7.1.4 Change Control7.1.4 Change ControlHave a process to
control & react to changes from internal, customer or supplier
sources, that impact product realization. Your controls
shall:Assess the changes and their effects.Define verification and
validation activities (for these changes) to ensure compliance with
customer requirements.Validate changes before implementation.Review
with your customer, any changes to propriety designs, impact on
fit, form and function, to ensure that all effects are
evaluatedPerform any additional verification/ identification, when
required by the customer, e.g. new product introductionNote 1 :
Notify & get approval from your customer, for any product
realization change affecting customer requirements.Note 2 : This
clause for change control applies to changes to product as well as
manufacturing processes.Key Explanation Points and Tips: Clause 7.1
is essentially a repeat of clause 4.1, but applied specifically to
product realization processes (see clause 4.1 explanation points
COPs). The focus is on controls governing the making of product to
meet customer requirements and all the QMS processes that, directly
or indirectly, make this happen. Review specific product
realization requirements at OEM customer or IATF websites. Product
realization processes may include customer related processes (sales
and marketing); design and development; production; shipping;
receiving; packaging; measurement and monitoring of product and
processes, customer satisfaction feedback; etc., whether performed
onsite or off-site. Some of the support processes that apply to
product realization processes include - document control; record
control; human resources; infrastructure provision and maintenance;
IT; purchasing and materials management; laboratory services; and
control of monitoring and measuring devices, etc. You must show the
sequence and interaction of these processes. The APQP is an
excellent tool to accomplish this. Using the APQP methodology, your
organization can identify the processes and controls needed to plan
product realization from identification and understanding of
customer requirements; product design and development if
applicable; manufacturing design and development; manufacturing and
delivery. The focus of APQP is defect prevention and continual
improvement, as well show how the processes link and interact with
one another. The notes to 7.1 also permit you to use other project
management tools or clause 7.3 requirements to develop product
realization processes. You may need to consult your customer to
confirm such alternate methods. The Quality Plan (Control Plan) is
the output of the APQP process and is used to deploy product
realization. The Control Plan must include product details and
control characteristics; process sequence and process control
parameters; specific resources needed to make, verify and deliver
product; product and process monitoring and measurement controls;
plans to control and correct any product or process
nonconformities. reference to support processes; documents needed
(such as work instructions or engineering specifications, etc.) and
details of records to be kept; Focus on defect prevention in
planning the controls for product realization Quality objectives;
product requirements as well as product realization process
requirements may come from the customer, your own organization,
regulatory bodies and industry standards or codes. Quality
objectives may include defect rates; PPMs; scrap rates, etc.
Requirements or criteria for the product may include physical;
dimensional; functional, etc, and their related measurements,
tolerances and acceptance levels. In many instances, depending on
the nature of the product, the customer may specify objectives and
requirements /criteria for the product realization processes as
well. Obtain customer clarification and approval where required.
Many customer requirements may come from the sources and reference
documents I listed on page 1 of this document. You must pay careful
attention to this listing as they may be as applicable as customer
contracts and product specifications. Required verification,
validation, monitoring, inspection and test activities must apply
to all processes identified for product realization and must be
defined in your FMEAs, Control Plan, work instructions, and other
documents used for product realization. Access to storage of
confidential documents and data (electronic or hard copy) should be
controlled. Be extra careful of confidentiality requirements
relating to new projects and changes. Obtain clarification and
approval from your customer when outsourcing production or needing
to disclose technical information when sourcing materials. Change
control is a very important part of the product realization
process. It applies to ANY change in product realization and
includes product and manufacturing process changes. Uncontrolled
changes lead to both customer and internal quality problems. The
defined process must include authority for change and consistency
of implementation and communication. For effective change control,
follow the applicable requirements of the APQP methodology for
assessing, verifying and validating product realization changes
before implementing. Comply with any customer requirements for
notification and approval of changes. Your change control process
must include responsibility; evaluation; verification and
validation; frequency; timing; method; communication; training;
documentation; update of affected activities and documents;
implementation; use of multi-disciplinary approach; checklists;
etc., for product realization changes. Changes may arise from
customer complaints; feedback from the field; new technology;
supplier and material changes; internal or customer driven changes;
process improvements; SPC data; etc. Product realization changes
may affect several linked activities and documents. Such as clauses
(4.2.3.1; 7.3.6.3; 7.3.2.3; 7.3.3.1; 7.3.3.2; 7.3.6.2; 7.5.1.1 and
7.5.1.2). These cover customer engineering specifications; FMEAs
(design and process); Control Plans; design record; inspection
instructions; machine process parameters; material specifications;
measuring equipment; part approval requirements; technical
drawings; and work instructions. Where any of the product
realization processes are done 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 TS 16949 requirements. Evidence of
the off-site facilitys compliance may include - a copy of their TS
16949 certification; results of their internal audits to TS 16949;
auditing the outsourced facility; etc. The expectation is to flow
down to the off-site facility, the relevant TS 16949 requirements
that you would have to implement, had you carried out the process
at your own facility. Performance indicators, (to measure the
effectiveness of product realization in meeting requirements and
achieving quality objectives,) will be specific to each realization
process and focus on reducing variation and waste in realization
processes and related use of resources. Objectives may be used to
monitor and improve process productivity; reduction of cycle time,
errors, omissions and failures; etc. You must also consider
indicators to measure product performance such as - reduction in
defect rates, PPMs (defective parts per million), scrap rates,
waste and rework; improvement in on time delivery (see clause
7.1a); product returns from customer; etc.