Case study help as per ISO 9001: 2015

John Broomfield

Leader
Super Moderator
Lack of document control doesn’t touch the bigger problems:

1. Sloppy risk based thinking when designing a safety device
2. Design information failing to enable maintenance of said device

But, maybe, just maybe the auditee’s corrective action team will find and act on these system failings.
 

Tagin

Trusted Information Resource
2) The drawing do not contain a modification to the safety mechanism that was made prior to delivery and installation of the equipment

What is the evidence that "a modification to the safety mechanism" was made by the company? If it doesn't show up in the latest drawings, then where are you getting the information that a change was actually made? Is there an ECO or similar doc?
 

MDGMG

Posts Moderated
Than y
Lack of document control doesn’t touch the bigger problems:

1. Sloppy risk based thinking when designing a safety device
2. Design information failing to enable maintenance of said device

But, maybe, just maybe the auditee’s corrective action team will find and act on these system failings.
ou
Lack of document control doesn’t touch the bigger problems:

1. Sloppy risk based thinking when designing a safety device
2. Design information failing to enable maintenance of said device

But, maybe, just maybe the auditee’s corrective action team will find and act on these system failings.



Thank you
 

Jim Wynne

Leader
Admin
There are three aspects to the case study given (needs considerable understanding)
1) Equipment was designed , manufactured and supplied two years earlier with contract number A123
2) The drawing do not contain a modification to the safety mechanism that was made prior to delivery and installation of the equipment
3) Design manager replies that the change was reviewed and considered to be minor on the equipment with no impact on the equipment and it didn't affect the customers contract specification.

Hope above points will help for conclusion. For my point of view further investigation is required as there is a lack of document control and review mechanism.
I don't know if you were replying to me, but if you were, you didn't answer my question.
 

Abraham

Registered
Please guide us for following case study:

You are auditing the design and development process in an organisation that designs and manufactures industrial equipment.
They are currently dealing with a serious customer complaint relating to faulty safety mechanisms. They have sent engineers to this customer to repair some equipment they designed, manufactured and supplied two years earlier for contract number A123.
You find a recent note on file that states that the engineers are currently having difficulty in repairing the equipment. They have been issued with the latest drawings for the equipment (serial number X134, revision 3). The drawings do not contain a modification to the safety mechanism that was made prior to delivery and installation of the equipment.
You confirm with the Design Manager that revision 3 is the current version of the drawings and that revision 3 does not include the change to the safety mechanism. You ask the Design Manager why the modification to safety mechanism was not made to the drawing and he replies that the change was reviewed and considered to be minor with no impact on the equipment and it didn’t affect the customer’s contract specification.

Question: A) If it's non-non-conformity :
1) Description of non conformity
2) Relevant evidence
3) ISO 9001:2015 clause and requirement
B) If it's not a non-conformity,
1) Evidence for reporting non-conformity
2) Audit trails you would follow, including, evidence sought and purpose.


IRCA QMS AUDIT – NONCONFORMITY REPORT
Description of the nonconformity

The organization has identified that it has failed to meet the customer requirements for safety mechanism in the latest drawings issued for the equipment (serial number X134, revision 3). The drawings do not contain a modification to the safety mechanism that was made prior to delivery and installation of the equipment.
Relevant evidence
The drawings do not contain a modification to the safety mechanism that was made prior to delivery and installation of the equipment.
It is confirmed with the Design Manager that the revision 3 is the current version of the drawings and that revision 3 does not include the change to the safety mechanism. Further when Design Manager was asked why the modification to safety mechanism was not made to the drawing . He replied that the change was reviewed and considered to be minor with no impact on the equipment and it didn’t affect the customer’s contract specification.
ISO 9001: 2015 clause and requirement
7.5.3.2 For the control of documented information, the organization SHALL address the following activities, as applicable:
c)control of changes (e.g. version control);
 

Luciene

Registered
Please guide us for following case study:

You are auditing the design and development process in an organisation that designs and manufactures industrial equipment.
They are currently dealing with a serious customer complaint relating to faulty safety mechanisms. They have sent engineers to this customer to repair some equipment they designed, manufactured and supplied two years earlier for contract number A123.
You find a recent note on file that states that the engineers are currently having difficulty in repairing the equipment. They have been issued with the latest drawings for the equipment (serial number X134, revision 3). The drawings do not contain a modification to the safety mechanism that was made prior to delivery and installation of the equipment.
You confirm with the Design Manager that revision 3 is the current version of the drawings and that revision 3 does not include the change to the safety mechanism. You ask the Design Manager why the modification to safety mechanism was not made to the drawing and he replies that the change was reviewed and considered to be minor with no impact on the equipment and it didn’t affect the customer’s contract specification.

Question: A) If it's non-non-conformity :
1) Description of non conformity
2) Relevant evidence
3) ISO 9001:2015 clause and requirement
B) If it's not a non-conformity,
1) Evidence for reporting non-conformity
2) Audit trails you would follow, including, evidence sought and purpose.


IRCA QMS AUDIT – NONCONFORMITY REPORT
Description of the nonconformity

The organization has identified that it has failed to meet the customer requirements for safety mechanism in the latest drawings issued for the equipment (serial number X134, revision 3). The drawings do not contain a modification to the safety mechanism that was made prior to delivery and installation of the equipment.
Relevant evidence
The drawings do not contain a modification to the safety mechanism that was made prior to delivery and installation of the equipment.
It is confirmed with the Design Manager that the revision 3 is the current version of the drawings and that revision 3 does not include the change to the safety mechanism. Further when Design Manager was asked why the modification to safety mechanism was not made to the drawing . He replied that the change was reviewed and considered to be minor with no impact on the equipment and it didn’t affect the customer’s contract specification.
ISO 9001: 2015 clause and requirement
7.5.3.2 For the control of documented information, the organization SHALL address the following activities, as applicable:
c)control of changes (e.g. version control);
Hi Abraham,

Is that the resolution of the study case?
 
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