
3	Structural engineering calculations	Errors in load calculations, foundation design or structural analysis; incorrect factors of safety; using outdated design codes	Construction workers during installation; building occupants; public safety; CRGI professional liability	• Calculation check by second engineer • Design code verification • Eurocodes and British Standards library maintained current • Professional indemnity insurance	5	2	10	Moderate	• Category 3 checking (independent third party) for safety-critical structures • Design code version verified at project start and recorded • Calculation software version logged • Annual CPD requirement for structural engineers	5	1	5	Low
4	Control system design for automated equipment	Logic errors in PLC programming, safety interlock failures, incorrect emergency stop circuitry; inadequate functional safety assessment	Client operators and maintenance staff; production equipment; end products	• Functional safety review • HAZOP/LOPA participation where applicable • Testing and commissioning plan • Client FAT/SAT procedure	5	2	10	Moderate	• IEC 61508/61511 functional safety lifecycle followed for SIL-rated systems • Independent V&V of safety-critical logic • Pre-commissioning simulation mandatory • CRGI to attend FAT as minimum, SAT where contracted	5	1	5	Low
5	3D scanning and survey accuracy	Measurement errors from poor scan registration, inadequate target placement, equipment calibration drift; errors propagated into design models	Design accuracy of all downstream deliverables; client decision-making based on as-built data; clash detection reliability	• Scanner calibration per HPROC11 • Registration tolerance targets set per project • Target placement best practice guide • Point cloud QA checks	4	3	12	Moderate	• Maximum registration error defined per project scope (≤2mm for process, ≤5mm for structural) • QA report issued with every scan deliverable • Calibration certificate current at time of scan (HREG12) • Re-scan protocol if tolerance exceeded	4	1	4	Low
6	Material selection for chemical processing equipment	Incorrect material grade for process conditions; corrosion under insulation; stress corrosion cracking; galvanic incompatibility; failure in service	Client operations staff; process safety; plant integrity; CRGI professional liability	• Material selection guide per process conditions • NACE/ASME material compatibility references • Client process data sheet review • Previous project lessons learned	5	2	10	Moderate	• Material selection recorded and justified in design report • Corrosion allowance calculations documented • Independent review for exotic alloys or unusual process conditions • Lessons learned database consulted at project start	5	1	5	Low

Risk Scoring Matrix — Likelihood × Consequence

Likelihood ↓ / Consequence →	1 Negligible	2 Minor	3 Moderate	4 Major	5 Catastrophic
5 Almost Certain	5	10	15	20	25
4 Likely	4	8	12	16	20
3 Possible	3	6	9	12	15
2 Unlikely	2	4	6	8	10
1 Rare	1	2	3	4	5

Very Low (1–3) Low (4–6) Moderate (7–12) High (13–16) Very High (17–25)

Escalation & Recording

Per HPROC01 (Risk Assessment Procedure): any hazard scoring High (13–16) or Very High (17–25) after existing controls must be escalated to the CEO for formal risk acceptance before work proceeds. All residual risks are recorded in HREG01 (Risk & Opportunity Register). OH&S hazards feed into HREG03 (Hazard Register) and environmental aspects into HREG02 (Environmental Aspects Register).

Part 1b — Briefing Record

Briefing Requirement

By signing below, I acknowledge that I have received a health and safety briefing on the topic(s) covered by this risk assessment. If the risk assessment is updated, the briefing of the changes must be recorded as a new entry.

First Name	Surname	Signature	Date
Dragos	Ciordas	Dragos Ciordas	23/02/2026
Sean	Ashton	Sean Ashton	23/02/2026
Jake	Davies	Jake Davies	24/02/2026
John	Noble	John Noble	24/02/2026