IJCA - Volume I - Flipbook - Page 57
56 The International Journal of Conformity Assessment
information delivery
• Delivery of documents and preservation of
records
(2) Design and Development Input
Inputs related to product requirements must be
determined and records maintained. This should
include the following:
1. Function and performance requirements
2. Applied legal and regulatory requirements
3. Information derived from previous similar
designs, if applicable.
4. Essentials of other requirements for design
and development
The adequacy of these inputs should be reviewed.
Also, the requirements should be complete, clear,
and not conflict with other requirements.
(3) Design and Development Output
The output of the design and development process
shall be provided in a verifiable form compared
to the design and development inputs and shall
be approved prior to distribution. The design and
development output should be as follows:
1. Meet design and development input
requirements
2. Provide appropriate information for purchase,
production, and service provisions.
3. Include or cite criteria for product acceptance
judgment.
4. Determine the characteristics of products that
are essential for safe and right use.
(4) Design and Development Review
At an appropriate stage, a systematic review of
design and development should be conducted for
the following:
1. Evaluation of the ability of design and
development results to meet requirements.
2. Recognition of problems and suggestion of
necessary measures.
The people participating in such reviews should
include those representing functions related to
the design and development stages of the subject
that is under review. Records of the review, and
results of measures caused by the review, should be
maintained (see 4.2.4).
2022 | Volume 1, Issue 1
(5) Design and Development Verification
for machinery or production facilities.
Verification must be performed to guarantee
that design and development output meets input
requirements.
Also, a system for securing product safety
by linking product certification is required. In
particular, this includes system certifications
such as ISO 9001, ISO 13485 (medical devices),
GMP (pharmaceuticals, cosmetics), HACCP
(food, beverage), TL-9000 (telecommunications
equipment), IATF-16949 (automotive), AS-9000
(airplane), etc. and CE mark, UL mark, etc.
Records of verification and all required activity
results should be maintained.
(6) Design and Development Validity
To ensure whether the finished product can meet
the requirements for the prescribed or intended
use or application, validation of the design and
development must be performed in accordance with
the planned method.
If applicable, validation must be completed prior to
delivery or execution of the product.
Records of the validation results and the results of
necessary measures should be maintained.
(7) Management of Design and Development
Changes
Changes in design and development should be
identified and records maintained. If suitable,
verifying changes and their validity should be
approved prior to implementation, if applicable.
The review of design and development changes
involves evaluating changes in components, and
their impacts on delivered products.
Records of reviewing the changes and their results,
as well as any measures, should be maintained.
5. Manufacturing Process Management
(1) Manufacturing Process Management Plan
Regarding product liability prevention measures,
managing the manufacturing process helps to
ensure that safety items considered in design and
development stages can be sufficiently reflected
when manufacturing.
Workers’ workability, normal operation of facilities,
and reliability of inspection equipment are directly
related to defects that may occur during the
manufacturing process, and it is important to
establish and continuously manage standardization
and management measures for them.
Solutions for defects that may occur during the
manufacturing process are as follows:
1) Safety Management Concept Input for Each
Process
It is necessary to establish a management system
2) Resolution of Defects Due to Non-Uniformity of the
Product
Manufacturing defects are problems within the
range that can be avoided by quality management
activities in process management.
On the other hand, design defects, warnings, and
marking defects are essentially different from
manufacturing defects.
3) Resolution of Defects by Strengthening Inspection
Tasks
By using raw materials and parts that have passed
the imported inspection, and strengthening
inspection tasks in the product production
process, the incidence of defects before the final
inspection is minimized.
(2) Product Liability Accident Prevention Measures
at the Manufacturing Stage
Product liability prevention measures at the
manufacturing stage may be affected by several
factors.
Each factor—such as raw materials or parts input
into the process, manufacturing equipment or
machines necessary for product production, and
employees directly participating in production, etc.—
is to be considered at the manufacturing stage, and
also work processes are matters to be considered
Countermeasures for product liability prevention for
each factor are as follows:
1) Raw Materials and Parts
Selection and training of suppliers, reconfirmation
of purchase specifications and import standards,
thorough import inspection, and resolution of
storage management problems.
2) Work Process
Work standardization, thorough process and
quality control, thorough management of safety
check items, clarification of process change
procedures, and development of measures to
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prevent foreign substances from entering.
3) Manufacturing Equipment and Machinery
Total production maintenance activities and
machine abnormalities prevention.
4) Employee Training
Training of new employees, safety training, and
improvement of product liability awareness.
(3) Application of the Quality Control System
Quality control measures applicable to product
liability prevention at the manufacturing stage include
production and service provision management,
validation of production and service provision
processes, identification and traceability, and
product preservation. In cases of production with raw
materials or parts supplied from customers, separate
management of customer assets is required.
1) Management of Production and Service Provision
In production, information that defines the
characteristics of the product to check product
specifications and design considerations and
prepare work instructions to align with that.
Production is carried out using appropriate
equipment according to work instructions and
availability is checked for effectiveness using
reliable measuring devices. It is also necessary to
check validity continuously through the follow-up
management of products that have been released
and delivered to consumers.
2) Confirmation of Validating Production and Service
Provision Processes
To confirm the validation of production and service
provision processes, there must be a set standard
for reviewing and approving the production
process.
There must be approval for production facilities,
and qualifications must be recognized about
employees who conduct inspection tasks, design
and development tasks, etc.
Based on this, production is carried out according
to the prescribed methods and procedures, and
quality records generated during that process
must be managed by setting a storage method,
storage period, etc.
The validity of such a process should be checked
continuously, and if a problem occurs, appropriate
measures should be taken against the applicable
process, personnel, facilities, etc.
