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Company A supplies pharmaceuticals to the MOI - Who is responsible?

#1
case study
1-ministry of interior affairs has an agreement with ABC pharmaceutical company to supply the MOI with pharmaceutical products the MOI delivers the packaging material to ABC company when the products were received by MOI a large percentage was found defective due to the interaction between packaging materials and products
A) who is responsible
B) what ISO clause that gouverns this issue
2-
A)Fill the non conformity report:
In purchasing department the auditor asks how the new supplier for TMXI 01 items was selected the purchasing clerk explains the regular supplier couldn’t meet the delivery date and the order was placed with a supplier that they had never used before only because the price quoted was extremely low the clerk states that no other evaluation was carried
A) if you don’t think there is no sufficient evidence for non conformity state the reasons for your decision and state also what further action the auditor should take
 

Al Rosen

Staff member
Super Moderator
#2
case study
1-ministry of interior affairs has an agreement with ABC pharmaceutical company to supply the MOI with pharmaceutical products the MOI delivers the packaging material to ABC company when the products were received by MOI a large percentage was found defective due to the interaction between packaging materials and products
A) who is responsible
B) what ISO clause that gouverns this issue
2-
A)Fill the non conformity report:
In purchasing department the auditor asks how the new supplier for TMXI 01 items was selected the purchasing clerk explains the regular supplier couldn’t meet the delivery date and the order was placed with a supplier that they had never used before only because the price quoted was extremely low the clerk states that no other evaluation was carried
A) if you don’t think there is no sufficient evidence for non conformity state the reasons for your decision and state also what further action the auditor should take
What test is this from?
 

Al Rosen

Staff member
Super Moderator
#3
case study
1-ministry of interior affairs has an agreement with ABC pharmaceutical company to supply the MOI with pharmaceutical products the MOI delivers the packaging material to ABC company when the products were received by MOI a large percentage was found defective due to the interaction between packaging materials and products
A) who is responsible
B) what ISO clause that gouverns this issue
2-
A)Fill the non conformity report:
In purchasing department the auditor asks how the new supplier for TMXI 01 items was selected the purchasing clerk explains the regular supplier couldn’t meet the delivery date and the order was placed with a supplier that they had never used before only because the price quoted was extremely low the clerk states that no other evaluation was carried
A) if you don’t think there is no sufficient evidence for non conformity state the reasons for your decision and state also what further action the auditor should take
1A- ABC pharmaceutical is responsible.
1B-
8.4.1 General
The organization shall ensure that externally provided processes, products and services conform to
requirements.
The organization shall determine the controls to be applied to externally provided processes, products
and services when:
a) products and services from external providers are intended for incorporation into the organization’s
own products and services;
b) products and services are provided directly to the customer(s) by external providers on behalf of
the organization;
c) a process, or part of a process, is provided by an external provider as a result of a decision by the
organization.

The organization shall determine and apply criteria for the evaluation, selection, monitoring of
performance, and re-evaluation of external providers, based on their ability to provide processes or
products and services in accordance with requirements. The organization shall retain documented
information of these activities and any necessary actions arising from the evaluations.


2- The organization failed to determine the controls to be applied to externally provided products. and failed to determine and apply criteria for evaluation, selection, monitoring ...... etc.

You can fill in the evidence from the question.
 
#4
1A- ABC pharmaceutical is responsible.
1B-
8.4.1 General
The organization shall ensure that externally provided processes, products and services conform to
requirements.
The organization shall determine the controls to be applied to externally provided processes, products
and services when:
a) products and services from external providers are intended for incorporation into the organization’s
own products and services;
b) products and services are provided directly to the customer(s) by external providers on behalf of
the organization;
c) a process, or part of a process, is provided by an external provider as a result of a decision by the
organization.

The organization shall determine and apply criteria for the evaluation, selection, monitoring of
performance, and re-evaluation of external providers, based on their ability to provide processes or
products and services in accordance with requirements. The organization shall retain documented
information of these activities and any necessary actions arising from the evaluations.


2- The organization failed to determine the controls to be applied to externally provided products. and failed to determine and apply criteria for evaluation, selection, monitoring ...... etc.

You can fill in the evidence from the question.
what action should auditer take in this case and why?
 
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