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    NCRs - Quality

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    Sharaf Ageed
    This document lists 25 nonconformities (NCRs) found during an internal or external audit of an organization's quality management system. Some key issues include a lack of defined responsibilities for quality management, incomplete corrective actions from previous audits, non-compliance with maintenance and inspection plans, and missing validation and monitoring processes. Overall the audit found gaps in implementing and ensuring the effectiveness of the quality system per the requirements of ISO 9001.

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    NCRs - Quality

    Uploaded by

    Sharaf Ageed
    255 views8 pages
    This document lists 25 nonconformities (NCRs) found during an internal or external audit of an organization's quality management system. Some key issues include a lack of defined responsibilities for quality management, incomplete corrective actions from previous audits, non-compliance with maintenance and inspection plans, and missing validation and monitoring processes. Overall the audit found gaps in implementing and ensuring the effectiveness of the quality system per the requirements of ISO 9001.

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    This document lists 25 nonconformities (NCRs) found during an internal or external audit of an organization's quality management system. Some key issues include a lack of defined responsibilities for quality management, incomplete corrective actions from previous audits, non-compliance with maintenance and inspection plans, and missing validation and monitoring processes. Overall the audit found gaps in implementing and ensuring the effectiveness of the quality system per the requirements of ISO 9001.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    255 views8 pages

    NCRs - Quality

    Uploaded by

    Sharaf Ageed
    This document lists 25 nonconformities (NCRs) found during an internal or external audit of an organization's quality management system. Some key issues include a lack of defined responsibilities for quality management, incomplete corrective actions from previous audits, non-compliance with maintenance and inspection plans, and missing validation and monitoring processes. Overall the audit found gaps in implementing and ensuring the effectiveness of the quality system per the requirements of ISO 9001.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    of 8

    NCRs

    No Statement Clause(s)

    1 (Control of measuring and monitoring devices)


    excluded in the scope of quality management
    7.6 /
    system as stated in the quality manual but no clear
    4.2.2
    justification mentioned and it implemented in real
    work
    2 Responsibilities and authorities towards the quality 5.5.1
    management system are not defined on the job
    description of all functions at all levels
    3 There are 8 NCRs raised form last internal audit
    and correction done in a good manner however the
    8.2.2/
    corrective actions and evaluation of effectiveness 8.5.2
    need to be conducted
    No Statement Clause(s)

    4 The output of management review meeting not


    converted to corrective actions as per required by 5.6.3
    management review procedure QP-011
    5 The maintenance program for JAN & FEB 2013 not
    conducted as per required by 2013 maintenance
    6.3 / 7.5.1.c
    plan.
    6 User satisfaction survey found available for ten
    8.4
    users, but there was no analysis of these data.
    7 Preventive maintenance for X-ray equipment not
    6.3/7.5.1.c/
    conducted as per planned due to lack of spare
    7.6
    parts.
    8 In the material stores auditor noticed that there were no
    tags or stickers to show the inspection status of the
    7.5.3/7.5.
    materials.
    No Statement Clause(s)

    9 Actions to eliminate the causes of potential


    nonconformities in order to prevent their 8.5.3
    occurrence not found satisfactory
    10 The scope of quality manual need to be clear and 4.2.2.b
    brief.
    11 Use of statistical techniques need to be more
    advance. 8.1
    12 Recommendation for management review input
    need to be conducted from a number of sources. 5.6.2
    13 Translation of some directions in the quality policy
    in to SMART objectives not fully conducts. 5.4.1
    No Statement Clause(s)

    14 Some used records and W/I are not fully identified


    and controlled 4.2.3
    15 Statutory and regulatory requirements applicable to
    the service are not fully identified in form CTAF-01- 5.1.a,
    04. 7.2.1c
    16 Customer complaints and their recommendations
    7.2.3.c
    need to be conducted with cooperation of other
    parties in the airport or to find creative way.
    17 In the Food Analysis Laboratory two operators 6.4/6.2.2.d
    were not wearing nylon caps
    No Statement Clause(s)

    18 In the Quality Manager’s office auditor reviewed a


    number of internal audit reports. Auditor noted that 8.2.2
    regularly in all audit rounds for past two years
    some 70% of nonconformances were noted in the
    design department. The procedures required
    auditing all departments at six monthly intervals
    and this was followed strictly ever since
    implementation of the system.
    19 There are no suitable methods to demonstrate the 8.2.3
    ability of the processes to achieve planned results.
    20 In the production hall auditor noticed two weighing
    7.6
    machines. Weighing machine serial no. 1624 had
    an affixed label stating due date for calibration
    which was over 4 months ago. Weighing machine
    serial no. 1636 had no calibration label attached.
    No Statement Clause(s)

    21 There is no specific action for monitoring customer


    perception. 8.2.1

    22 Before an audit in the Design Department in XYZ


    7.3.6
    Ltd. the auditor reviewed the Design and
    Development Manual and noticed that it did not
    contain procedures for design validation. During
    the audit the auditor reviewed the documentation
    pertinent to a selection of ten completed projects #
    99/007, 99/010, 99/020, 99/025, 99/031, 99/042,
    99/051, 99/054, 99/062 and 99/070 and was
    unable to find any records of design validation
    activity. Design Director explained that as every
    design was unique and one off the requirement for
    design validation was not applicable to the
    products they were designing. 7.3.6
    No Statement Clause(s)

    23 There are no clear actions to ensure the


    effectiveness of the quality management system 8.5.1
    through the use of the quality policy, quality
    objectives, audit results, analysis of data,
    corrective and preventive actions and management
    review.
    24 QC Records not indicate the person(s) authorizing
    8.2.4
    release of product for delivery to the customer.
    25 Manual handling used due to lack of handling 7.5.5/
    equipment 6.4/ 5.1.e

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