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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, Redesign and Development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
      • Templates
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity
    • GP-025 Corporate Governance
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
  • Records
  • TF_Legit.Health_Plus
  • Licenses and accreditations
  • External documentation
  • Procedures
  • Records
  • Procedures
  • GP-020 QMS Data analysis

GP-020 QMS Data analysis

Procedure flowchart​

Purpose​

This document sets out all the procedures used to determine, collect and analyze appropriate data to demonstrate the suitability, adequacy and effectiveness of the quality management system (QMS).

Scope​

All the information collected by performing the activities described within the QMS that contains data capable of being evaluated.

Responsibilities​

JD-001​

  • To lead and provide the necessary resources to properly perfom the required data analysis.
  • To analyse the findings, together with the rest of the team required, to determine the appearance of incidents.

JD-004​

  • To manage the QMS to guarantee the accomplishment of objectives and requirements.
  • To ensure that the records required for the data analysis are properly completed.
  • To ensure the data analysis is performed according to this procedure.

JD-005​

To perform the required data analysis according to this procedure to ensure the compliance with the QMS and the regulatory requirements.

All team members​

To notify the JD-004 or the JD-005 any non-conformity, deviation, need or abnormality detected during their daily job performance.

Development​

Inputs​

  • The T-002-002 Quality objectives and the T-002-003 quality indicators follow up.
  • The incident notifications received as it is specified at the procedure GP-004 Vigilance system.
  • Customer feedback, analyzed following the procedure GP-014 Feedback and complaints.
  • All the received non-conformities according to the procedure GP-006 Non-conformity. Corrective and preventive actions.
  • Purchases and suppliers information compiled according to the procedure GP-010 Purchases and suppliers evaluation.
  • Data from the Post-Market Surveillance (PMS) and/or the Post-Market Clinical Follow-up (PMCF) activities.
  • Information provided by internal and external audits.

Outputs​

  • T-020-001 Trend report

Data analysis procedure​

  • The T-002-002 Quality objectives and the T-002-003 quality indicators are established by the top management at the annual management review and reviewed quarterly according to the procedure GP-002 Quality planning and registered in the records themself.
  • The quality indicators are documented with the expected values. Each revision provides real information that will be compared with these expected values for the yearly period being reviewed. Additionally, a monitoring over the years is also performed to study additional trends that could affect the QMS performance.
  • In each annual management review, the JD-004 exposes the results, comparing them with previous results and in relation to the indicators of the T-002-003 quality indicators record.
  • All the abnormal findings will be thoroughly analysed and, under suspicion of incident, we will determine the causes and the immediate consequences. If there is an incident, we will communicated it in accordance with the GP-004 Vigilance system procedure.
  • Customer feedback is compiled and analyzed according to procedure GP-014 Feedback and complaints.
  • All the non-conformities are documented and followed up by the JD-004 through following the GP-006 Non-conformities. Corrective and preventive actions procedure. They are also reviewed during the annual management review, not only by themselves during the period reviewed, but also in comparison with previous years, to discover any possible trend that could affect the QMS performance and to establish actions to improve it.
  • The suppliers are evaluated not only at their selection period, but also yearly to ensure they still meet our requirements, following the procedure GP-010 Purchases and suppliers evaluation.
  • All the available data will be analysed by the JD-004and JD-005. Statistical and comparison techniques with previous exercises are used, appearing this way trends and/or incidents.
  • Each new trend that exceeds in a 25% the historic or foreseeable information will be registered as a T-006-001 Non-conformity report when required or a T-020-001 Trend report with the following minimum information:
    • Finding and its historic information.
    • Comparison with historic and/or foreseeable data. Investigation of the causes.
    • Defined actions.
    • Follow-up actions.
    • Responsibilities.
  • The JD-004 and JD-005 evaluate the trend reports that are presented in the annual management review, to evaluate this information and plan new actions.
  • All the data analysis will be compared with the risk management data for the product, comparing the risks and evaluating the control state of the finding.
  • All the clinical or non-clinical data that is also collected by the PMS and PMCF will be reported by the JD-005 that, together with the JD-001 (when they considers necessary their help or opinion), will update the clinical evaluation or the risk analysis in relation to the nature of the data.
  • All the new data will be compared with the previous data (clinical data), evaluating the contribution of new information according to the procedure GP-015 Clinical evaluation.
  • Regarding the risk management, the T-013-002 Risk management records will be updated when new risks appear or these have changed, in accordance with the Procedure GP-013 Risk management.
  • All the information related to the internal and external audits will be analysed by the JD-004 and the top management after each audit and at every annual management review. This data will be evaluated in relation to the last editions and the expected results.

Outputs​

  • New quality objectives and indicators will be documented and planned according to the procedure GP-002 Quality planning.
  • All the non-conformities will be treated according to the procedure GP-006 Non-conformity. Corrective and preventive actions.
  • Each incident notification will be treated as it is defined in the procedure GP-004 Vigilance system.
  • Suppliers evaluation are recorded at the T-010-001 Suppliers evaluation record.
  • All the new clinical or non-clinical data will be included in the T-007-003 PSUR and T-015-003 Clinical evaluation report.
  • Each new trend that exceeds in a 25% the historic or foreseeable information will be registered at the corresponding T-020-001 Trend report.
  • If an incident is detected it will be used:
    • Manufacturer Incident Report (MIR), using the format provided by the Guidance MEDDEV 2.12-1 rev.8 Vigilance system, Annex III: Report form from the manufacturer to the national competent authority.
    • Trend report (if it is an abnormal trend), provided by the Guidance MEDDEV 2.12-1 rev.8 Vigilance system, Annex VII: Manufacturer's trend report form.
    • Field Safety Corrective Action (FSCA), using the template provided by the Guidance MEDDEV 2.12-1 rev.8 Vigilance system, Annex IV: Report form for Field Safety Corrective Action.
    • Field Safety Notice (FSN), using the format provided by the Guidance MEDDEV 2.12-1 rev.8 Vigilance system, Annex V: Template for a Field Safety Notice.
  • If required, it will be modified:
    • Risk analysis & management.
    • Clinical evaluation.
    • All the information, directly or indirectly, will be analysed at the Management review report (T-002-003).

The data collected from the different records generated from the QMS procedures will be presented and discussed with the top management and compiled at the corresponding T-002-004 Annual management review report.

Associated documents​

  • GP-002 Quality planning
  • GP-004 Vigilance system
  • GP-006 Non-conformity. Corrective and preventive actions
  • GP-013 Risk management
  • GP-014 Feedback and complaints
  • GP-015 Clinical evaluation
  • T-002-002 Quality objectives
  • T-002-003 quality indicators
  • T-002-004 Annual management review report
  • T-006-001 Non-conformity report
  • T-007-003 PSUR
  • T-013-002 Risk management records
  • T-015-003 Clinical evaluation report
  • T-020-001 Trend report

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003, JD-004
  • Approver: JD-001
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Templates
  • Procedure flowchart
  • Purpose
  • Scope
  • Responsibilities
    • JD-001
    • JD-004
    • JD-005
    • All team members
  • Development
    • Inputs
    • Outputs
    • Data analysis procedure
    • Outputs
  • Associated documents
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)