Case Studies

Sr. Applicable
Observations During Audit
No. Clause
Water pump bearings were observed in rusty condition in the
1
stores.
Raw material supplier is selected only on basis of the relationship
with the management. Procedure for selection demands
2
evaluation before selection and also described the criteria like
necessary equipment, personnel etc.
Customer feedback is not considered in management review
3
meeting held on 3rd February.
Customer satisfaction is not captured in the organization for last
4
one year after ISO certification. Frequency set is twice a year.
Purchase order for the month of January could not be produced in
5
almost 15 mins. During the audit in February in the same year
Internal audit is carried out on 2.6.2018. NCR was made on
6 3.6.2018. Action to eliminate non- conformity target date
committed is 1.12.2018.

7 Management review was not conducted as per defined frequency.

Customer complaint was received in case of Miranda Milk. Total

three consumers reported some chemical odour (stink / foul
8
smell) in milk. Company’s agent noted the complaint and replaced
the bags.
Test software used for machine alignment and linearity
9
measurement is not validated.
No investigation of root cause carried out for the rejection
10
received from customer.
Product under warranty failed in the field. Replacement and
11
repairs which was done by the organization is not effective.

12 Effectiveness on training given for house-keeping is not verified.

Welder qualification is not carried out for welding on flanges.

13
However experienced welders were doing it.
Non-conforming products reworked and sold under concession to
14
other customer.
Data collected over the period of time while reviewing the
15
measurable objectives were not analyzed.
 Few cases observed during the audit that employees of the
16 important functions are not aware about the customer
requirement and expectations.
Quality objectives were established at relevant functions within
17 the organization but there was no plan evident to achieve the
same.
When determining the various processes needed for QMS in an
18 organization, they did not identify the risks and opportunities
associated with these processes.
When establishing the scope of QMS, the organization did not
19 consider the internal and external issues as they did not
determine them.
There is no process in the organization to manage the QMS
20
changes.
Lessons learnt from failures and successes in the organization
21
were not shared within the organization.