ISO 9001-Clause 7 Product realization
ISO 9001-Clause 7.1 Planning of product realization
ISO 9001 requirement:
The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).
In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes and documents, and to provide resources specific to the product;
c) required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).
The output of this planning shall be in a form suitable for the organization’s method of operations.
NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract can be referred to as a quality plan.
NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.
Clause 7.1 is essentially a repeat of clause 4.1, but applied specifically to product realization processes. 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. 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, etc., whether performed onsite or off-site. Some of the support processes that come to bear on product realization 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, business planning etc. The output of product realization planning may be implemented in many different ways. It does not necessarily have to be all in one document, but may sometimes include several documents such drawings, machine set-up, inspection criteria, process sheets etc. These must be readily available to those performing realization processes.
You may also consider using specific product, contract or project quality plans to accomplish this. Your quality plans should include the processes needed, process sequence and control parameters, specific resources needed to make, verify and deliver product, product acceptance criteria and quality objectives, 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. The notes to 7.1 also permit you to use other project management tools or clause 7.3 product design and development requirements to plan for product realization processes.
Quality objectives may include defect rates, scrap rates, etc. Requirements or criteria for the product may include physical properties, 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 and criteria for the product realization processes as well. 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 processes. These documents may include contracts, specifications, orders, product quality plans, 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. 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 ISO 9001 requirements. 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. 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, PPM’s (defective parts per million), scrap rates, waste and rework, improvement in on time delivery, product returns from customers etc.
- Are the processes needed for product realization planned, developed and documented in a quality plan?
- Are the following determined in the quality plan, as appropriate:
1) Quality objectives for product, project or contract
2) Need to establish processes / documents
3) Need to provide resources / facilities
4) Required verification, validation, monitoring, inspection, test activities & criteria for acceptance
5) Records to provide evidence of conformity to established processes & product requirements?
- Interview those employees responsible for launching new products, services and processes. Get answers to these questions:
1. Is there a plan on how existing products/services will be produced or supplied? Is there a flowchart of the main steps?
2. Is a plan in place for introducing: New products? New services? New contracts? New processes? New projects? New locations? New computer systems?
3. Any examples of these “new” activities in the past 12 months? If so, was a plan followed? Is a checklist used? How was implementation of all the critical steps managed?
4. How is the transition from “new” to “normal operations” managed?
5. How are new processes monitored and measured? How are any new records identified? What is the result/output of any planning activities?
Mandatory Procedure : Not applicable
records needed to provide evidence that the realization processes and resulting product meet requirements. This is bit tricky and can be done in number of ways depending on the type of organization. For eg in manufacturing process it can be done in the following steps
1) Understanding customer requirement- Contract review or order details
2) Converting requirement into plan- Quality plan, Process plan
3) evidence of product meeting requirement-Pre dispatch inspection report
4) evidence of process meeting requirement- inprocess inspection report
|Example of format for Process plan|
|Example of template for Project Quality plan|
|Example of format for Quality plan|
Evidence/Implementation document ( Not mandatory but helps in fulfillment of requirement):
Output of product realization planning: drawings, machine set-up, inspection criteria, process sheets, work instructions or engineering specifications, Objectives may be used to monitor and improve process – productivity, reduction of cycle time, errors, omissions and failures, etc.
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