Process Development
The ISO 9001:2000 Standard
Document Control
One of the requirements of the ISO 9001: 2000 standard is that
you have a process to plan for the production of the product or
service that you provide. I will provide you with a sample
section from a quality manual and a sample procedure that
defines a simple process for planning for product realization.
ISO Requirement:
7.1 Planning of product realization
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:
- quality objectives and requirements for the product;
- the need to establish processes, documents, and provide
resources specific to the product;
- required verification, validation, monitoring, inspection
and test activities specific to the product and the criteria for
product acceptance;
- records needed to provide evidence that the realization
processes and resulting product meet requirements (see 4.2.4).
Section from a typical quality manual
7.1 Planning of Product Realization
Acme plans and develops the processes needed for product
realization as defined in procedures. Planning of product
realization is consistent with the other processes of the
quality management system and suitable for the Hawkins method of
operation.
Acme determines the following for product realization:
- product quality objectives and requirements through the
review of customer order requirements
- the necessary processes, documents and resources specific to
the product
- verification, monitoring, inspection and testing activities
specific to the product and the criteria for product acceptance
are defined in procedures, instructions and specifications
- validation will be performed whenever possible
- the records needed to provide evidence that the realization
processes and the resulting product meet defined requirements.
Acme
Manufacturing Company, Inc.
Operating Procedure
Title: Process Development
No. XX
Rev. 0
Page 1 of 1
Approved by:
Date:
SCOPE:
This procedure defines how Acme reviews requests for quotes and
develops
the manufacturing processes and associated documentation used to
produce product.
1.0 RECEIVE
REQUEST FOR QUOTE
Quoting receives the print and/or
specifications along with the request for quote. The information
received is reviewed by Quoting and any other appropriate
personnel to assure that Acme has the capability to deliver what
the customer is requesting.
2.0
CAPABLE ?
No - go to 2.1
Yes - go to 3.0
2.1
NO QUOTE
Quoting notifies the customer that Acme will not quote on the
job as
received.
3.0
QUOTE
Quoting prepares a quote and sends it to the customer
4.0 RECEIVE
AND REVIEW ORDER
The order is received and reviewed by Quoting to assure that the
order
matches the original quote.
5.0
ENTER ORDER
The order is entered into the system which generates a sales
order and a
work order. Order Entry then schedules the order which serves as
the record
of customer order review. Order Entry sends a confirming order
to the
customer.
6.0
PRE-PRODUCTION
The following are created from the print and/or specifications
in preparation
for production.
|
- Program, router and traveler - prepared by Engineering
- Inspection report - prepared by QA
|
7.0
FIRST RUN PRODUCTION
A layout inspection is performed by QA against the
specifications on the
print and recorded on the inspection report. If any changed are
necessary,
QA notifies Engineering.
Neal Stiemert
President
Independent Quality Consultants, Inc.
About the Author
 Neal D. Stiemert is President of Independent Quality Consultants, Inc. and holds a
Bachelor of Science degree from Indiana University school of business. Neal is an ASQ Certified
Quality Engineer, a certified lead auditor and has over 24 years of management, auditing, consulting
and training experience in the quality profession.
Neal has served as an examiner for the Minnesota Quality Award, an SPC instructor at Purdue
University and an officer and committee member in the Chicago and Minnesota sections of ASQ.
Neal also conducts registration audits for Smithers Quality Assessments and SAI Global Assurance
Services.
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