Policy: | Harrington Signal Inc. shall continually improve the suitability, adequacy, and effectiveness of the Quality Management System (QMS). |
Purpose: | To define the methods and responsibilities for analyzing and evaluating results and the outputs from management review to determine needs or opportunities to be addressed as part of continual improvement. |
Scope: | This procedure applies to Harrington Signal Inc.’s QMS. |
Responsibilities: | Department Managers are responsible for ensuring that QMS measurement data is analyzed.
Top Management and Department Managers are responsible for analyzing data using appropriate techniques and reporting measurement data at periodic Management Reviews. Department Managers are responsible for producing and using process monitoring and measuring data for the purpose of continually improving Harrington Signal Inc.’s QMS. |
Definitions: | Pareto diagrams – Histogram chart method that ranks data high to low to separate the vital few from the trivial many. Also known as the 80/20 rule.
Trend or run charts – chart method that plots process output over time.
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Procedure: |
1.0 Data collection
The following data (and others, as required) are gathered by the appropriate department managers or process owners:
- Customer satisfaction (see QP1190 CUSTOMER SATISFACTION);
- Product quality data demonstrating conformity to requirements and/or identifying nonconformities (see QP1180 MONITORING-MEASUREMENT); and
- External provider performance (see QP1120 EXTERNAL PROVIDER EVALUATION).
- Process Performance Data
2.0 DATA ANALYSIS
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- Top Management shall ensure data is analyzed using appropriate techniques (e.g., pareto diagrams, trend or run charts, control charts, word documents) to highlight performance trends, effects of process improvement projects, and product or process nonconformities.
- Top Management shall summarize, visually represent (e.g., charts, graphs, maps, word documents), and report on information collected regarding product variability and its effect on product quality.
- Top Management shall identify and analyze special cause variations (nonconformities) and use quality tools to discover their root causes. Identifying and correcting root causes are key activities in continual improvement.
3.0 Continual Improvement
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- Top Management shall review the results of quality data analyses as needed, or at periodic Management Review meetings, in accordance with QP1060 MANAGEMENT REVIEWS.
- Top Management shall consider the results of data analysis, as well as results of Internal Audits and corrective and preventive actions, against the Quality Policy and Quality Objectives in order to determine – and, if necessary, act on – opportunities to improve the effectiveness of the Quality Management System.
- When opportunities are identified, Top Management may form a Quality Improvement Team to investigate, analyze, and report its findings and offer recommendations for improvement, in accordance with QP1040 NONCONFORMITY AND CORRECTIVE ACTION.
- Top Management or Department Manager shall review the Quality Improvement Team’s reports, presentations, and recommendations. Based on the analysis – and on cost, risk, projected return, and possibly other factors – Top Management may approve, decline, or defer recommended actions, based on business priorities, available resources, and the need for additional information.
- If Top Management or Department Manager approves the recommended actions, it shall ascertain and possibly reassign priorities and provide the resources needed to take action. If Management declines or defers, it shall state its reasons and request the Team:
Decline | Take no further action. |
Defer | Revise and resubmit OR suspend activity until further notice. |
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- The effectiveness of actions taken shall be monitored and reported on by the Quality Manager along with other Department Managers at future Management Review meetings, in accordance with QP1060 MANAGEMENT REVIEWS.
- Effectiveness Criteria:
- Reduced process variability
- Improved process capability
- Reduced frequency and severity of nonconformities
Revision History:
Revision | Date | Description of Changes | Approved By |
0.0 | 07/03/17 | Initial Release | Jim Theesfeld |
1.0 | 8/17/18 | Digitized version | Todd Gifford |