efficient quality management

The Quality Manager is responsible for the administration of the Quality Plan and has the authority to manage all work affecting quality. The Quality Manager will provide leadership for the development, implementation, communication and maintenance of quality systems policies and procedures for the Company according to the approved quality system. A primary goal is to achieve a high degree of joint ownership of quality and compliance strategies with all of the major operational stakeholders in the Company while addressing regulatory requirements in an effective, timely and responsible manner.

Responsibilities

• Formulate and manage the development and implementation of goals, objectives, policies, procedures and systems pertaining to the quality assurance and regulatory functions.

• Develop, implement, communicate and maintain a quality plan to bring the Company’s Quality Systems and Policies into compliance with quality system requirements.

• Manage documentation related to Quality System guidelines.

• Quality Assurance project lead for cross-functional projects including determining QA timelines, plans and position strategies.

• Manage and maintain the quality aspects of the Design Control Program including but not limited to design input and output documentation, applicable risk analyses, verification and validation activities and formal design reviews.

• Provide leadership for developing and directing Quality Assurance and Quality improvement initiatives (Cost-of-Quality reductions, Audit system, CAPA system, etc.) for all products, processes and services.

• Manage and maintain the Company’s internal quality audit program and assess improvement initiatives resulting from all Quality Audits – internal and external.

• Effectively interact with Production and Development teams to maintain product supply and help introduce new products.

• Manage training of all company personnel in the requirements, documentation and maintenance of the corporate Quality System.

• Manage and maintain the Company’s quality inspection and product release programs for incoming and in-process materials and components, processes and finished goods.

• Establish an auditing program and lead compliance audits of third party suppliers, manufacturers and distributors.

• Report on timely basis to executive management on the performance of the quality system, any non-compliance issues and recommended actions.

Qualifications

• Minimum of 5 years of Quality Systems supervisory/management experience within a related industry.

• Experience interacting with regulatory authorities.

• Experience in quality management systems.

• Experience in quality system audits.

• Working knowledge of design control processes.

• Experience with statistical sampling plans and trending analyses.

• Knowledgeable about electronic data management.

• Professional certifications (e.g. American Society for Quality (ASQ), Certified Quality Auditor (CQA) desirable).

Skills

• Ability to lead projects and programs with a positive “Get It Done” attitude.

• Organized, attentive to detail and able to prioritize and handle multiple projects with competing deadlines.

• Works efficiently both on independent basis and as part of a team.

• Ability to deal effectively with all levels within the organization as well as with external parties, including regulatory bodies.

• Proven strong problem solving ability with attention to root cause.

• Maintains a personal and professional “continuous improvement” philosophy.

• Excellent written and verbal communication skills, strong interpersonal skills.

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The quality manager should be familiar with management tools for problem solving, process management and various metrics. Quality managers use problem solving tools to determine root causes and suggest solutions from various perspectives using data to make decisions.

Problem solving tools include:

1. The Seven Quality Tools using Pareto charts, cause and effect diagrams, flowcharts, control charts, check sheets, scatter diagrams and histograms.
2. Basic management and planning tools using Affinity diagrams, tree diagrams, process decision program charts, matrix diagrams, interrelationship digraphs, prioritization matrices and activity network diagrams.
3. Process improvement tools using root cause analysis, PDCA, six sigma DMAIC model, failure mode and effects analysis and statistical process control.
4. Innovation and creativity tools using creative decision making and problem solving techniques that include brainstorming, mind mapping, lateral thinking, critical thinking and design for six sigma.
5. Cost of Quality using prevention, appraisal, internal and external failure costs to suggest ways and means to improve the bottom line.

Process Management Tools include:

1. Planning and setting goals
2. Establishing controls
3. Monitoring and measuring performance
4. Documentation
5. Cycle-time reduction
6. Waste elimination
7. Theory of constraints for local vs system optimization and physical vs policy constraints that affect throughput
8. Elimination of special causes of variation
9. Maintaining improvements
10. Continuous improvement
11. Process mapping
12. Flowcharting
13. 5 S’s
14. Just in time
15. Kanban
16. Value streams

Measurement, Assessment and Metric Tools include:

1. Goal-question-metric modeling to identify when, what and how to measure projects and processes
2. Sampling techniques when appropriate
3. Statistical analysis to measure central tendency, dispersion and types of distributions to monitor processes and make data oriented decisions
4. Trend and pattern analysis to assess data-sets, graphs and charts for various cyclic, seasonal and environment trends and pattern shifts
5. Theory of variation to identify common and special causes of variation
6. Process capability using Cp and Cpk indices
7. Reliability and validity measurement theories using content, construct and criterion types of measures
8. Qualitative assessments using anecdotal feedback, observations and focus group output instead of objective measurements
9. Survey analysis interpretation

Additional quality manager skills include:

1. Customer relationship management to ensure partnerships and alliances
2. Energizing internal Customers to improve products, processes and services
3. Identification and prioritization of Customer needs and expectations using tools such as Voice of the Customer, House of Quality, Quality Function Deployment, focus groups and Customer surveys
4. Measurement of Customer satisfaction and loyalty using complaints, surveys, interviews, warranty data, value analysis and corrective actions
5. Conflicting requirement resolution and management of resources

How-To Achieve the Goal

Cheat – that’s right – cheat; well, another way to put it is to re-design the process to control the sheet music. Remember the movie clip from “Dune” – “He who controls the spice controls the universe”? Well, if you control the sheet music then you control the orchestra. That’s the tail wagging the dog but the technique works. Everybody in the orchestra needs sheet music so all you have to do is implement Efficient QMS™ in your business process to truly orchestrate (manage) an efficient quality management system.

This entry was posted on Sunday, November 16th, 2008 at 9:56 am and is filed under Efficient QMS™. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.