CLAUSE 8.

5 Production and Service Provision

8.5.1 Control of Production and Service

The organization should implement production and service

provision under controlled conditions. Include these
controlled conditions, as applicable:
1. availability of documented information that defines
characteristics of products and services.
2. availability of documented information that defines
activities to be performed and results to be achieved.
3. availability and use of suitable monitoring and measuring
resources
4. implementation of monitoring and measurement
activities at appropriate stages to verify that criteria for
control of processes and process outputs, and acceptance
criteria for products and services, have been met.
5. use and control of suitable infrastructure and process
environment for the operation of the process.
6. appointment of a competent person and, where
applicable, required qualification of persons;
7. validation, and periodic revalidation, of ability to achieve
planned results of any process for production and service
provision where the resulting output cannot be verified by
subsequent monitoring or measurement.
8. implementation of products and services release, delivery,
and post-delivery activities.

This clause provides a list of control requirements that you may use, if
applicable to your business. Identify and control all operational
processes. Show the interaction of these processes with other processes.
Use your product, project, or contract quality plan to control your
operational activities. Schedule your operations taking into
consideration customer delivery requirements, production capacity and
capability, material availability and usage, personnel availability and
usage; storage; etc.  Carefully define and document the interaction of
your operation scheduling process with your logistics processes such as
inventory management, customer communication, traffic and shipping
control, packaging and labeling, sales, and billing. Use quality plans to
control your operation processes. Quality plans address what has to be
made, how much has to be made, when it has to be made, by whom, in
what sequence, how it has to be made, what equipment to use, what
measurement and monitoring tools to use, what to inspect, when to
inspect, how much to inspect, what to do if problems arise, etc. Your
quality plan must cover all operation process steps from receipt of
materials, production, packaging, storage, delivery, and even post-
delivery activities such as installation or training. Your quality plans are
dynamic and must be updated for the changes in product specifications
or process parameters; resources used; monitoring or measurement
requirements, etc. Your quality plans should reference any work
instructions specified for the process steps. Work instructions may be
viewed as a subset of your quality plan and may relate to a specific task
or activity of your overall product realization process for e.g. setting up a
machine, performing an inspection, packaging a product, If you
determine that work instructions are needed at specific points in your
process, then they must be readily available and relevant i.e. current or
right version. Note that work instructions may exist in many forms such
as narrative, graphical, audio, video, physical display, etc. To improve
your QMS, it will be very useful to draw a flow chart to link the flow and
interaction of the activities and sub-processes covered by these clauses,
e.g. many organizations overlook reviewing and updating their quality
plans for corrective action taken to address a manufacturing process
problem. Operational personnel must have timely access to all
information relevant to their activities including specific work
instructions if necessary. There may be a serious risk to production flow
if such information is unavailable or untimely. You must identify and
document all processes addressing this clause as part of your QMS  For
these processes, you must also identify what specific documents are
needed for effective planning, operation, and control of production
activities. These documents may include – a product quality plan; work
instructions; documented procedure; etc., combined with unwritten
practices, procedures, and methods. Look at the risks related to your
product, processes, and resources in determining the nature and extent
of documented controls you need to have. Performance indicators to
measure the effectiveness of operational processes in meeting
requirements and achieving quality objectives should focus on reducing
variation in and improving production processes and related use of
resources.

Validation is usually required where the product cannot be verified

without damaging or destroying the product, e.g. some types of welding,
heat treatment, painting, electroplating, rust-proofing, etc. In such
instances, the quality of these activities may only be discovered after use.
This would generally not be accepted due to safety (e.g. weld) or
aesthetic (evidence of rust or dullness of chrome) reasons.  In the case of
a service such as pizza delivery within 30 minutes of order placement, if
the timeliness of delivery is not verifiable, then validation would be
required. However, most service-oriented businesses (e.g. delivery; call
center) have some form of monitoring during service execution to ensure
service quality. Validation involves conducting capability studies using a
combination of resources technology, equipment, materials,
environment, competent personnel, and production and testing methods
that consistently result in a quality product or service. Validation may
also require customer or regulatory approval of the process. You must
keep appropriate records of process validation showing both the
achievement of planned results as well as the ongoing maintenance of
such capability. If you change any part of the proven process capability
for e.g. materials, equipment or personnel, etc., you must revalidate i.e
re-prove the changed process. It is up to each organization to determine
what combination of resources and methods will provide the required
consistent process capability and quality of product or service. Include as
appropriate, these validation controls in your quality plans.

Product-related indicators may include a reduction in defect rates,

PPM’s (defective parts per million), scrap rates, waste and rework;
improvement in on-time delivery. Production process-related indicators
may include a reduction in set-up time, run rates, process cycle time,
production scheduling and operator errors and omissions, etc.

8.5.2 Identification and Traceability

The organization should use suitable means to identify

“process outputs” where necessary to ensure conformity of
products and services. The organization should identify the
status of “process outputs” with respect to monitoring and
measurement requirements throughout production and
service provision. The organization should control the unique
identification of “process outputs” where traceability is a
requirement. It should retain any documented information
necessary to maintain traceability. “Process outputs” are
results of any activities which are ready for delivery to the
customer or to an internal customer (e.g., the receiver of
inputs to the next process). “Process outputs” can include
products, services, intermediate parts, components, etc.

There are three distinct control requirements specified here.

 Product identification: It means knowing the identity of your or
customer-supplied product from incoming receipt of materials,  raw
material storage, use in production, work in progress, finished
product storage, and delivery of the product to the customer. Product
identification can be controlled using physical and electronic
methods.
 Product status: It means knowing the quality status (good or bad) of
materials and products through each of the above stages. Product
status can be controlled using physical and electronic methods.
 Unique Product Identification: It is not a mandatory requirement
under ISO 9001 unless contractually required by customers or
regulatory bodies. In certain industry sectors such as the automotive
or aerospace or pharmaceutical industry, unique product
identification is mandatory for safety, regulatory, and risk
management reasons. This usually involves keeping detailed records
of product manufacturer such as material, equipment, personnel,
processes, production, inspection and test details, etc., for individual
products or production batches. These records help to trouble-shoot
product and process problems, resolve customer complaints, and
enable continual improvement of product and process. In many
instances, it also reduces cost, risk, and use of resources by
narrowing the problem down to a specific cause or instance.
Depending on the product, the OEM may specify the degree of
unique identification and traceability required.
While this clause does not call for specific documented information,
these controls may be included in your Operation processes through your
product quality plans, work instructions, and other specific
documentation. Examples of product identification and test status
include physical tags, bar code labels linked to computer records; MRP
systems tracking specific production runs/lots,  automated production
transfer processes, etc. Performance indicators to measure the
effectiveness of processes that control identification and traceability may
include a reduction in identification errors and omissions; product
quality status errors and omissions; and traceability errors and
omissions.

8.5.3 Property Belonging to Customers or External Providers

The organization should exercise care with property

belonging to customers or external providers while under the
organization’s control or being used by the organization. The
organization should identify, verify, protect, and safeguard
the customer’s or external provider’s property provided for
use or incorporation into products and services. It should
report to the customer or external provider when their
property is incorrectly used, lost, damaged, or otherwise
found to be unsuitable for use. Customer property can
include material, components, tools and equipment,
customer premises, intellectual property, and personal data.

Customer or External provider property may include material,

production equipment, tooling, measuring and test equipment, facilities,
transport vehicles, returnable packaging, intellectual property such as
drawings, specifications or proprietary information, product returned for
servicing under warranty, product sent for outsourced work, etc.
All customer property is exposed to the risk of being damaged, lost,
misused, misplaced, stolen, become unsuitable or obsolete for use. You
must establish controls for each of these risks. Notify the customer/
External provider in writing if their property is lost, damaged, or
otherwise found to be unsuitable such as perishable past its shelf life for
use. Control to minimize the risks to customer/External provider
property include inventory management, preservation, and storage,
identification, status and traceability indicators, maintenance,
notification, traffic flow, authorized use, restricted access, etc. Marking
customer/External provider property with a unique identification
number that can be traced to a record that provides details of ownership
is one of many acceptable controls. While this clause does not call for
specific documented information, these controls may be included in your
product realization processes through your product quality plans, work
instructions, and other specific documentation. Many of the controls
needed for clause 8.5.2 Identification and traceability and clause 8.5.4
Preservation apply to customer property. The processes, controls, and
documentation for these other clauses could be expanded to include
customer property. Performance indicators to measure the effectiveness
of processes that control customer property may include a reduction in
identification errors and omissions, loss due to damage or unsuitability,
scrap, rejects, etc., as well as increased customer property turnover rates.

8.5.4 Preservation

The organization should ensure the preservation of “process

outputs” during production and service provision, to the
extent necessary to maintain conformity to
requirements. Preservation can include identification,
handling, packaging, storage, transmission or
transportation, and protection.

All raw materials, work in progress, finished product, supplies, customer

provided materials or product, product sent for outsourced work, etc.,
are subject to the risk of being damaged, lost, misused, misplaced, stolen,
become unsuitable, perishable, or obsolete i.e. past shelf life for use. This
could occur during receipt, handling, storage, use in production, and
transportation to the customer, etc. These could be controlled using
identification, status and traceability indicators, inventory cycle counts
and condition evaluation, stock rotation methods such as FIFO, just in
time, tracking shelf life,  special, controls for restricted access, handling
and storage of hazardous materials, climate and environment,
maintenance procedures, bar codes, training, use of special equipment
for handling, condition reports, etc. These controls may be included in
your product realization processes through your product quality plans,
work instructions, and other specific documentation. Many of the
controls needed for clause 7.5.3 Identification and traceability apply to
the preservation of the product.
Performance indicators to measure the effectiveness of processes that
control preservation of product may include a reduction in obsolete and
spoils materials an product (e.g., fresh produce, fruits, or frozen foods),
identification errors and omissions, rejects, waste, scrap, etc., and
increase in inventory turnover and material/product availability, and
product safety.

8.5.5 Post-Delivery Activities

The organization should meet requirements, as applicable,

for post-delivery activities associated with products and
services. In determining the extent of post-delivery activities
that are required the organization should consider risks
associated with products and services; Customer feedback;
legal requirements; nature, use, and intended lifetime of
products and services; Post-delivery activities can
include actions under warranty provisions, contractual
obligations (such as maintenance services)
and supplementary services (such as recycling or final
disposal)

Post Delivery activities mean based on customer agreement or other

agreement, the organization may be responsible for providing support
for their product or services after delivery. This could include technical
support, routine maintenance or total recall, recycling, reusable
packaging, returnable containers, etc. The extent of post-delivery activity
will depend on:
 Statutory and regulatory requirements:  If statutory or
regulatory requirements dictate post-delivery activities or warranties,
they must be addressed
 the potential undesired consequences associated with its
products and services:  The organization must consider potential
consequences, and how they intend to respond, the scope of their
reaction plan, etc
 nature, use and an intended lifetime of its products and
services:  This is very commonly stated in the organization’s return
policy or statement of liability.  Some organizations clearly state that
 there are no warranties (or post-delivery activities) offered,
expressed, or implied.  If this is the case (and in the absence of any
other requirements in this list), this section can be addressed simply
by acknowledging that there are no post-delivery activities.
 customer requirements:  If the customer requires post-delivery,
support, warranty, protection through delivery and receipt, etc, the
post-delivery activities should be clearly described.
 Customer feedback: Customer feedback should be considered
when determining the scope of post-delivery activities.  This also
implies that the scope of those post-delivery activities may change
over time in response to customer feedback.

8.5.6 Control of Changes

The organization should review and control changes for

production or service provision to the extent necessary to
ensure continuing conformity with requirements. The
organization should retain documented information
describing the results of the review of changes, personnel
authorizing the change, and any necessary actions arising
from the review.

The organization is required to review and control changes for all of the
previously discussed “production and service provision” topics including
8.5.1 Control of production and service provision (all of the controls
established in the first place), 8.5.2 Identification and traceability, 8.5.3
Property belonging to customers or external providers, 8.5.4
Preservation and 8.5.5 Post-delivery activities.  So, just as the QMS must
have defined each of these items, any changes to them must be
controlled. Changes that are not clearly communicated create confusion. 
Changes that have not been adequately reviewed and vetted may be
implemented and result in an undesired outcome.  Changes, in general,
create instability, and a robust change management process is critical to
ensure changes are fully reviewed, approved, communicated,
understood, and validated when they are implemented. Records
describing the results of the review of changes, personnel authorizing the
change, and any necessary actions arising from the review have to be
maintained.
8.6 Release of Products and Services

The organization should implement planned arrangements at

appropriate stages to verify product and service
requirements have been met. Retain evidence of conformity
with acceptance criteria. The release of products and services
to the customer should not proceed until the planned
arrangements for verification of conformity have been
satisfactorily completed unless otherwise approved by a
relevant authority and, as applicable, by the customer.  The
organization should retain documented information for
traceability to the person(s) authorizing the release of
products and services for delivery to the customer. The
organization should also retain documented information for
evidence of conformity with the acceptance criteria. 

You must identify, monitor, and measure product/service characteristics

to verify conformity to requirements. Product characteristics may be
dimensional, functional, performance, reliability, durability,
maintainability, life, cost, etc. Requirements may come from your
customer, your own organization, regulatory and industry sources. You
must plan what characteristic(s) to measure, type of measurements,
what measurement device to use, how often to measure, sample size,
acceptance criteria, and records needed for each product or product type.
Use your quality plan to document these controls. Your product, project,
or contract quality plan must define the stages at which various
monitoring and measurement will be carried out at incoming receipt of
materials from suppliers or outsourced work, storage, internal
production processes, finished product, packaging, at time of shipping
and post-installation. Monitoring and measurement may be done by
your personnel, subcontracted or outsourced labor, or by the customer.
You must ensure that all personnel performing monitoring and
measurement are trained and competent.
If you plan on releasing during any stage of production or shipping
finished product, where all planned inspections and measurements to
that stage have not been completed, ensure that you obtain prior written
approval/waiver from a relevant internal authority or the customer.
Where practical, consider completing all missed planned inspections and
measurements before product delivery. You must identify and document
all product realization processes that may address this clause, as part of
your QMS, e.g. receiving, production, shipping, etc. For such processes,
you must also identify what specific documents are needed for effective
planning, operation, and control.
You could use a product quality plan, any documented information, or
other combination of specific practices, procedures, and methods. Look
at the risks related to your product, processes, and resources in
determining the extent of documented controls you need to have.
Performance indicators to measure product conformity may include a
reduction in defect rates, PPM’s (defective parts per million), scrap rates,
waste, rework, improvement in on-time delivery, product returns from
the customer, etc. Performance indicators to measure the effectiveness of
product realization processes in achieving product conformity include
productivity, reduction of cycle time, errors, omissions, and failures, etc.