ISO 9001:2015 CLAUSE 7 SUPPORT
CLAUSE 7 SUPPORT
After addressing the context, commitment
and planning, organizations will have to look at the support needed to
meet their goals and objectives. This includes resources, targeted
internal and external communications, as well as documented information
that replaces previously used terms such as documents, documentation and
records. The organisation needs to supply competent resource to deliver
its goods and services. Again, nothing new here, awareness has been
strengthened so now everyone needs to know the implications of not
conforming to the management system requirements. The organisation needs
to consider the need for both internal and external
communications relevant to the management system – what, when and with
whom it will communicate. The final support requirement is going to
generate a lot of heat but not much light – documented information.
Gone are the terms documents, documentation and records. However
the requirements for the management of documented information are not
new, exceptional or excessive. One skeleton which is finally laid to
rest is the idea that everyone needs work instructions no matter how
experienced or senior they are in the organisation. Auditing awareness
and communication should be easier; the requirements are crisper. The
organization needs to:
- Determine and provide the resources needed for the establishment, implementation,maintenance and continual improvement of the management system.
- Determine the necessary competence of person(s) doing work under its control that affects its discipline specific performance.
- Ensure that these persons are competent on the basis of appropriate education, training,or experience.
- Where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken
- Retain appropriate documented information as evidence of competence
7. Support
- 7.1 Resources
- 7.1.1 General
- 7.1.2 People
- 7.1.3 Infrastructure
- 7.1.4 Environment for the Operation of Processes
- 7.1.5 Monitoring and Measuring Resources
- 7.1.6 Organizational Knowledge
- 7.2 Competence
- 7.3 Awareness
- 7.4 Communication
- 7.5 Documented Information
For purpose of this article only, I have rearrange clause 7 Support as
7. Support
- 7.1 Resources
- 7.1.1 General
- 7.1.3 Infrastructure
- 7.1.4 Environment for the Operation of Processes
- 7.1.5 Monitoring and Measuring Resources
- 7.1.2 People
- 7.2 Competence
- 7.3 Awareness
- 7.4 Communication
Clause 7.1.6 Organizational Knowledge is a separate article.
7.1 Resource
In addition to clause 7.1, there are other references to resources throughout the standard, for example:
4.4.d – determine the resources needed for QMS processes and to ensure their availability
5.1.1.e– top management ensure resources needed for QMS are available
6.2.2.b –The organization should determine what resources are needed to achieve quality objectives
6.3.c –The organization should consider availability of resources for planning any changes in QMS
8.1.c –the organization should determine any resources needed to achieve conformity to product and service requirement.
8.3.2.e – the organization should consider the internal and external resource needs for design and development of product and services.
8.5.1.b – the availability and use of suitable monitoring and measuring resources
9.3.2.d – management review of adequacy of resources
9.3.3. – management review of resource needs
5.1.1.e– top management ensure resources needed for QMS are available
6.2.2.b –The organization should determine what resources are needed to achieve quality objectives
6.3.c –The organization should consider availability of resources for planning any changes in QMS
8.1.c –the organization should determine any resources needed to achieve conformity to product and service requirement.
8.3.2.e – the organization should consider the internal and external resource needs for design and development of product and services.
8.5.1.b – the availability and use of suitable monitoring and measuring resources
9.3.2.d – management review of adequacy of resources
9.3.3. – management review of resource needs
7.1.1 General
The organization should
determine and provide resources needed to establish, implement,
maintain, and continually improve the QMS. And should consider the
capabilities of, and constraints on, existing internal resources;
and what needs to be obtained from external providers.
This clause updates the ISO 9001:2008
clause 6.1 on Resources. It removes any mention of resources for
customer satisfaction. Customer satisfaction is mentioned at multiple
clauses, including 9.1.2. It adds consideration of internal resources
and external providers. Additional resource considerations are the
capabilities of, and constraint on existing internal resources and
what needs to be obtained from external providers.
Top management has the responsibility to
ensure the availability of resources to develop and maintain your QMS.
Clause 7.1 requires you to determine the nature and availability of such
resources. This is typically done through business and quality
planning. Having adequate resources is vital to ensure product
conformity or satisfy customer requirements – e.g. having adequate
personnel, materials and equipment to ensure timely production and
delivery of product. Use business planning (clause 5.1.1), quality
management planning (clause 6.2.2) , planning for QMS processes (clause
4.4), and also during planning for any change in QMS(clause 6.3) to
identify and determine the nature of resource needs of QMS each process
and plan for its availability. The actual amount of resources needed
may vary day to day and over time. This is one reason why top management
must review QMS performance regularly(clause 9.3.3). While planning for
your resources needed the organization must consider what existing
internal resources it has considering its capabilities and constraints
and what needs to be obtain by external providers. Consider developing
performance indicators for each major category of resources used, (e.g.
machinery and equipment; human resources; facility and environment;
transport; communication systems; etc.) to determine the effective use
of such resources. This applies even in case the resources is being made
available by external provider. Where the resource planning process is
performed off-site (e.g. at head-office), your QMS must include the
off-site processes within your QMS and ensure that such processes comply
with ISO 9001 requirements. Evidence of the off-site facility’s
compliance may include – a copy of their ISO 9001 certification; results
of their internal audits to ISO 9001; auditing the outsourced facility;
etc.The expectation is to flow down to the off-site facility, the
relevant ISO 9001 requirements that you would have to implement, had you
carried out the process at your own facility.
7.1.3 Infrastructure
The organization should
determine, provide, and maintain the infrastructure for the operation of
the processes to achieve conformity of products and
services. Infrastructure may include buildings and associated
utilities; equipment including hardware and software; transportation
resource ; information and communication technology.
The only relevant requirement is
that we must “determine, provide and maintain” that which is necessary
to make conforming products and services requirement. Compliance to
this requirement would require evidence that the organization has,
“determined”, and then continues to “provide and maintain” the required
infrastructure. This need not be a document and consensus among those
interviewed will suffice. This also assumes there is consensus that the
infrastructure is reliable based on its maintenance.
Planning for the types of infrastructure
resources needed for your business may include facility, production
equipment, IT equipment and software, laboratory, packaging, dies,
molds, tooling, jigs, fixtures, storage, transportation, communication,
office, materials, labor, utilities and supplies, etc. The key strategic
business factors to be considered for infrastructure planning include
future needs, current availability and capacity, cushion for growth,
contingency planning, linkage to current and future product programs.
This planning may be done through business planning (clause 5.1.1),
quality management planning (clause 6.2.2) , planning for QMS processes
(clause 4.4), and also during planning for any change in QMS(clause
6.3). The actual deployment of such resources may be determined by each
process owner. You are required to maintain your infrastructure. Your
planned preventive maintenance program should include controls for
schedule and timing, availability and training of personnel, types and
scope of maintenance, maintenance and competency/training records,
tracking to maintenance objectives, use, storage and control of spare
parts, control of any maintenance outsourcing etc.
The notes identifies the types of infrastructure that might be considered:
- Buildings and associated utilities – Is the building and equipment suitable? For example, if you are manufacturing metal stampings or storing metal products, a leaky roof, non-enclosed travel paths between buildings, etc may not be suitable to ensure you can consistently provide conforming products (if “rust free” is a requirement). Water treatment services, beyond public water/sewer may be required to ensure regulatory compliance where processes produce waste water unsuitable for discharge into the sewer, etc. This should be the focus of consideration for buildings and associated utilities. Some auditors may inquire as to contingency plans to ensure your infrastructure is maintained. Most organizations have at least a basic contingency plan either for compliance or customer assurance.
- Equipment including hardware and software – This is pretty obvious that the organization must have the proper equipment, however the addition of the “hardware and software” wording has given pause to quite a few both in the 2008 version and in this one. The intent is that the organization understand their equipment, but also maintain and upgrade as appropriate, the related software. This may be specific to a piece of manufacturing equipment within the building, a measuring system or device in the lab, or it may also be the organization’s ability to meet the customers’ needs with regard to communication (such as being able to send/receive design files, programs for programmable machinery, etc). And the expectation is that someone knows the status of these items and has a plan to maintain them.
- Transportation – Again, this is pretty obvious. If product must be maintained at a certain temperature, for example, the proper fleet (either internal or by an external provider) must be maintained. If a certain number of trips is required to provide just-in-time delivery, a scheduling process must be maintained, etc. And there should be a contingency plan in the event of service interruption.
- Information and communication technology – Customer requirements often specify their preferred method of communication and order processing, and the organization must be able to meet their criteria (ie – electronic purchase orders & acknowledgements, advance ship notices, electronic billing, etc)
7.1.4 Environment for the Operation of Processes
The organization should
determine, provide, and maintain environment necessary for the operation
of processes and to achieve conformity of products and services. A
Suitable environment for operation of processes can be a combination of
human and physical factors such as social (for e.g.
non-discriminatory, calm, non-confrontational etc), psychological (for
e.g. stress reducing, burnout prevention, emotional protective),
physical (for example, temperature, heat, humidity,light,
airflow,hygiene, noise). These factors can differ depending on type of
product and service provided by the organization
The organization shall determine,
provide and maintain the environment necessary for the operation of its
processes and to achieve conformity of its goods and services. The
“NOTE” adds, “physical, social, psychological, environmental and other
factors (such as temperature, humidity, ergonomics, and
cleanliness)”.The clause NOTE adds social and psychological
environments, adds factors of ergonomics and cleanliness, and drops the
examples of noise, lighting, and weather from the ISO 9001:2008
standard. Environment for operation of process is Work Environment which
includes controls for ergonomics, personnel safety and facility
conditions that are conducive to achieving product quality. Some of the
factors to consider in determining and managing the work environment
include ergonomics (worker movement; fatigue; manual effort and loads,
etc), workplace location, heat, light, humidity, airflow, noise,
vibration, hygiene, cleanliness, pollution, adequate facilities
(lockers, lunchroom, cafeteria, washrooms etc); health and safety
regulations; cleanliness of premises; etc. the extent to which the above
environmental factors may apply to any organization will vary based on
size, risk and other considerations. The ISO 9001:2015 also wants the
organization to look into social issues such as non discriminatory
environment, and also a clam and non confrontational environment.
psychological Issues such as stress-reducing, burnout prevention and
emotionally protective etc. should also be not ignored by the
organization. The focus should be employee safety, welfare and product
conformity. Performance indicators to measure the effectiveness of
processes that determine and control the effective use of
infrastructure may include equipment maintenance – uptime / downtime;
productivity – equipment and workforce; accident and safety incidents;
non-value added use of floor space; excessive handling and storage;
number of instances specific resources were not available or delayed;
Though there is no need for a documented information requirement, social
and psychological surveys can be shown as objective evidence in these
areas.
7.1.5 Monitoring and Measuring Resources
7.1.5.1 General
The organization should
determine and provide the resources needed for valid and reliable
monitoring and measuring results ,where monitoring or measuring is used
for evidence of conformity of products and services to specified
requirements. The organization should ensure that the resources provided
are suitable for type of monitoring and measurement activities being
undertaken and are maintained to ensure continued fitness for their
purpose. The Organization should retain appropriate documented
information as evidence of fitness for purpose of monitoring and
measurement resources.
7.1.5.2 Measurement Traceability
Where measurement
traceability is a requirement(statutory or regulatory or customer or
relevant interested party expectation) or considered by the organization
to be an essential part of providing confidence in the validity of
measurement results, measuring instruments must be verified or
calibrated at specified intervals or prior to use against measurement
standards traceable to international or national measurement standards.
The organization must retain the basis used for calibration or
verification as documented information if no such standard exists as a
documented information. Measuring instruments must be identified in
order to determine their calibration status; It must be safeguarded from
adjustments, damage, or deterioration that would invalidate calibration
status and subsequent measurement results. The organization should
determine if validity of previous measurement results has been adversely
affected when an instrument is found to be defective during its planned
verification or calibration, or during its use, and take appropriate
corrective action as necessary.
This clause is specifically about
monitoring product and service for conformity. This clause replaces old
clause 7.6 on Control of Monitoring and Measuring Equipment and is one
of the structural changes in the 2015 revision. the use of the term
“equipment” has been changed to “resources”. It needs evidence of the
fitness for purpose of the resources. Humans may carry out the activity
without equipment. Calibrated equipment now termed “instruments”.
Monitoring and measuring the quality system has a whole clause
(9 Performance Evaluation) dedicated to it. This clause is sticking
only with monitoring and measuring devices and equipment used to monitor
the product (or service). So, the organization must ensure they have
identified and put in place the appropriate resources including (7.1.2
People, 7.1.3 Infrastructure, 7.1.4 Environment) and now 7.1.5
Monitoring and measuring resources.
Requirements for what needs to be
measured and the acceptance criteria may come from the customer,
regulatory, industry and your own organization. Product realization
planning must determine the following what specific product and process
characteristics needs to be monitored and measured, the criteria for
product acceptance, the type of Monitoring and Measurement Device
needed, frequency i.e. at what stages of realization to do it, sample
size, etc. You must then determine what Monitoring and Measurement
Device is appropriate for each measuring or monitoring requirement.
Consideration must be given to the measurement capability (precision) of
the Monitoring and Measurement Device which may have to be several
times greater than the tolerance criteria for product measurement. This
would depend on the industry you are in and the criticality of end use
for the product for e.g. the precision requirements for ball bearings
may be much greater than say for cutting cloth to make a shirt.
Personnel using Monitoring and Measurement Device’s must have competence
and training in the use of Monitoring and Measurement Device’s in terms
of their function, range and precision of measurement, reliability, use
and maintenance.Monitoring and Measurement Device’s may include
measurement and testing tools, equipment, hardware and software. They
may be owned by your organization, your employees or the customer.
Monitoring and Measurement Device’s may be used to verify product as
well as to measure process conformity for e.g. a temperature controller
on an oven. Besides Monitoring and Measurement Device’s used for
product conformity, you may need to calibrate and control certain
Monitoring and Measurement Device’s used in related and peripheral
processes such as production equipment, tooling, maintenance, etc. To
ensure valid measurement and monitoring results, Monitoring and
Measurement Device’s must be controlled. A process is required, to
control the identification of monitoring measurement, selection,
purchase, status, identification, calibration, verification, adjustment
or re- adjustment, use, handling, maintenance and storage, training,
handling of nonconforming Monitoring and Measurement Device’s, etc. You
must keep appropriate records to demonstrate effective operation and
control of your Monitoring and Measurement Device processes. These
records must include calibration and verification records traceable to
national, international or other benchmark used for calibration.
All Monitoring and Measurement Device’s
used for product verification must be capable of being calibrated,
verified or both. Calibration is setting or correcting an Monitoring and
Measurement Device, usually by adjusting it to match or conform to a
dependably known and traceable standard for e.g. adjusting a micrometer
or caliper to conform to master blocks traceable to national
standards. Verification is confirming that the Monitoring and
Measurement Device is meeting or performing to acceptable national
measurement standards and does not involve any correction or adjustment
for e.g. verifying a ruler or tape measure against a calibrated ruler
that has been calibrated to a national standard. A ruler or tape measure
is generally not capable of being calibrated and when it gets out of
calibration its use must be discontinued. There are Monitoring and
Measurement Device’s that are capable of being both calibrated and
verified for e.g. a CMM- coordinate measuring machine and may require
both to be done in specific situations based on frequency of use and
criticality of measurement. This requirement also applies to the use of
computer software whose capability and calibration status must be
established prior to initial use and reconfirmed (verified) at defined
intervals.
You must define the frequency and method
of calibration for each type and level i.e. whether used in shop floor,
laboratory or standard of Monitoring and Measurement Device. Your
calibration records must identify what standard you used for calibration
and show traceability of the standards you use at your facility to
national or international standards. In rare circumstances, national or
international standards may not exist for calibrating a specific
Monitoring and Measurement Device. In such situations consider using
industry, manufacturer or even your own organizational standard to
validate the accuracy and reliability of your Monitoring and Measurement
Device. Consult with your customer if the contractual circumstances
require it. Your quality plan must define the measurement and
monitoring required and the type of Monitoring and Measurement Device
needed for it, including the frequency of measurement and acceptance
criteria. Depending on the risk and precision and reliability of
measurements needed, you might consider doing statistical studies on
Monitoring and Measurement Device’s referenced in your quality plans.
Ensure that personnel performing such statistical studies are trained
and competent to do so. A multitude of software tools are available to
manage and control Monitoring and Measurement Device’s. There are many
acceptable methods to identify Monitoring and Measurement Device’s and
their calibration status. The methods you select must consider the
manufacturers recommendations, frequency of use, environment the
Monitoring and Measurement Device is used in, risk in misuse or
incorrect tool being used, etc. Where an Monitoring and Measurement
Device is found to be out of calibration, you must take appropriate
correction action to contain and re-verify the product affected, to the
extent practical. This is in addition to containing, repair and
recalibration of the defective Monitoring and Measurement Device.
Customer or internal engineering changes may result in a change in
product measurement, requirements and/or the Monitoring and Measurement
Device to be used. These changes would normally be reflected in your
quality plan. If you use external calibration services, you are still
expected to impose the specific control requirements of this clause to
the external organization. If the nature of your business does not
require the use of Monitoring and Measurement Device’s for e.g. a
financial service such as a credit counseling service, then you must
clearly state this exclusion to your QMS scope, in your Quality manual.
Performance indicators such as the monthly trends in the number of out of calibration Monitoring and Measurement Device’s, or the number of Monitoring and Measurement Device’s past their calibration due date, number of Monitoring and Measurement Device’s being used and not controlled, reduction in untrained personnel found using Monitoring and Measurement Device’s, etc. Use these indicators to tighten and improve the effectiveness of your Monitoring and Measurement Device process. You could use a product quality plan, documented procedure or other combination of specific practices, procedures, documents 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 such as the monthly trends in the number of out of calibration Monitoring and Measurement Device’s, or the number of Monitoring and Measurement Device’s past their calibration due date, number of Monitoring and Measurement Device’s being used and not controlled, reduction in untrained personnel found using Monitoring and Measurement Device’s, etc. Use these indicators to tighten and improve the effectiveness of your Monitoring and Measurement Device process. You could use a product quality plan, documented procedure or other combination of specific practices, procedures, documents and methods. Look at the risks related to your product, processes and resources in determining the extent of documented controls you need to have.
The organization should ensure that the
resources provided are suitable for the specific type of monitoring and
measurement activities being undertaken. The organization should have
the right instruments and equipment on hand and they must be capable of
determining “good” from “bad”. The word “suitable” provides the
expectation that the instruments be accurate, reliable and precise
enough to make appropriate judgments about product (and services). This
includes the very common disciplines of calibration, reproducibility
& reliability studies, etc to ensure the instruments used to measure
product (and service) are suitable. They should be maintained to
ensure their continued fitness for their purpose. Once the organization
have selected and confirmed the appropriate monitoring and measuring
devices, they must have a surveillance program to ensure their continued
suitability. The organization should retain appropriate documented
information as evidence of fitness for purpose of monitoring and
measurement resources. There should be documented records of these
activities. Where measurement traceability is a statutory or regulatory
requirement a customer or relevant interested party expectation or
considered by the organization to be an essential part of providing
confidence in the validity of measurement results, measuring instruments
must be verified or calibrated at specified intervals or prior to use
against measurement standards traceable to international or national
measurement standards. Where no such standards exist, the basis used
for calibration or verification shall be retained as documented
information. There must be a generally accepted calibration program
which should always include traceable standards and a schedule for
verification/calibration. The use of traceable standards is
required because simply having something to measure your devices by does
not necessarily ensure an adequate calibration program. For example,
using old worn gauge blocks, pins, hardness standards, etc is not a best
practice. Your standards (in addition to your instruments) should be
maintained and traceable to an international standard to ensure the
validity of your monitoring and measuring program. The devices must
be identified in order to determine their calibration status; This is
the simplest thing to do – a simple calibration sticker will suffice.
Keep in mind that it is NOT required that stickers be on every device,
but why not do it? If each instrument has its own unique
serial number and is properly identified and can be cross-referenced to
its calibration status, that meets compliance requirements. However,
auditors just feel a better warm and fuzzy feeling if there is a sticker
including “last calibrated” or “next calibrated”. And even if you do
have a database or master list of instruments which tells you the status
of each instrument, a quick glance at the instrument itself doesn’t
hurt to ensure your instruments are maintained 100% of the time. The
devices must be safeguarded from adjustments, damage or deterioration
that would invalidate the calibration status and subsequent measurement
results. Safeguarding from damage and deterioration is the simplest of
these three. Obviously protective cases, protective films, filters, etc
keep an instrument in its tip top condition. Regular maintenance helps
too – removable of dust, atomized grease, etc. Safeguarding from
adjustments is a little more difficult, but can be easily achieved by
removing adjustment tools from general use, using seals on access
panels, etc. Most auditors are reasonable with regard to this, however,
if someone wanted to make an adjustment to an instrument, there are
many ways to work around the safeguards. It is unlikely to happen, and
between calibration checks can add an additional assurance that
instruments are safeguarded against adjustments.The organization should
determine if the validity of previous measurement results has been
adversely affected when an instrument is found to be defective during
its planned verification or calibration, or during its use, and take
appropriate corrective action as necessary. The addition of intermittent
checks (between calibration checks) helps to mitigate the impact should
an instrument be found to be out of calibration. For example, if a
micrometer is calibrated monthly and on today’s monthly check it is
found to be out of calibration, every measurement it has taken for the
past 30 days must be validated. This can require isolation of product,
product recall, etc in the absence of any other evidence of compliance.
Between calibration checks help to detect adjustments, errors,
etc. ISO9001:2008 used to include a reference to the “ability of
computer software to satisfy the intended application shall be
confirmed.” This was an attempt to ensure that dependence on software
be confirmed (rather than simply taking a computer’s word for it). The
idea was to prove out software and use common sense before turning it
over. For example, implementing the use of a coordinate measuring
machine requires a great deal of validation. A poorly programmed
measuring routine can result in a software rejecting “good” parts due to
measurement or calculation errors. This section was intended to
prevent that. However, the language was not clear and was often met
with blank stares by those who were asked to demonstrate compliance in
this area. So the specific reference to software was removed. The use
of the word “suitable” in the beginning of this section applies to all
monitoring and measuring equipment (including software), so the removal
of it has little or no real effect.
7.1.2 People
The organization should
determine and provide the persons necessary for the effective
implementation of its QMS and also for operation and control of its
processes.
7.2 Competence
The organization
must determine the necessary competence of person(s) doing work under
its control that affects the performance and effectiveness of its QMS;
It must ensure that ensure that these persons are competent on the
basis of appropriate education, training, or experience and
where applicable, take actions to acquire the necessary competence, and
evaluate the effectiveness of the actions taken; It must retain
documented information as evidence of competence. Applicable actions can
include, for example, training, mentoring, or reassignment of currently
employed persons; or hiring or contracting of competent persons. “Competence”
is defined in the section on terms as the ability to apply knowledge
and skills to achieve intended results. Demonstrated competence is
sometimes referred to as “qualification”.
7.3 Awareness
Persons doing work under the
organization’s control must be aware of the quality policy; relevant
quality objectives; their contribution to effectiveness of the QMS,
including benefits of improved quality performance; and
the implications of not conforming with system requirements.
This clause requires to determine what
is needed/necessary. Ensure persons are competent to meet those needs.
Where there are gaps, fill the gaps. And maintain records. Top
management is responsible for ensuring the availability of resources
which includes HR. Clause 5.3 requires top management to define the
organization roles and its responsibilities and authorities. Clause
7.1.2 required that adequate Human Resources be determined and
provided. And here in clause 7.2 the specific requirements for
controlling HR are defined. In clause 7.3 awareness needed by the
personnel working under its control are defined. Planning for HR process
controls must include determining competency criteria, skills
evaluation, identification of training needs, types of training,
provision of training, how training effectiveness is evaluated, methods
to communicate awareness of the importance of quality requirements and
meeting quality objectives, to all employees. Although training may end
up being the best solution, don’t overlook other actions, such as,
changing processes, improving procedures, rotating jobs, outsourcing, or
recruiting fully trained and competent people. Criteria for competency
must be developed based on appropriate education, skills, training and
experience for activities, tasks, functions and processes. The level and
detail of such qualifications, skills, training and experience will
depend upon the complexity of product, process, technology and customer
and regulatory requirements. It is up to your organization to determine
the necessary criteria for the various functions and activities
affecting product and QMS based on these factors. A “Skills Matrix” is a
useful tool used by organizations to determine and manage the
competency levels required by different activities and functions. An
organization may create a comprehensive training program that is fully
integrated with the quality management system. It should begins with
the identification of processes. Then the processes are described and
that becomes the basis of the training program – ensuring the persons
performing the work understand the processes and are competent to
perform them. And as persons are chosen and assigned to processes, they
are evaluated based on their previous education and experience versus
the requirements of the process, and where gaps are identified, they are
provided with additional training.
Organizations undergo significant
changes through growth or decline, acquisitions, new technology and new
products and processes, Also, many organizations are now outsourcing
their production labor to save on payroll costs and benefits. Labor
related nonconformities can easily arise in such cases. Planning for
your HR process must ensure that contract and agency personnel
performing work affecting product quality have adequate competency and
training. Appropriate records must be kept of such training.
Quality awareness must be focused on
meeting customer and regulatory requirements and Quality objective.The
organization must also promote awareness of its quality policy. The
process to promote quality awareness may include the use of methods such
as – cross-functional teams, involvement in quality planning, quality
circles, improvement suggestions, product workshops, zero defect
programs, product review checklist etc. QMS personnel must be motivated
to achieve the organization’s quality objectives. The process to
motivate employees may include the use of methods such as – employee
recognition awards, ongoing training programs, performance reviews,
employee surveys, poster campaigns etc,. You must determine and keep
appropriate records of education, training, skills and experience. These
records must demonstrate the effective operation of HR process
controls. Performance indicators to measure the effectiveness of the HR
process in determining competency and training needs of the workforce,
could include – employee turnover, employee complaints, number of
instances unqualified personnel were found performing QMS activity,
number of instances competency criteria were not met and number of
instances no training or competency records maintained; etc.
7.4 Communication
The organization should
determine the internal and external communications relevant to the QMS,
including: on what it will communicate; when to communicate; with whom
to communicate; how to communicate.
Communications is a complex and
difficult activity. Poor communication leads to chaos, poor performance,
poor morale and other bad things. Good communication can foster a
sense of community, teamwork and a clear sense of purpose and
direction.The organization must decide what, when, with whom and how we
will communicate both internally and externally. Problems may arise due
to incomplete, ambiguous or inaccurate information being transmitted;
transmission to the wrong person, too late or at the wrong time; use of
inappropriate or unreliable media, etc. Communication problems are
probably the most common cause of QMS nonconformities. Tracking some of
the more serious communication issues could serve as useful performance
indicators to determine and improve communication process
effectiveness. Clause 4.4 control of processes requires you to determine
the sequence and interaction of QMS processes. Each process requires
inputs to flow from one process and outputs to flow to another process.
There is a continuous (communication) flow regarding tangible (materials
and product) and intangible (information) inputs and outputs taking
place within your organization.
Top management must plan for internal and external communication methods and resources at the high level using the business planning process and deploy these methods though the information technology, logistic and HR processes.Each process owner must identify the methods of communication such as computer, documents, telephone, meetings, directives, visual, etc,used and determine whether these methods are appropriate and are they effective for the purpose intended? – (do they prevent non-conformities from arising due to the reasons mentioned above?). Process owners should provide feedback on communications effectiveness to the processes providing and controlling such resources. Communication by the MR on the effectiveness of the QMS must not only take place at the top management level but also at appropriate levels within the organization. If everyone is responsible for quality, then all process owners as well as their personnel are entitled to receive periodic feedback on their areas of responsibility.
Top management must plan for internal and external communication methods and resources at the high level using the business planning process and deploy these methods though the information technology, logistic and HR processes.Each process owner must identify the methods of communication such as computer, documents, telephone, meetings, directives, visual, etc,used and determine whether these methods are appropriate and are they effective for the purpose intended? – (do they prevent non-conformities from arising due to the reasons mentioned above?). Process owners should provide feedback on communications effectiveness to the processes providing and controlling such resources. Communication by the MR on the effectiveness of the QMS must not only take place at the top management level but also at appropriate levels within the organization. If everyone is responsible for quality, then all process owners as well as their personnel are entitled to receive periodic feedback on their areas of responsibility.
Example: Communications
| Entity | What | When | How/ How OFTEN | Who |
|---|---|---|---|---|
| Customer |
|
|
|
Marketing Manager/customer executive |
| Suppliers |
|
|
|
Purchasing Manager/ Purchasing executive |
| Staff |
|
|
|
HR Manager/ Team leader |
| Regulators |
|
|
|
legal advisor /HR Manager |
| Shareholders |
|
|
|
CEO/GM |
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