1. Draft Audit Report Page 1 of 8
Draft Audit Report
Presented to
N S Automotive
On
August 10, 2015
By
Nisarg Shah Evaluation Agency
440 McMurchy Ave s,
Brampton, ON, L6Y 2N5
2. Draft Audit Report Page 2 of 8
Purpose:
To assess the effectiveness of Quality Management System of N S Automotive for
compliance with the requirements of ISO 9001:2008
Objective:
For the purpose of re-certification of ISO 9001:2008.
Scope:
All the departments were included in the audit and were audited on clauses of ISO
9001:2008
Auditee:
N S Automotive
61 Claireville Drive, Toronto,
ON, M9W 5Z7, Canada
(905)-123-4567
Client:
N S Automotive
61 Claireville Drive, Toronto,
ON, M9W 5Z7, Canada
(905)-123-4567
Auditor:
Nisarg Shah Evaluation Agency
440 McMurchy Ave s,
Brampton,
Canada, ON, L6Y 2N5
(647)-404-7150
Audit Date: 9th and 10th August, 2015
Audit Team:
1. Mr. Nisarg Shah – Audit Team Leader
2. Mr. Sanket Pandya – Audit Team Member
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FINDINGS:
Finding 1:
ISO 9001:2008 Clause: 8.3 Control of non-conforming product:
“The organization shall ensure that product which does not conform to product
requirements is identified and controlled to prevent its unintended use or delivery. A
documented procedure shall be established to define the controls and related
responsibilities and authorities for dealing with nonconforming product.”
Statement of finding: Control of non-conforming product not implemented as per
documented procedure according QSP 04
Observation 1: While auditing the control of non-conforming products on 10th Aug,
Between 10.30 to 11 in the morning, lead auditor found that there were 45 non-
conforming items in the quarantine area, out of these 6 items were not tagged by
a red tag.
Observation 2: The same date and time mentioned above, there were only 43
items in the NCR Log Form (QF 18), whereas physically there 45 items
Observation 3: On the same date and time, 3 non-conforming items in quarantine
area, there were no details found in Corrective Action Request Form (QF 10)
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Finding 2:
ISO 9001:2008 Clause: 7.6 Control of monitoring and measuring equipment
“Where necessary to ensure valid results, measuring equipment shall be calibrated or
verified, or both, at specified intervals, or prior to use, against measurement standards
traceable to international or national measurement standards; where no such standards
exist, the basis used for calibration or verification shall be recorded. In addition, the
organization shall assess and record the validity of the previous measuring results when
the equipment is found not to conform to requirements. The organization shall take
appropriate action on the equipment and any product affected.”
Statement of finding: Control of monitoring and measuring equipment not effective
Observation 1: When auditing the production shop floor on 9th August, between
2 to 3.30 pm, 2 of the measuring equipment, a digital vernier caliper (NSE17) and
a dial bore gauge (NSE21) found out of calibration and the instruments were still
used in production shop floor. Calibration was due for both the instruments on
20th July, 2015 i.e. 3 weeks ago.
Observation 2: The equipment ran out of calibration 3 weeks ago, and there is no
any action taken on the parts produced in these 3 weeks, or no any records
showing any action on the production taken was observed the same time.
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Finding 3
ISO 9001:2008 Clause: 7.4.1 Purchasing process
“The organization shall evaluate and select suppliers based on their ability to supply
product in accordance with the organization's requirements. Criteria for selection,
evaluation and re-evaluation shall be established. Records of the results of evaluations
and any necessary actions arising from the evaluation shall be maintained”
Statement of finding: Procedure for purchasing QSP 07 is not followed consistently
Observation 1: While observing the activities of purchase department on 10th
August, afternoon session, differing to the Quality Manual (Page 19) which states
that, “NS Automotive Ltd. evaluates and selects suppliers based on their ability
to supply product in accordance with the organization’s requirements.” One of the
raw material, High-Strength low alloy steel was purchased twice from “Sheet
metal works Ltd” which has not been evaluated by N S Automotive for their ability
to meet their requirement.
Observation 2: Also as mentioned in Quality Policy that the suppliers are re-
evaluated at least once in a year and the records are maintained in QF 07, while
observing the form, only five such records were found. After interviewing the
Purchase Manager, he confirmed that the re-evaluations are not conducted
regularly.
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Finding 4
ISO 9001:2008 Clause: 4.2.4 Control of Records
“The organization shall establish a documented procedure to define the controls needed
for the identification, storage, protection, retrieval, retention and disposition of records.
Records shall remain legible, readily identifiable and retrievable.”
Statement of finding: Control of records not followed consistently as per QSP 02
Observation 1: While auditing records on 10th August, 2015 between 9 to 10 am,
audit team member Mr. Pandya found that there were 2 forms (Customer
Material Log and Modification Approval) which were saved outside the folder
“Quality Forms” and were given folder name “QForms”, the records were not
readily identifiable and retrievable.
Observation 2: During the same time, Mr. Pandya also observed that QF02,
QF08, QF10 and QF13 were filled with pencil which contradicts from the QSP
02 which states all records should be either filled with pen or ink.
Observation 3: During audit of Production department during 9 to 10.30 pm on
9th August, audit team leader found that the purchase orders and information
are not retained for the retention period mentioned in QSP 02.
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Noteworthy Accomplishments:
5.5.1 Responsibility and authority
NS Automotive Ltd. has a semi-formal structure showing organization chart. All
employees are communicated of their responsibilities and authorities. All employees of N
S Automotive are well aware of their responsibilities and authority and have their authority
and responsibility matrix available in department.
6.2.2 Competence, training and awareness
NS Automotive Ltd. ensures that employees are competent to perform work affecting
conformity to product requirements. Where applicable, the provisions of training or other
actions are made to achieve the necessary competence. Personnel are aware of the
relevance and importance of their activities and how they contribute to the achievement
of the quality objectives.
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Corrective action request:
Corrective action request has been issued for the non-conformities and observations
described in this draft report. N S Automotive has agreed to respond to corrective action
request within 45 days from today’s date (10th August, 2015). Nisarg Shah Evaluation
Agency will revisit the facility of N S Automotive after 45 days to determine whether the
corrective actions have been implemented and effective. On satisfactory determination of
implementation and effectiveness of corrective actions implemented, Nisarg Shah
Evaluation Agency will consider the ISO 9001:2008 re-certification.
Lead Auditor: Nisarg Shah
Lead Auditor signature:__________________ Date: 10th August, 2015.