Sample QMS Internal Report

Sample QMS Internal Report

Audit Report No: QMS-INT-001-2060

Audit Date: May 12, 2060

Auditor(s):

  • John M. Daniels (Lead Auditor)

  • Sarah L. Evans (Co-Auditor)

Department/Process Audited: Manufacturing Process – Quality Control Department

Audit Location: FutureTech Manufacturing Plant, Sector 5, Green City Industrial Zone

Audit Objective: To ensure compliance with ISO 9001:2060 standards, assess the effectiveness of quality control processes, and identify areas for continuous improvement.

Audit Scope:

The audit covered all aspects of the Quality Control department, including process documentation, training records, equipment calibration, non-conformance management, and internal communication processes.

Audit Criteria:

  • ISO 9001:2060 Requirements

  • FutureTech QMS Manual (Version 3.0)

  • Internal Standard Operating Procedures (SOPs) for quality inspection and testing

Audit Findings:

  1. Positive Observations:

    • Equipment Calibration Compliance: All inspection equipment was calibrated following the calibration schedule, with no overdue equipment. Calibration records were up-to-date as per the audit logs (Calibrated Tools No.: CT-2060-0002, CT-2060-0035).

    • Employee Training: Quality control staff received all required training, with a 100% completion rate recorded in the Training Management System (Employee IDs: E2060-145, E2060-189). The training covered new testing methods introduced in March 2060, improving defect detection by 15%.

    • Improved Inspection Process: A new automated inspection system, introduced in January 2060, has reduced inspection time by 30%, increasing overall production efficiency.

  2. Non-conformities:

    • Document Control Issue: The Control of Records Procedure (Document No. QMS-PRO-002-2060) was not followed correctly. Several test results from April 2060 were missing sign-off approvals from department heads (Non-Conformance Report No. NCR-2060-008).

    • Non-conformance Handling: A backlog of corrective actions related to product defects from February 2060 (Issue ID: NC2060-012) remains unresolved. Corrective action timelines need to be adhered to as per the company’s QMS guidelines.

Root Cause Analysis:

For the non-conformities identified:

  • Document Control Issue: The missing approvals were due to an oversight during the transition to a new digital signature system in early April 2060.

  • Non-conformance Handling: Lack of proper follow-up on corrective actions resulted from resource allocation issues, with staff focusing on urgent production demands rather than addressing older non-conformance reports.

Recommendations:

  1. Improve Document Control Adherence: Conduct refresher training for department heads on the new digital approval system and ensure regular audits of digital signatures are performed weekly.

  2. Resolve Corrective Action Backlog: Allocate additional resources to address the backlog of non-conformances from February 2060. Prioritize issues that affect production quality and escalate unresolved actions to senior management.

  3. Enhance Communication Channels: Establish a bi-weekly meeting between the Quality Control and Production departments to streamline issue resolution, ensuring that corrective actions are tracked more effectively.

Audit Conclusion:

The audit confirmed that while the Quality Control department is largely compliant with ISO 9001:2060 standards, specific areas of improvement, such as document control and non-conformance handling, need immediate attention. Management must take proactive steps to resolve open non-conformities and maintain adherence to internal procedures.

Follow-up Actions:

  1. Responsible Person(s):

    • Document Control Review: Sarah L. Evans

    • Non-conformance Action Resolution: John M. Daniels

  2. Deadline for Completion:
    June 30, 2060

  3. Next Audit Date:
    November 5, 2060

Approval:

  1. Lead Auditor:


    [Your Name]

  2. Reviewed By (Quality Manager):

    Linda K. Harrison

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