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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

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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.