ISO
9001:2015 QMS Awareness – Operation – Production and service provision
===========
Production
and service provision
Let us first understand,
what is the meaning of production and service provision.
Production refers to the
activities involved in manufacturing, assembling, and delivering a product. Production
encompasses the transformation of inputs into tangible goods. Welding,
painting, storing, handling, packaging etc are part of production activities.
Service provision refers
to the activities involved in providing intangible services to a customer. It
includes any process that contributes to the delivery of service, for example,
providing analysis, coding, testing etc to the customer.
Production and service
provision are critical elements of an organization’s operations and require
effective execution, such as controlling resources, equipment, methods,
processes, persons involved in operation activities.
Production and service
provision also include identification, traceability, use of customer / external
provider property, preservation, and post-delivery activities.
Controlled
conditions are necessary to ensure that production and service provision
consistently meet the organization and customer requirements.
Identification
= The act of finding out who someone is or what something is = The act of
identifying (recognizing) someone or something
Identification
of product / component / equipment can be in the form of labels, tags, or
markings.
Traceability
= Ability to trace something as it moves through a process
Traceability
= Ability to trace the history, application or location of an object.
Traceability
can relate to – (i) the origin of materials and parts, (ii) the processing
history, (iii) the distribution and location of the product / service after
delivery.
Traceability is the
ability to trace something as it moves through a process.
Control
of production and service provision
The
organization needs to implement – Production / service provision under
controlled conditions.
Controlled
conditions to include (as applicable):
(1)
Define in
a documented information (and make its availability) – (i) Characteristics of
product / service, (ii) Characteristics of activities to be performed, and
(iii) Results to be achieved,
(2)
Availability
and use of suitable monitoring / measuring resources,
(3)
Implementing
monitoring / measurement activities at appropriate stages to verify meeting
criteria of control (of process / output) and acceptance criteria for product /
service,
(4)
Use of
suitable infrastructure and environment for process operation,
(5)
Appointment
of competent (and qualified) persons,
(6)
Validation
and periodic re-validation of process ability to achieve planned result (where
resulting output cannot be verified by subsequent monitoring / measurement,
(7)
Implementing
actions (to prevent human error),
(8)
Implementing
release / delivery / post-delivery activities.
Identification
and Traceability
The
organization needs to use suitable means to identify (recognize) outputs when required
to ensure the product / service conformity.
The organization
needs to identify (recognize) the output status (position) with respect to
monitoring and measurement requirements.
The
organization needs to control the unique identification of output, when traceability
is a requirement.
Customers’
/ External providers’ property
The
organization needs to – (i) Exercise care while under the organization’s
control or being used, (ii) Identify, verify, protect and safeguard, (iii)
Report to the customer / external provider when such property is lost, damaged
or otherwise noticed unsuitable for use.
Preservation
The
organization needs to – Preserve outputs (to the extent necessary (to include
identification, handling, contamination control, packaging, storage,
transmission or protection) during production / service provision. Purpose –
Ensure conformity to requirements.
Post-delivery
activities
The
organization needs to consider – (i) Legal requirements, (ii) Potential
undesired consequences associated with the product / service, (iii) Customer
requirements, (iv) Customer feedback, (v) Nature, use, and intended life of
product / service.
The
organization needs to determine – Post-delivery activities including warranty
provisions, contractual obligations, such as maintenance, recycling / final
disposal supplementary services.
The
organization needs to meet requirements for post-delivery activities.
Control
changes
The
organization needs to review and control – Changes for product / service
provision. Purpose – Continuing conformity with requirements.
Documented
Information
The
organization needs to retain documented information (records) – (i) Necessary
to make sure traceability, (ii) What happened to customer / external provider
property? (iii) Describing results of the review of changes, (iv) Describing
personnel authorizing change, and (v) Describing any necessary actions arising
from the review.
Think of
the following Questions
(1)
What do you understand by production and
service provision?
(2)
Is meeting traceability requirement always
necessary?
(1)
What documented information you may need to
retain for production and service provision?
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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