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5.4 Planning 5.4.1 Quality Objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within MII. The quality objectives shall be measurable and consistent with the quality policy. These are established and reviewed at Management Review meetings (Process 4.1). 5.4.1.1 Overall Measures · On Time Delivers – Quarterly – Percentage · Rejections from the Customer – Quarterly – PPM 5.4.1.2 Manufacturing Support Measures · Variance Report – Monthly Variance of planned standards to actual costs per part number Material Costs Plan – Purchasing Actual – Purchasing Labor Costs Plan – Technical Manager Actual – Manufacturing Scrap Plan – Technical Manager Actual – Manufacturing Subcontract Plan – Purchasing Actual – Purchasing This measure takes into consideration the entire management, office stage, and manufacturing group. Measure will be the number of occurrences that exceed a dollar amount or a percentage limit set by management at management reviews. · Audit Findings – Occurrences 5.4.1.3 Manufacturing · Internal Rejections – Quarterly – Occurrences (PPM) · Audit Findings – Quarterly – Occurrences · Scrap – Quarterly – Percentage 5.4.2 Quality Management System
Planning Top management
shall ensure that: a. the planning of the
quality management system is carried out in order to meet the requirements
given in 4.1, as well as the quality objectives, and b. the integrity of the
quality management system is maintained when changes to the quality management
system are planned and implemented. Quality Management Planning
takes place at annual management review meetings (Management Review Procedure
P4.1). 5.5 Responsibility, Authority and Communication: 5.5.1 Responsibility and
Authority: Top management shall ensure that the responsibilities and authorities
are defined and communicated within MII.
See Training
Records For Job Descriptions 5.5.2 Management Representative Top management shall appoint a member of management who, irrespective of
other responsibilities, shall have responsibility and authority that includes: a. ensuring that processes
needed for the quality management system are established, implemented and
maintained (see Process Flow Chart and Internal Audits 8.2.2), b. reporting to top
management on the performance of the quality management system and any need for
improvement (see Management Review 5.6), c. ensuring the promotion
of awareness of customer requirements throughout MII (see Human Resources 6.2),
and d. the organizational freedom to resolve
matters pertaining to quality. The Quality Manager has been appointed as the Quality Management
Representative. 5.5.3 Internal Communication Top management shall ensure that appropriate communication processes are
established within MII and that communication takes place regarding the
effectiveness of the quality management system. The primary means of communication of the quality management system is
through the use of meetings such as department meetings with employees. MII utilizes an open door policy to
associates for communication of concerns and improvement to the quality
management system. Quality display
boards are also utilized to post performance measurements to show the
effectiveness of the quality management system. 5.6 Management Review 5.6.1 General Top management reviews MII' quality management system, on annual basis,
minimum, to ensure its continuing suitability, adequacy and effectiveness (see
Management Review Procedure P4.1). The review includes assessing opportunities
for improvement and the need for changes to the quality management system,
including the quality policy and quality objectives. Records from
management reviews are maintained (see 4.2.4). 5.6.2 Review Input The input to
management review shall include information on: a. results of audits, b. annual customer
feedback and customer satisfaction measurements, c. process performance and
product conformity, d. status of preventive
and corrective actions, e. follow-up actions from
previous management reviews, f.
changes that could affect the quality management system, g.
recommendations for improvement, and h.
resources by department. 5.6.3 Review Output The output from the management reviews include any decisions and actions related to: a. improvement(s) of the
effectiveness of the quality management system and its processes, b. improvement(s) of
product related to customer requirements, and c. resource needs. |
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