Control of nonconforming outputs. ISO 9001:2015 clause 8.7.
Nonconformities
can occur in every process in a company. Standard requires nonconforming
outputs must be identified and controlled to prevent the nonconforming product
reaching to the cutometer.
Nonconformities
are further mentioned in ISO 9001:2015 clause 10.2 but the focus of that clause
in how the nonconformities will be resolved through corrective action while
this clause 8.7 defines in detail how nonconformity should handle before initiating
corrective action.
Control of
nonconformity outputs is important because delivery nonconforming products and
services will lead to dissatisfaction of your customer, penalties, and
lawsuits.
Action to
address nonconformities must be appropriate to the nature of the nonconformity
and its effects on product or service.
Nonconformity
outputs can be dealt in one or more following ways:
1- Correction.
In some
cases, nonconformity can be removed by simple correction. For example, some
parts of chairs produced by the furnishing company not glued properly. So, they
sent back for additional gluing.
After correction,
the company must verify that the corrected product is conforming to the
original requirements.
2- Segregation, containment, return or suspension of provision products and services.
For example,
during the food storage prior to deliver to the customer, the storage
temperature exceeding to the end value. This does not necessary mean that the
food is not fit to use but delivery process must be stopped, and food must segregate
from the other food and send for analysis.
3- Informing the customer.
The company
must determine if it is necessary to inform the customer about nonconforming
output.
For example,
if the company discover nonconformity after the products and services are
delivered or if the nonconformity will jeopardize delivery of products and
services.
4- Obtaining authorization for acceptance under concession.
In some
cases, delivery of nonconforming products can be allowed by the customer and in
such cases, the customer must provide to the company approval prior to delivery.
This usual happens
when the nonconformity of product original requirements is small and does not
significantly influence the characteristics.
These rules
apply to all nonconforming outputs and even to these that is discover after delivery
of products and services.
The standard
requires companies to keep records that describe nonconformity and action taken
to remove them. This usually done in the record called nonconformity record. And
this record must contain name of the authority deciding on the actions taken in
respect to nonconformity.