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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
3 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 6.1.1b (Desireable
ISO 9001:2015 Effects)
17

18 Description
When planning for the quality management system, the organization shall consider
19
the issues referred to in 4.1 and the requirements referred to in 4.2 and determine
2 the risks and opportunities that need to be addressed to enhance desirable effects.

20

21

Product Specification Clause

22

3 Description
4

6
Objective Evidence
Risk Assessment Register Form PTI-FM-QA009 Dated 01st January 2018

As verified following is missing:

8 •Competitive (issues are identified, however, not addressed in the risk register)

•Market (issues are identified, however, not addressed in the risk register)

9
•Owner (identified as an interested party with identified requirements but not
addressed in the risk register)

The facility does not addresses opportunities in risk register Reference # Form PTI-
FM-QA009 Dated 01st January 2018. The statement used are risk and related
Files
opportunities are not identified:

•Serial # 10 Legal Requirements – Non-compliance requirements may affect in the

legal process delay

•Serial # 12 Information Technology – Loss of electronic data due to power failure

and any system related issues and damage of electronic data due to bugs.

•Serial # 13 Resource management – Identified supplier may fail to deliver right

resources on time.


Nonconformance/Concern Description
Risks identified as requirements of interested parties are not addressed in the Risk
Register which is declared as the actions to address risk and opportunities. There is
no process as observed which may address opportunities.

Determination of risks and opportunities taking into consideration context of the

organization (4.1) and needs and expectations of interested parties (4.2) is not
evident.

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 internal and external issues relevant to PTI’s QMS 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 internal / external issues
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
internal and external issues relevant to PTI’s QMS, in addition to the risks of product
quality and delivery. All the identified risks and opportunities related to internal and
external issues relevant to PTI’s QMS 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.

Supporting Documentation

No files found.

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