Case study help as per ISO 9001: 2015

MDGMG

Posts Moderated
#1
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-conformoity :
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.
 
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John Broomfield

Staff member
Super Moderator
#2
Is the Design Manager new?

At least 2 years has passed since this equipment was designed. So, the latest drawing may not be the pertinent drawing.

Examine the superseded drawings (or maintenance manual) of the modified safety mechanism used for contract A123.

Potentially, this is a nonconformity:

Nature: "Failure to ensure design outputs (drawings) are adequate for subsequent processing (maintenance) ".
See: ISO 9001:2015, clause 8.3.5b.
Evidence: Safety mechanism not included in approved drawings (include dwg number and rev) for the equipment (serial number X134, rev 3) as applicable to contract A123.

Ask what are the criteria for including the customer in risk assessments? Do these criteria change for safety devices?
 

Randy

Super Moderator
#3
..........or the previous review and testing found nothing and it required multiple cycles and use for the flaw to reveal itself after end user operation. It can happen, therefore technically there were no errors then, but improvement needs to take place now in the testing or review process as well as in the design.....Multiple pathways & possible causes.... Reminds me of a Jimmy Stewart movie "No Highway in the Sky" or maybe United 232 as examples, even the Shuttle program.
 

Tagin

Trusted Information Resource
#4
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.
If the change to the safety mechanism was not in the drawings, then what instructed manufacturing to install the change to the safety mechanism prior to delivery and installation of the equipment?
 

Pjservan

Involved In Discussions
#5
Looks like how the change was made needs to be reviewed as you stated "drawings do not contain a modification to the safety mechanism that was made prior to delivery and installation of the equipment." The question to me is how this modification was made? Was it consider a Design Change? How was risk associated with the change assessed and how was it determined that it was a minor change. Was the situation that the customer (with the complaint) considered? What is being done about it now?
 

MDGMG

Posts Moderated
#6
Looks like how the change was made needs to be reviewed as you stated "drawings do not contain a modification to the safety mechanism that was made prior to delivery and installation of the equipment." The question to me is how this modification was made? Was it consider a Design Change? How was risk associated with the change assessed and how was it determined that it was a minor change. Was the situation that the customer (with the complaint) considered? What is being done about it now?

There is a design changed but it was considered as minor and same was not included in drawing.
 

MDGMG

Posts Moderated
#7
If the change to the safety mechanism was not in the drawings, then what instructed manufacturing to install the change to the safety mechanism prior to delivery and installation of the equipment?
1) Machine was supplied with previous design (which not included with safety mechanism)
2) During the visit by the service official, He was having only new design
 

Tagin

Trusted Information Resource
#8
1) Machine was supplied with previous design (which not included with safety mechanism)
2) During the visit by the service official, He was having only new design
Ok, I misunderstood your original post. The machine was not originally supplied with the safety change.

The drawings do not contain a modification to the safety mechanism that was made prior to delivery and installation of the equipment.
Then it does not appear that any design change has ever been approved or implemented. What evidence do you have that a design change was actually approved and implemented?
 

Jim Wynne

Staff member
Admin
#9
You seem to be contradicting yourself. You first stated that the modification was made to the installed equipment:
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.
Now you say that it wasn't.
1) Machine was supplied with previous design (which not included with safety mechanism)
Which is correct?
 

MDGMG

Posts Moderated
#10
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.
 
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