ISO 9001 Training
Understanding ISO 9001:2008
Delicious
Digg
Reddit
Stumbleupon
Ma.gnolia
Facebook
Newsvine
BlinkList
Spurl
ISO 9001 TrainingUnderstanding ISO 9001:2008
|
|
7 Product Realization 7.3 Design and Development 7.3.1 Design and Development Planning The organization shall plan and control the design and development of product. During the design and development planning, the organization shall determine: a) the design and development stages, b) the review, verification and validation that are appropriate to each design and development stage, and c) the responsibilities and authorities for design and development. The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. Planning output shall be updated, as appropriate, as the design and development progresses. NOTE: Design and development review, verification and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as suitable for the product and the organization. |
ISO 9001 Training - Key Explanation Points and
Tips:
You must
include product design and development in your QMS scope if you contract or convey the perception that you design
product, regardless whether you buy, outsource or actually do design and development.
The scope of
your d & d activity must consider all aspects of the product and product realization processes to ensure its
conformity to requirements. This includes product identification, handling, packaging, storage and protection
during internal processing and delivery to the customer.
Product d &
d sometimes results in new manufacturing processes or changes to existing manufacturing processes. This clause is
equally applicable for designing and developing manufacturing
processes.
Product design and development planning
must focus on error prevention rather than detection in product quality as well as product realization
processes.
You must have an overall plan for your
design project. Your plan must specify the design and development stages, activities and tasks;
responsibilities; timeline and resources; specific tests, validations, and reviews; and outcomes. There are
many tools available for planning ranging from a simple checklist to complex
software.
The degree and details of planning may
vary according to size and length of contract or project, complexity, risk, product life, customer and
regulatory requirements, past experience with similar product, etc. You have flexibility in determining the
scope of the stages, review, verification and validation required for your product d & d
projects.
Your plan must be dynamic and updated
as requirements and circumstances change. You must track progress against your plan at regular intervals or
project milestones and update the plan as activity progresses.
Your d & d plan must include methods to communicate information, responsibilities,
results, discussions, reviews and resources.
You must take a multi-disciplinary approach that includes as needed, other functions
(besides design) such as quality, engineering, purchasing, sales, tooling, production, etc. Your plan must
clearly identify these other functions and their specific role and responsibilities regarding the project.
Consider including customer and supplier personnel at appropriate stages to do work and review results or
progress.
The d & d project plan serves as both a document and a record as it is updated for completion for various activities.
Where some or all of clause 7.3 d & d activities are done offsite, then you must show the linkages and interaction of these offsite activities with your on-site QMS processes (see clause 4.1).
Clause 7.3 does not require a ‘documented’ procedure. However, you must identify and document all processes addressing this clause as part of your QMS (see clause 4.1). For these processes, you must also identify what specific documents are needed for effective planning, operation and control of production activities (see clause 4.2.1d).
These documents may include - contracts; technical drawings and specifications; a documented plan for d & d; work instructions; a 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 (also see clause 4.2.1 notes). Many organizations use various software tools to document their product or process d & d plans.
If the nature of your business does not require you to design and develop product (e.g. you manufacture strictly from customer provided engineering drawings and specifications), then you must clearly state this exclusion to your QMS scope, in your quality manual.
Performance indicators (to measure the effectiveness of design and development processes in meeting requirements and achieving quality objectives) should focus on reducing variation in and improving these processes and related use of resources. Indicators may include reduction in - design cycle time; development cycle time; specification errors, omissions; changes; d & d costs; etc., as well as measurable improvements in products developed.