Audit Report Entry for LEGAMI S.R.L
Audit Type:
1St Stage
Initial
Recertification
SV1
SV2
Strength Point:
- Design verification and validation process - Quality Control Process - Documentation system - Using of software
Audit Objectives:
To ensure the management system is complying with the ISO 9001:2015 requirements
Area for Improvement:
• The IA audit program needs to be enhanced. • The mints of meeting need to be enhanced.
Observation:
NA
Minor NCR:
NA
Major NCR:
NA
Man Days:
Team Leader Recommandations:
The company shows implementation of effective quality management system according to ISO 9001:2015
Audit Findings
Clause No.
Requirements/Departement
Evidence
Result
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Understanding the organization and its context
Board meeting minutes Oct 2024, SWOT review Q4 2024 (Nicola Lazzari, Giulia Romano)
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Understanding the organization and its context
Board meeting minutes Oct 2024, SWOT review Q4 2024 (Nicola Lazzari, Giulia Romano)
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Understanding needs and expectations of interested parties
Stakeholder analysis Nov 2024, customer survey results Dec 2024 (Giulia Romano)
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Determining the scope of the QMS
QMS scope document (rev. Dec 2024), no exclusions (Natascia Ghilardi)
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QMS and its processes
Process map, KPI report Oct–Dec 2024, monthly analysis (Marco Bianchi, Matteo Greco, Paolo Ricci)
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Leadership and commitment
Top management attendance in opening/closing & MR Jan 2025 (Nicola Lazzari, Natascia Ghilardi)
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Quality policy
Policy review Dec 2024, environmental commitment visible (Natascia Ghilardi)
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Organizational roles, responsibilities, authorities
Job descriptions updated Nov 2024 for key roles; sample: Junior Quality Specialist (Federica Moretti), Magazziniere Capo (Matteo Greco)
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Actions to address risks and opportunities
Risk assessment review Dec 2024, Board approval (Nicola Lazzari, Alessandra Ferri, Serena Rinaldi)
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Quality objectives and planning to achieve them
Objectives plan 2025, improvement in logistics process (lead time Oct–Dec 2024) (Paolo Ricci, Serena Rinaldi)
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Planning of changes
Change management register, change review meeting Jan 2025 (Natascia Ghilardi, Marco Bianchi, Chiara Villa)
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Resources
Resource allocation plan Nov 2024, outsourcing records, warehouse equipment list (Alessandra Ferri, Matteo Greco) Preventive maintenance of production machinery evidenced as follows: • Heidelberg Speedmaster XL 75 Printing Press • Model: XL 75-5+L • Serial No.: HSM75-2021-0084 • Inspection/PM Log Form: FM-MNT-001 • Last Full Preventive Maintenance: 10/12/2024 (mechanical, lubrication, and print quality calibration by Eng. Serena Rinaldi) • Visual Safety Inspection: 20/11/2024 (safety guards, emergency stops) • UV Dryer Check: 10/12/2024 • Polar 92 XT Paper Cutter • Model: 92 XT • Serial No.: POL92-2019-341 • Inspection/PM Log Form: FM-MNT-002 • Blade Change & Alignment: 18/11/2024 (by Matteo Greco) • Hydraulic System Check: 18/11/2024 • Safety Interlock Test: 18/11/2024 • MBO K80 Folding Machine • Model: K80-4/4 • Serial No.: MBO80-2020-112 • Inspection/PM Log Form: FM-MNT-003 • Roller & Belt Cleaning: 05/12/2024 • Electrical Panel Inspection: 05/12/2024 • Noise/Vibration Check: 05/12/2024 • BOBST NOVACUT 106 E Die Cutter • Model: NOVACUT 106 E • Serial No.: BOB106-2022-046 • Inspection/PM Log Form: FM-MNT-004 • Die Alignment & Pressure Test: 12/12/2024 (by Chiara Villa, supervised by Serena Rinaldi) • Oil & Filter Change: 12/12/2024 • Safety Sensor Calibration: 13/12/2024 • Muller Martini Presto II Saddle Stitcher • Model: Presto II • Serial No.: MMPII-2021-077 • Inspection/PM Log Form: FM-MNT-005 • Binding Head Lubrication: 28/11/2024 • Conveyor Belt Check: 28/11/2024 • Emergency Stop Test: 28/11/2024 All maintenance records reviewed and signed off by Serena Rinaldi (Maintenance), with digital copies stored in the QMS system. No overdue items. alibration of key equipment evidenced as follows: • Mettler Toledo Precision Weighing Scale o PN: MT-PL1502E, SN: 21PL1502-0234 o Calibration certificate: CAL-2024-1147 o Last calibration date: 03/11/2024 o Calibrated by: Accredia-accredited lab (CertLab Srl) o Next due date: 03/11/2025 • Mitutoyo Digital Micrometer o PN: MDC-25SX, SN: MTY-0192847 o Calibration certificate: CAL-2024-1102 o Last calibration date: 10/12/2024 o Calibrated by: CertLab Srl o Next due date: 10/12/2025 • X-Rite i1Pro2 Spectrophotometer (for color measurement in print) o PN: XR-i1PRO2, SN: XR-2021-1138 o Calibration certificate: CAL-2024-1192 o Last calibration date: 15/10/2024 o Calibrated by: Colormetrix Srl o Next due date: 15/10/2025 • Mitutoyo Digital Caliper o PN: CD-15APX, SN: MTY-0011275 o Calibration certificate: CAL-2024-1119 o Last calibration date: 19/11/2024 o Calibrated by: CertLab Srl o Next due date: 19/11/2025 All calibration certificates are available and reviewed in the QMS system (folder: /QMS/Calibration/2024), signed and verified by Serena Rinaldi (Responsabile Manutenzione). No overdue calibrations found.
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Competence
Training records: Excel training 10/10/2024, 24/11/2024; Job descriptions reviewed Jan 2025 (Federica Moretti, Chiara Villa, Serena Rinaldi)
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Awareness
Employee interviews and awareness checks Dec 2024 (all departments: incl. warehouse, design, maintenance)
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Communication
Product catalog Nov 2024, supplier quality report (ACAR Turkey) Dec 2024 (Giulia Romano, Alessandra Ferri)
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Documented information
Documented procedures/forms updated Dec 2024 (Luca Conti, Natascia Ghilardi)
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Operational planning and control
Plan order AG2312001, order #24000122 dated 02/12/2024 (Marco Bianchi, Chiara Villa)
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Determination of requirements for products and services
Customer order #54112, requirements review Dec 2024 (Giulia Romano, Chiara Villa)
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Design and development of products and services
Design files for 2025 planners (Adobe Illustrator, Photoshop), project records Nov–Dec 2024 (Chiara Villa, Marco Bianchi)
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Control of externally provided processes, products and services
Outsource evaluation: ACAR Turkey report Dec 2024; Bureau Veritas report #10422531224 (Alessandra Ferri)
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Production and service provision
Order #24000122 from supplier #72118 for 2025 diaries, production batch record Nov 2024, shipping B/L 2411002EX, 07/12/2024 (Marco Bianchi, Serena Rinaldi, Chiara Villa)
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Release of products and services
Inspection report Bureau Veritas #10422531224, 07/12/2024; product specs met (Marco Bianchi, Chiara Villa)
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Control of nonconforming outputs
NC: Defect in “HOT&Cold Avougato” design Dec 2024, authorized for factory outlet sale (Marco Bianchi, Matteo Greco)
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Monitoring, measurement, analysis and evaluation
KPI dashboard Oct–Dec 2024; customer satisfaction survey Dec 2024; loyalty program data (Giulia Romano, Paolo Ricci, Matteo Greco)
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Internal audit
IA program and report Jan 2025: sampled purchasing, logistics, design, warehouse, maintenance (Natascia Ghilardi, Alessandra Ferri, Chiara Villa, Serena Rinaldi, Matteo Greco)
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Management review
MR minutes Jan 2025 (last: 18/01/2025); next planned for 24/02/2025 (Nicola Lazzari, Natascia Ghilardi, Federica Moretti, Chiara Villa, Serena Rinaldi)
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General improvement
Infrastructure upgrade records Nov 2024; warehouse renovation; design innovation initiative Dec 2024 (Luca Conti, Paolo Ricci, Chiara Villa, Serena Rinaldi)
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Nonconformity and corrective action
No corrective actions open at audit; process verified in IA Jan 2025 (Natascia Ghilardi, Serena Rinaldi)
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Continual improvement
Improvement log, policy, objectives, IA Jan 2025, MR Jan 2025 (all departments)
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Not used yet
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