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DASHBOARD CERTIFICATION FACILITY DETAILS APPLICATIONS AUDITS

Facility ID: 17214

Audit ID: 82899

Initial 1st Surveillance - Primetech International Co.

Audit Dashboard
Finding Details
Findings

Finding Number Finding Status Review Decision Facility ID

1
2 Resolved Resolved 17214
10

11 Auditor Audit Type Finding Type Product/Service

UA Initial 1st Surveillance Minor Impact
12 Nonconformance No Impact
13

14

15

Requirement - MS Clause
16 Standard 4.2b
ISO 9001:2015
17

18 Description
The organization shall determine the requirements of these interested parties that
19
are relevant to the quality management system.
2

20

21 Product Specification Clause

22

Description
3

Objective Evidence
6 As per the Minutes of the Meeting Dated 07th May 2020 multiple issues are
identified against the interested parties. In relation with the following aspects
7 identified like Technology and competitive, the List of interested parties shows no
information with respect to the Technology owners and competitors needs and
8 expectation requirements.

9
Reference List of Interested Parties Dated 07th May 2020

Nonconformance/Concern Description
Files
Needs and expectations of interested parties are not determined by the organization.

Response

 Raneesh AK -  [13-Sep-2020]  [ Correction ]

A meeting was conducted on 29/07/2020 to verify the risk and opportunities identified
based on the needs and expectations of interested parties and the same were now
recorded as a part of the meeting minutes and a separate risk assessment register
made with the control features of the identified risks.

 Raneesh AK -  [13-Sep-2020]  [ Root Cause Analysis ]

As per API Q1 requirement, the risk assessment and mitigation and contingency
planning with regard to product quality and delivery were required and hence these are
so far considered as input for risk assessment. During the meeting dated on
07/05/2020 determination of risks and opportunities related to needs and expectations
of interested parties were considered, however the specific mention of the considered
risks was not recorded in the risk assessment register due to misinterpretation of
requirements by the Quality Manager.

 Raneesh AK -  [13-Sep-2020]  [ Corrective Action(s) ]

Procedure for risk assessment, mitigation and contingency planning PTI-PR-QA03 is

revised on 28/07/2020 to consider and record the risks and opportunities related to
needs and expectations of interested parties in addition to the risks of product quality
and delivery. All the identified risks and opportunities related to interested parties and
their requirements shall be recorded in a separate risk assessment register.

General Manager imparted training to risk control committee members and department
heads on the revised control features of PTI-PR-QA03, requirements of ISO 9001:2015
clause 4.1, 4.2 & 6.1.1 and on the importance of recording risks and opportunities to
ensure proper executing actions in the future.

Effectiveness of this training verified by seeking answers from the trainees on the
trained topic during the training and verified by the review of risk assessment register
after the training and found that the training is effective.

 David Elliot -  [5-Oct-2020]  [ API Response ]

The effectiveness of your corrective action will be evaluated at your next API audit.

Supporting Documentation

File Name Description File Link Type Created Created

Name Date By

Raneesh
AAR-2-1+3-1.pdf AAR-2-1+3-1.pdf General 9/13/2020
Ak

PTI-PR-QA03-Rev- PTI-PR-QA03-Rev- Raneesh

General 9/13/2020
02.pdf 02.pdf Ak

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