CHAPTER 5
Process Focus
ANSWERS TO INSTRUCTOR RESERVE MATERIALS
Instructor Reserve materials are older Quality in Practice features and Cases from previous editions that may be used by
the instructor to give the students additional experiences. These are available in the Instructor materials in a separate
folder.
Case- Stuart Injection Molding Company
To meet ISO 9000 certification requirements, as well as QS-9000 requirements as an
automotive supplier, Stuart will have to develop a comprehensive quality manual. Based on
broad ISO 9000 categories, the following might be an outline of the content of a quality
policy and procedures manual:
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
5 Management responsibility
6 Resource management
7 Product realization
7.1 Planning of realization processes
7.2 Customer-related processes
7.3 Design and/or development
8 Measurement, analysis and improvement
8.1 Planning
8.2 Measurement and monitoring
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.3 Measurement and monitoring of processes
8.2.4 Measurement and monitoring of product
8.3 Control of nonconformity
8.4 Analysis of data
8.5 Improvement
1. The Plant Manager (PM) is responsible for ensuring the success of the quality management
system by providing the necessary resources and reviewing system performance. There
should be statements in the manual concerning: Management commitment, customer focus,
management’s part in developing the quality policy, quality planning administration, and
management review of results.
2. There was no discussion of ISO category 6, Resource items. More information would be
needed on human resources and physical resources, as it relates to the quality system,
including: Provision of resources, human resources, facilities, and work environment.
3. A number of sub categories are included under ISO category 7, Product Realization.
Under 7.2 Customer-related processes – Identification of customer requirements, review of
product requirements, customer communication processes may be carried out by the
Marketing and Sales department when they conduct market research to understand customer
needs and handle customer complaints.
Under 7.4 Purchasing – was not specifically mentioned in the discussion held with SIMC
employees. However, the manual must cover aspects of: Purchasing control, purchasing
information, verification of purchased products.
4. Category 8, Measurement, analysis, and improvement, also includes numerous sub-
categories that would have to be included in the manual. Generally, these appear to be well
covered by SIMC’s current practices. However, processes and procedures would have to be
documented for inclusion in the manual.
Under 8.1, Planning – activities required to design and maintain the measurement and
analysis systems. (assumed to be performed by the Q.A. Department and cross-functional
teams, depending on the system. More information needed.)
Under 8.2 Measurement and monitoring – of customer satisfaction (Marketing and Sales
department), internal audit (Q.A. department), measurement and monitoring of processes
(Manufacturing and Q.A. departments) and measurement and monitoring of product
(Manufacturing and Q.A. departments).