ISO 9001:2015 QMS Awareness – Operation – Release of product / service, Control of nonconforming outputs
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Release
of product / service
Release = Permission to continue
/ go to the next stage of a process
Release = Permission to
go to the next process
Release of product =
Process of delivering of the product
Release of service = Process
of delivering of the service
A product / service
release is the process of delivering a product / service to the customer. But a
release is much more than just the act of delivery. It involves ensuring that
the product / service meets predetermined quality criteria and has undergone
appropriate monitoring and measurement activities. For the customer (internal /
external), it is a promise of added value. A product / service release
signifies the completion of necessary activities and verification of conformity
to specified requirements.
The organization needs
to implement – Planned arrangements at appropriate stages. Purpose – To
ascertain that the product / service requirements are met.
The organization needs
to release product / service – Only when satisfying planned arrangement
implementation or approval by a relevant authority / customer.
The organization needs
to retain documented information (records) – Release of product / service and
also (i) Conformity evidence with accepted criteria, (ii) Person traceability authorizing
the release of the product / service.
Control of nonconforming
output
Output = Result of a
process
Nonconforming = Having
nonconformity
Nonconformity = Non-fulfilment
of a requirement
Nonconforming output = Result
of a process that has nonconformity
The organization needs
to ensure, identify and control – Nonconforming output (such result of a
process that has nonconformity). Purpose – Prevent unintended use / delivery of
nonconforming output.
The organization needs
to take appropriate actions – Based on the nature of nonconformity and its
effect on the product / service. This is also applicable to nonconforming
product / service detected after delivery of product, during / after the
provision of service.
The organization needs
to deal with nonconforming outputs in suitable ways – Ways to deal (one or
more) –
(i)
Correction of
nonconforming output,
(ii)
Segregation of the
nonconforming output,
(iii)
Containment of
nonconformity,
(iv)
Return of nonconforming
product / service,
(v)
Suspension of providing
product / service,
(vi)
Informing the customer,
(vii)
Obtaining authorization
for acceptance of the product / service under concession.
The organization needs
to verify after correction – Product / service conformity to requirements.
The organization needs
to retain documented information (records) – (i) Describing nonconformity of
the output, (ii) Describing actions taken, (iii) Describing any concessions
obtained, (iv) Identifying the authority deciding the action on nonconforming
output.
A few examples of action
to be taken may be as under –
(i)
If in a manufacturing process
a resulting output is produced or manufactured with a defect, the correction
involves reworking the output to rectify the defect and bring the nonconforming
output into conformance with the required needs and expectations of the output,
(ii)
When some of the
resulting outputs (goods / materials) are found to be damaged or nonconforming,
such nonconforming goods / materials are separated from the conforming goods /
materials and clearly marked or segregated to prevent unintended use or
distribution of nonconforming goods / materials.
(iii)
If a
nonconforming issue is identified in a particular manufacturing process,
containment measures may involve stopping the manufacturing process in that
line, quarantining the affected products, and preventing further distribution
until the cause of nonconformity is determined and appropriate corrective
actions are implemented.
(iv)
If a
customer receives a defective or nonconforming product, the organization may
arrange for its return and provide a replacement (conforming product) or refund.
(v)
If an
organization finds or discovers a critical flaw in its system or process, the
organization may temporarily suspend providing the product / service until the
issue is resolved.
(vi)
If a
nonconformity is identified in a product / service delivered to a customer, the
organization promptly communicates the nonconforming issue to the customer
including the nature of nonconformity and any necessary action being taken to
resolve it.
(vii)
There may
be situations where a nonconforming product / service cannot be turned into
full compliance with the specified requirements, but the product / service may
be acceptable for a specific purpose or with certain limitations. In such
situations, the organization seeks customer approval or a concession to
continue using or delivering the product / service while informing the nonconformity.
Think of
the following Questions
(1)
What is product / service release?
(2)
What is nonconformity?
(3)
What is nonconforming output?
(4)
How should an organization deal with
nonconforming output?
Best wishes,
Keshav Ram Singhal
Please have your comments /
reaction.
To train your employees with ISO
9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN:
B093YFFY7Z), which is available worldwide at Amazon. Please
search this Training Handbook in Amazon Website of your country.
You may also supply your
employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information
(eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/
(ii) Applying Risk-based Thinking in an Organization Implementing ISO
9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/
Thanks.
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