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Edit Audit Report (INITIAL) for LEGAMI S.R.L
Quotation:
GCB-2025-07-0009
Address:
Via Stezzano, 18, 24052 Azzano San Paolo (Bergamo), Italy Via Ozanam,2, 24126 (Bergamo) , Italy
Contact Person:
Natascia Ghilardi
Email:
natascia.ghilardi@legami.com
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
Team Leader Recommandations:
The company shows implementation of effective quality management system according to ISO 9001:2015
No. of Man-Days:
Auditors:
Auditor Name
Auditor Role
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Auditee Members:
Auditee Name
Position
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Audit Findings:
Delete
Clause No.
Requirements/Departement
Understanding the organization and its context
Evidence
Board meeting minutes Oct 2024, SWOT review Q4 2024 (Nicola Lazzari, Giulia Romano)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Understanding the organization and its context
Evidence
Board meeting minutes Oct 2024, SWOT review Q4 2024 (Nicola Lazzari, Giulia Romano)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Understanding needs and expectations of interested parties
Evidence
Stakeholder analysis Nov 2024, customer survey results Dec 2024 (Giulia Romano)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Determining the scope of the QMS
Evidence
QMS scope document (rev. Dec 2024), no exclusions (Natascia Ghilardi)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
QMS and its processes
Evidence
Process map, KPI report Oct–Dec 2024, monthly analysis (Marco Bianchi, Matteo Greco, Paolo Ricci)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Leadership and commitment
Evidence
Top management attendance in opening/closing & MR Jan 2025 (Nicola Lazzari, Natascia Ghilardi)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Quality policy
Evidence
Policy review Dec 2024, environmental commitment visible (Natascia Ghilardi)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Organizational roles, responsibilities, authorities
Evidence
Job descriptions updated Nov 2024 for key roles; sample: Junior Quality Specialist (Federica Moretti), Magazziniere Capo (Matteo Greco)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Actions to address risks and opportunities
Evidence
Risk assessment review Dec 2024, Board approval (Nicola Lazzari, Alessandra Ferri, Serena Rinaldi)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Quality objectives and planning to achieve them
Evidence
Objectives plan 2025, improvement in logistics process (lead time Oct–Dec 2024) (Paolo Ricci, Serena Rinaldi)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Planning of changes
Evidence
Change management register, change review meeting Jan 2025 (Natascia Ghilardi, Marco Bianchi, Chiara Villa)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Resources
Evidence
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.
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Competence
Evidence
Training records: Excel training 10/10/2024, 24/11/2024; Job descriptions reviewed Jan 2025 (Federica Moretti, Chiara Villa, Serena Rinaldi)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Awareness
Evidence
Employee interviews and awareness checks Dec 2024 (all departments: incl. warehouse, design, maintenance)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Communication
Evidence
Product catalog Nov 2024, supplier quality report (ACAR Turkey) Dec 2024 (Giulia Romano, Alessandra Ferri)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Documented information
Evidence
Documented procedures/forms updated Dec 2024 (Luca Conti, Natascia Ghilardi)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Operational planning and control
Evidence
Plan order AG2312001, order #24000122 dated 02/12/2024 (Marco Bianchi, Chiara Villa)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Determination of requirements for products and services
Evidence
Customer order #54112, requirements review Dec 2024 (Giulia Romano, Chiara Villa)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Design and development of products and services
Evidence
Design files for 2025 planners (Adobe Illustrator, Photoshop), project records Nov–Dec 2024 (Chiara Villa, Marco Bianchi)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Control of externally provided processes, products and services
Evidence
Outsource evaluation: ACAR Turkey report Dec 2024; Bureau Veritas report #10422531224 (Alessandra Ferri)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Production and service provision
Evidence
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)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Release of products and services
Evidence
Inspection report Bureau Veritas #10422531224, 07/12/2024; product specs met (Marco Bianchi, Chiara Villa)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Control of nonconforming outputs
Evidence
NC: Defect in “HOT&Cold Avougato” design Dec 2024, authorized for factory outlet sale (Marco Bianchi, Matteo Greco)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Monitoring, measurement, analysis and evaluation
Evidence
KPI dashboard Oct–Dec 2024; customer satisfaction survey Dec 2024; loyalty program data (Giulia Romano, Paolo Ricci, Matteo Greco)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Internal audit
Evidence
IA program and report Jan 2025: sampled purchasing, logistics, design, warehouse, maintenance (Natascia Ghilardi, Alessandra Ferri, Chiara Villa, Serena Rinaldi, Matteo Greco)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Management review
Evidence
MR minutes Jan 2025 (last: 18/01/2025); next planned for 24/02/2025 (Nicola Lazzari, Natascia Ghilardi, Federica Moretti, Chiara Villa, Serena Rinaldi)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
General improvement
Evidence
Infrastructure upgrade records Nov 2024; warehouse renovation; design innovation initiative Dec 2024 (Luca Conti, Paolo Ricci, Chiara Villa, Serena Rinaldi)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Nonconformity and corrective action
Evidence
No corrective actions open at audit; process verified in IA Jan 2025 (Natascia Ghilardi, Serena Rinaldi)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Continual improvement
Evidence
Improvement log, policy, objectives, IA Jan 2025, MR Jan 2025 (all departments)
Result
OK
NC
NA
Delete
Clause No.
Requirements/Departement
Evidence
Not used yet
Result
OK
NC
NA
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