We have antiquated systems, primarily in our heads and are basically starting from scratch again. What it the most modern system? What is the difference between AS9003 and AS9100? Were your forms created as an ISO system that would make a company ISO Certification Ready? If not, do you have such a system?

The AS9003 QMS is known as “Less than AS9100″ and was very popular but Boeing has deleted it from their Supplier flowdown and replaced it with AS9100. Boeing required their Appendix A Suppliers to get registered by June 2007 and their Appendix B Suppliers to get registered by June 2008. Find Boeing’s Supplier requirements at: http://www.boeing.com/companyoffices/doingbiz/supplier/

The most modern QMS is AS9100 – we hear through the grapevine that AS9003 will be abandoned this year by its sponsor SAE.org.

The Manufacturing Company Kit you mentioned in your email is a commercial-grade kit that does not contain the documents necessary to become certified to ISO 9001. Many of the forms in the kit can be used in an ISO QMS but the manuals and procedures are based upon MIL-Q-9858, which do not comply with ISO 9001:2000. The kit is intended to provide businesses that need a comprehensive management system today but no certification to ISO 9001 and to eventually transition to ISO 9001.
Click on the following link to find a matrix that describes how MIL-I-45208 and MIL-Q-9858 complies with ISO 9001:1994 and how ISO 9001: 1994 complies with ISO 9001:2000.

http://www.quality-control-plan.com/cart/catalogue.php?cat=3#qualitysystemscrossreferencematrix

The QMS for AS9120 contains all the forms for compliance to ISO 9001. All the ASxxxx type standards are based upon ISO 9001 and include additional requirements to comply with the aerospace industry. When you elect to certify your QMS you will receive two certificates – one for ISO 9001 and one for the aerospace standard. The Aerospace Suppliers Association provides certification to their standard through certified registrars but they are not as widely known as the ASxxxx series of standards.

If you are starting your QMS from scratch and you want the most comprehensive system then AS9120 is a good choice; however, it is intended for a Stockist Distributor so you will need to add some manufacturing requirements to the manual. You could easily integrate MIL-I-45208 into the QMS but if you want the most comprehensive QMS you should consider integrating the manufacturing provisions from AS9100. That’s easy to do by purchasing the procedure for manufacturing from our AS9100 Kit. Our AS9100 kit for $397 is located at:

http://as9100.quality-plan.com/index-1.htm

Of course, any aerospace QMS will cause your business culture to go through a paradigm but that is a decision only you can make based upon your business plan. Are you seeking business with the primes, such as Boeing, Lockheed Martin, Northrop, NASA, etc – they all require certification to an aerospace standard but they’ll work with you if you’re a sole-source.

Since we’re an open-book website you can evaluate the impact of complying with an aerospace standard by browsing through the applicable conformance checklist or internal quality audit, such as AS9101 for AS9100 or AS9121 for AS9120 respectively. You will quickly find the decision to become certified is a life-changing event.

We’ve learned from the school-of-hard-knocks that all QMS standards require a business to make their records easy to collect and review. After you’ve implemented a QMS standard, the collection and management of records is the most costly part of compliance to the standard because those records are the only means you have to prove your compliance to the standard. Since you’re starting from scratch, have you considered using your internal network or your website as a tool to interact with your employees and Customers?

We suggest Efficient QMS™ to make all the effective QMS standards into efficient standards. None of the standards or Customers that flowdown the standards care much about how much pain and expense small businesses suffer to meet their requirements. The standards are designed to be effective and the User is supposed to figure-out how to make them efficient. We’ve done that with eQMS – see for yourself at: www.efficient-quality-program.com

Our most comprehensive Distributor Kit for $297 is based upon AS9120 Stockist Distributor, which can be used to achieve registration to AS9120 and ISO 9001 – evaluate the kit at:

http://as9120.quality-plan.com/index-1.htm

A less comprehensive but up-to-date Distributor kit for $197 is based upon ASA-100 Aerospace Suppliers Association – evaluate the kit at:

http://www.quality-control-plan.com/distributor-qualitymanagementsystem-kits.htm#distributorqualitysystemkit

A little more comprehensive and name-brand Distributor AND Manufacturer kit for $247 is based upon ASA-100 and MIL-I-45208 Inspection System – evaluate the kit at:

http://www.quality-control-plan.com/distributor-qualitymanagementsystem-kits.htm#distributorandmanufacturerqualitysystemkit

Hope this information helps your project.

Consultants are savvy sales-people first and knowledgeable resources second and their personalities sometimes clash with their Clients. We did the “Consultant-thing” once and learned there’s good money in the business but living that battle day-after-day was not our cup-of-tea. We found our calling so that’s what we do and we share our experience at no-charge – we’re here to give honest feedback to people trying to get to their next action item in a business process that we thoroughly understand.

We learned the best way to find a Consultant is to search the Registrar logs for businesses in your area. Almost every Registrar likes to brag about their certifications so they display all the businesses that they’ve certified. Those lists are searchable so you can find businesses in your industry in your area that have the certification that you are targeting. Get your list of businesses then call them to see how they achieved their goal – everyone we’ve spoken with likes to brag about their achievement so they’re a good resource.

We provide the tools that are needed to get the job done without a Consultant – no matter what the task – you’ve got to do the work. You’ll spend more than $20,000 for a Consultant to help you achieve certification to an industry standard. You’re going to spend that much anyway in a short time via group-hugs and orientation meetings. No matter what, you’re going to need a subject-matter-expert. We suggest you spend 10% of the Consultant fee on certification of one of your employees to become an ISO or aerospace auditor, then you’ll have your expert to guide the transition process. Of course, you don’t need a certified auditor to make an expert on the subject. Since you already have to do the work then anyone can educate themselves about the project – click here to see our Auditor training slides and orientation slides to become educated.

People with a master degree or PhD always start from a place called “I don’t know” and learn to achieve their degree. There are no mysteries if you’re willing to do the work – everybody in the business has to do their share of the work to achieve certification.

Hope this information helps your project.

Expenses for ISO 9001 Registration

These expenses change from year-to-year and are influenced by the costs for travel.

Goal and Objectives of Changes to AS9100:2009

• Emphasis on product and process improvement (e.g. risk management, critical items, project management)
• Expand the AS9100 scope to include Aviation, Space & Defense
• Provide additional focus on objective of on-time and on-quality deliveries
• Ensure AS9100 standard is compatible for use by all stakeholder segments and by organizations of all types and sizes
• Ensure AS9100 stays recognized by authorities
• Ensure extensive stakeholder involvement in revision effort by the use of a project management approach to solicit input and manage the revision.

Summary of Significant Changes

• 7.1.1 Project Management
New requirement for planning and managing product realization in a structured and controlled way.

• 7.1.2 Risk Management
New requirement of implementation of a risk management process applicable to the projects & products; responsibility, criteria, mitigation & acceptance.

• 7.1.3 Configuration Management
Moved from clause 4.3 to clause 7.1 and added details on the different activities to be covered.

• 7.1.4 Control of Work Transfer
Moved from clause 7.5 (Production) to clause 7.1 to add emphasis on having a process for planning and control of transfer activities.

• Product quality and on-time delivery performance
Added requirement to measure "product conformity" and "on-time delivery" and take appropriate actions if planned results are not achieved. The intent is to provide a linkage between the QMS and organization performance.

• Process to be required to address control of Special Requirements, Critical
Items and Key Characteristics
Key characteristic requirements remain unaltered but a new concept is added to identify special requirements from the Customer or internal sources that require additional controls (e.g. risk management) that translates into Critical Items that may flow to Key characteristics for variation control.

• Formal monitoring of Customer satisfaction data
Added the requirement to monitor data and to develop improvement plans that address deficiencies. The intent is to promote continuous improvement of the product and Customer satisfaction.

• Requirements from regulatory authorities.
A general requirement has been introduced in 4.1 to address all the applicable statutory and regulatory QMS requirements in the organization’s QMS instead of keeping detailed requirements in chapters.

• First Article Inspection (FAI) moved to clause 7.5.1.1 and renamed.
Production process verification "FAI" is the requirement to validate the production process’s documentation and tooling and repeat the process when necessary (i.e. when engineering or manufacturing processes change). The requirement was moved from 8.2.4.2 (measurement) to 7.5.1.1 (production) because it is part of product realization and is not intended to be a follow-on activity.

• Difference between Key Characteristics, Special Requirements and Critical Items.
Special Requirements are those requirements that have high risks to being achieved, which require their inclusion in the risk management process.
Critical Items, including key characteristics, are those items that have significant effect on product realization and use of the product, which require specific actions to assure they are adequately managed.

• ISO 10007 is referenced after Configuration Management.
ISO 10007 is included in a Note for reference only.

• ISO 9001 changes affect AS9100:2009.
The AS9100 standard has been updated to stay consistent with ISO 9001, which will continue to be the baseline. The changes being incorporated into ISO 9001 are considered an amendment and minor in nature.

• Length of time to transition to AS9100:2009.
30 months. Companies will be encouraged to upgrade on their scheduled audit cycle.

• New "Scope" statement suggests alternate registrations. If an organization applies multiple standards in addition to AS9100 such as AS9110 (Maintenance) or AS9120 (Distributor) then the registration requirements should be determined by
Customer and regulatory requirements. More than one standard registration may be necessary if the Company provides other industry-standard products and services according to its scope of business activities (i.e. a Company that manufactures
products and also sells maintenance services). Clause 1.2 Introduction outlines the new applicability statements for AS9100, AS9110 and AS9120.

• Deleted text from Clause 4.2.2 Quality Manual Relationships.
The deletion of the requirement to create a document showing the relationship between AS9100 requirements and the organization’s documented procedures was seen as adding no value to assuring product quality above the existing ISO text. Users of AS9100 will still need to identify appropriate documented procedures as an inherent part of carrying out an audit.

AS9100 Revision "C" Key Changes
• 6 Additions
• 8 Revisions/Relocations
• 3 Deletions

Detailed Description of Changes in AS9100C

Clause 1 – AS9100 Scope and Application
• Revision: Scope extended to include Defense as well as Aviation and Space.
Application guidance provided when AS9100, AS9110 and AS9120 are appropriate for use.
AS9101 will incorporate AS9111 and AS9121 audit requirements.
• Reason:
The AS9100 QMS is applicable to other complex quality management systems and would receive benefit from implementation including land and sea applications.
Possible additional recognition and synergies with NATO Allied Quality Assurance Publications (AQAPs).
• Considerations:
Increased use and improved understanding of when the various aviation, space and defense standards are applicable.

Clause 3.1 – Risk
• Addition: Define new term "risk"
An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence.
• Reason:
The understanding of risk is important for an organization to develop a proactive quality management system.
• Considerations:
Understanding this term is important to implement a risk management process in the applicable clauses.

Clause 3.2 – Special Requirements
• Addition: Define new term "special requirements"
Those requirements that have high risks to being achieved thus requiring their inclusion in the risk management process.
Factors used to determine special requirements include:
- past experience
- product or process complexity
- product or process maturity.
Examples include:
- performance requirements imposed by the Customer that are at the limit of the industry’s capabilities
- requirements determined by the organization to be at the limit of its technical or process capabilities
• Reason:
Improve understanding of "Special Requirements" and the potential chain of flow to "Critical Items" and to "Key Characteristics."
Ensure these important requirements are systematically addressed and linked to risk management activities by the organization.
• Considerations:
Understanding this term is important to implement special requirement processes in the applicable clauses.

Clause 3.3 – Critical Items
• Addition: Define new term "critical item"
Those items having significant effect on the product realization and use of the product (e.g. functions, parts, software, characteristics, processes); including safety performance, form, fit, function, producibility, service life, etc. that require specific actions to ensure they are adequately managed.
Examples of critical items include:
- fracture critical items
- key characteristics
- mission critical items
- safety critical items
• Reason:
Improve understanding of "Critical Items" coming from Special Requirements.
Ensure these items are systematically addressed and linked to risk management activities by the organization.
• Considerations:
Understanding this term is important to implement critical item(s) processes in the applicable clauses.

INTERRELATIONSHIP BETWEEN SPECIAL REQUIREMENTS, CRITICAL ITEMS, KEY CHARACTERISTICS AND RISK MANAGEMENT PROCESS

Clause 4.1 – QMS General Requirements
• Revision/Relocation: The organization’s QMS shall address Customer and applicable statutory and regulatory QMS requirements (previously located in the QMS documentation 4.2.1).
• Reason:
Clarify that the requirement is placed at the QMS level and not only at the documentation level.
• Considerations:
The concept of "basic QMS" may be used (processes applicable to all Customers / activities) but the documents such as Quality Management Plans that address specific Customers requirements shall be considered as part of the QMS.

Clause 4.2.2 – Quality Manual Relationships
• Deletion: Requirement to create a document showing the relationship between
AS9100 requirements and the organizations documented procedures.
• Reason:
Requirement adds no value to assuring product quality.
Requirement was viewed as prescriptive in that it specifies a particular method of assuring the requirements of the standard have been met.
• Considerations:
Auditors need to identify appropriate documented procedures as an inherent part of carrying out the audit.

Clauses 5.2/8.2.1 – Customer Focus/Satisfaction
• Addition: Top management shall ensure that product conformity and on-time delivery performance are measured and that appropriate action is taken if planned results are not or will not be achieved. (5.2)
Information to be monitored and used for the evaluation of Customer satisfaction shall include but is not limited to:
- corrective action requests.
- Customer complaints
- on-time delivery performance
- product conformity
Organizations shall develop and implement plans for improvement of Customer satisfaction that addresses deficiencies identified by these evaluations and assess the effectiveness of the results.
(8.2.1)
• Reason:
Establish clear relationship between the QMS and organizational performance in line with AS9100 strategy.
To promote continuous improvement of Customer satisfaction.
• Considerations:
Review of management focus and organizational process to measure Customer satisfaction and plan improvements.

7.1.1 – Project Management
• Addition: New requirement for planning and managing product realization in a structured and controlled way to meet requirements at acceptable risk within resource and schedule constraints.
• Reason:
Most aviation space and defense products are complex and involve multi-tier partners and suppliers.
This clause provides additional focus on upfront planning and the management of project plans throughout product realization.
• Considerations:
The organization must have a process to manage product realization planning to ensure quality and schedules are not compromised.
Project plans should be used to manage the successful completion of projects.

7.1.2 – Risk Management
• Addition: New requirement to implement a risk management process applicable to the product and organization covering: responsibility, criteria, mitigation and acceptance. The concept of risk is integrated within the revised AS9100.
• Reason:
Risk Management was placed in clause 7.1.2 to provide additional focus on product risk during product realization.
• Considerations:
The organization must have a risk management process that addresses all of the applicable requirements, such as verification of chemical/physical test reports.
The definition of risk must be appropriately understood and applied in that process.
Risks must be successfully managed in the organization.

7.1.3 – Configuration Management
• Revision/Relocation: Moved from Clause 4.3 to 7.1.3.
Structured in line with ISO 10007 requirements.
• Reason:
Focuses configuration management on the product and how it is sustained throughout product realization.
• Considerations:
Some level of configuration management is expected for all products at all levels of the supply chain in compliance with exclusion criteria (see clause
1.2).

7.1.4 – Work Transfer
• Revision/Relocation: Moved from clause 7.5.1.4 (Production) to clause 7.1.4.
The organization must have a process to plan and control the transfer activities.
Expanded to cover permanent transfer (e.g. from one organization to another, from one organization to supplier, from one supplier to another).
• Reason:
Work transfer can occur at anytime during product realization.
Addresses problems that often occur during work transfers .
• Considerations:
A process must exist to control the transfer of work including planning and subsequent control of the transfer.

Clause 7.4.1 – Recognition of Supplier Quality Data
• Revision: Added note to recognize that one factor that may be used during supplier selection and evaluation is "objective and reliable data from external sources".
• Reason:
Recognition that the industry trend is to use externally provided supplier performance data (e.g. Online Aerospace Supplier Information System – OASIS, Nadcap)
• Considerations:
Note only

Clause 7.4.1 – Approval status for suppliers
• Revision: Added and provided examples of "approval status" (e.g. approved, conditional, disapproved) and examples of "scope of approval" (e.g. product type, process family).
The organization must define the process for supplier approval status decisions or changes.
• Reason:
Clarify that the conditions for using a supplier depends on its approval status.
• Considerations:
The process responsibilities and authority must be defined for this process.

Clause 7.4.3 – Validation of Test Reports
• Deletion: Where the organization utilizes test reports to verify purchased product, the data in those reports shall be acceptable per applicable specifications. The organization shall periodically validate test reports for raw material.
• Reason:
Misunderstood concept that was frequently misapplied.
Requirement was prescriptive, not applicable to all stakeholders (especially small organizations) and for all types of products and was subject to varying interpretation.
• Considerations:
The organization must verify test reports as part of the risk management process if it is making critical items where the material chemical/physical requirements are important.

Clause 7.5.1.1 – Production Process Verification
• Revision/Relocation: Moved from 8.2.4.2 (measurement) to 7.5.1.1 (production)
Requirement to verify production process documentation and tooling are capable of producing parts and assemblies that meet requirements. This process shall be repeated when changes occur that invalidate the original results (e.g. engineering or manufacturing process changes, tooling changes).
• Reason:
Movement to clause 7 acknowledges that this requirement (previously called first article inspection – FAI) is not primarily a measuring and monitoring process but a process that will be used to assure product realization capability under controlled conditions.
Allows justifiable exclusion for unique and individual products.
• Considerations:
Validation of requests for exclusion (unique and individual products vs. production run).

Clause 8.2.2 – Detailed Tools and Techniques
• Deletion: "Detailed tools and techniques shall be developed such as check sheets, process flowcharts or any similar method to support audit of the quality management system requirements. The acceptability of the selected tools will be
measured against the effectiveness of the internal audit process and overall organization performance."
• Reason:
Requirement was too prescriptive – reference to specific tools in a "such as" statement is more appropriate as guidance material.
• Considerations:
Methods and effectiveness measures remain intact in the ISO text. Tools and techniques may still be needed to support the audit process.

Clause 8.2.4 –Sampling Inspection
• Revision: When the organization uses sampling inspection as a means of product acceptance, the sampling plan shall be justified on the basis of recognized statistical principles and appropriateness for use (i.e. matching the sampling plan to the criticality of the product and to the process capability).
• Reason:
Numerous requests were received to improve clause 8.2.4. The comments ranged from it was statistically inaccurate to comments that it was too prescriptive.
• Considerations:
Validation of recognized statistical principles utilized.
Process used to determine criticality of product.

Allowable time for Recertification
Maximum 30 month Implementation from Publication date (January 2009).

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]]> http://www.as9100-quality-system.com/blog/?feed=rss2&p=15 0 http://www.as9100-quality-system.com/blog/?p=7 http://www.as9100-quality-system.com/blog/?p=7#comments Fri, 22 May 2009 19:38:07 +0000 admin http://www.as9100-quality-system.com/blog/?p=7 I know that an effective quality program pays for itself over time and is an accepted expense for operating a business. I know this expense is considered “overhead” or the “cost-of-doing-business” and is usually the first to be cut when right-sizing. The last 10 years of quality evolution has shown me that Customers want professional-grade management in their Suppliers before they’ll consider them as candidates. Today, that means Suppliers must provide a pedigree that proves they are worthy of consideration by concerned Customers.

Customers and Suppliers have only one chance to do it right the first time. They have to invest their time and resources on good practices that will increase profits and continuously win new business from their Consumers. Customers and Suppliers have the same goal – perform as a team to satisfy their Consumers and increase profit margins.

My name is Frank and I’m a career quality manager from a diverse range of sensor and electrical hardware manufacturing for more than 30 years. I’m an employee like any other that desires respect and admiration by my employer. I think I earn that by doing more than expected all the time.

Early in my career I learned to live in 5-year intervals; that is, do it right the first time so it doesn’t need to be improved for at least 5 years. A silly notion, but everybody needs a goal, and after more than 30 years there are so many overlapping 5-year intervals that they’re all a blur.
I still live by the 5-year goal and I’m constantly being inspired by current events or something in history that could improve my job. I found the internet in 1989 and during the 90’s I witnessed the transfer of quality management knowledge to the internet. I joined the evolution in 1998 by releasing all my paper-based knowledge to the internet through www.quality-control-plan.com.

Over the years I’ve lived a lot of “the-flavor-of-the-month” improvement scenarios and I’ve read a lot of twisted guidance by so-called experts in quality management. One endearing book that has stuck with me is Zapp! The Lightning of Empowerment: How to Improve Productivity, Quality, and Employee Satisfaction by William Byham PhD and Jeff Cox (Author). You can find it on Amazon for about $12.00. When you read the book you’ll learn about dinosaur eggs that are laid by the inherent inefficiencies of any process that later hatch to eat your hard work to cause you to do it all over again.

Well, believe me when I say I have scars from the many dinosaurs that have chewed on me where it hurts the most. Such unforeseen grief that hatches when you least need it – just like being crushed by one of Murphy’s Laws.

One of those dinosaurs finally convinced me there must be a better way. One day I was psychologically slapped into submission by a resident Customer during one of their product release inspections. I knew that a few days ago I had a piece of paper that proved compliance to one of their critical requirements but somehow it got misplaced during filing. I threw a bunch of people at the problem but we couldn’t find it so I had to hold the shipment because it would never get past their receiving department if they didn’t have one 8″ by 11″ piece of paper. At that moment of despair I resolved to fix the problem – 99% perspiration and 1% inspiration – I resolved to scan every important document to PDF and store it on the server. Well, that fixed the problem but it created a few new problems and that got me to thinking about other electronic resources that could eliminate the grief that was inherent in my job.

After several years of effort and some mighty handy software programming from my guru buddy Brian, we created a solution that helps me when I’m on the road and from any computer in the company. I can now get a record to support the Customer and answer a question or look at the details of a procedure that was always somewhere else other than right where I needed it, exactly when I needed it. The vast majority of my job-related problems are solved and every Customer and Supplier that interacts with me and the solution wants one for themselves because they suffer the same way I used to suffer. I was finally inspired under the right circumstances to solve my everyday problems and I’m going to share it with everybody.

Ask yourself these questions: How much grief will I experience by the end of the day because of my quality program? Doesn’t my business need an Efficient QMS™ that eliminates dinosaur eggs to enable me to lay-back and finally enjoy the view?

]]> http://www.as9100-quality-system.com/blog/?feed=rss2&p=7 1 http://www.as9100-quality-system.com/blog/?p=9 http://www.as9100-quality-system.com/blog/?p=9#comments Wed, 01 Apr 2009 18:22:42 +0000 admin http://www.as9100-quality-system.com/blog/?p=9 Our response to a request from Stewart Industries for a Positive Recall Procedure to use with their AS9100 system:

Positive recall is dependent upon the affected process, such as Calibration, Nonconformance, Inspection Records, Product Traceability and much more…

AS9100 requires a trail of bread crumbs for all activities, which makes records available for audit that can be used to achieve positive recall. The most generic approach to positive recall is preparation of logs that can be sorted to find appropriate information.

AS9100 refers to positive recall in paragraphs 7.4.3 Verification of Purchased Product and 8.2.4. Monitoring and Measurement of Product. We implement positive recall using logs for each affected process; for instance, find useful positive recall instructions embedded in our QMS-15 Calibration Procedure. Search for the word recall throughout the procedure to find relevant instructions that could be adapted to any production activity. The calibration procedure uses a recall card from our Calibration System Forms that could also be adapted for any process.

QMS-09 Receiving Procedure requires inspection records for all materials that can be used for traceability and recall. Materials that have an expiration date have an additional requirement to complete a log, which will be used for recall when they expire their shelf life.

QMS-14 Control of Nonconforming Product requires a log for suspension of Material Reports and segregation of materials that are pending disposition.

Throughout the manufacturing or service process there are numerous opportunities to create logs that could be used for positive recall similar to the methods described in the calibration procedure.

Please visit our AS9100 Kit at:

http://www.as9100-quality-system.com/#as9100qualitysystemkit

We offer a very effective method to manage logs using our Efficient QMS, which enables the User to schedule important events, such as log entries for calibration, nonconformances, expired materials – deadlines and schedules of any kind. The login screen displays pending and overdue events for each person that is affected by a scheduled event and all records are contained in a database that can be searched and sorted for recall information. Please learn more about eQMS at: http://www.efficient-quality-program.com/

Hope this information helps your project.

]]> http://www.as9100-quality-system.com/blog/?feed=rss2&p=9 1 http://www.as9100-quality-system.com/blog/?p=8 http://www.as9100-quality-system.com/blog/?p=8#comments Sun, 16 Nov 2008 15:56:07 +0000 admin http://www.as9100-quality-system.com/blog/?p=8 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.

]]> http://www.as9100-quality-system.com/blog/?feed=rss2&p=8 1 http://www.as9100-quality-system.com/blog/?p=5 http://www.as9100-quality-system.com/blog/?p=5#comments Thu, 18 Sep 2008 03:30:00 +0000 admin http://www.as9100-quality-system.com/blog/?p=5 Many of today’s quality management systems don’t require certification – they allow you to assert your compliance to the standard, but that doesn’t get you a pedigree – you’ll have to romance your Customers to get them to believe your compliance. There’s nothing like providing your pedigree to win a Customer’s confidence. The certification number allows you to get past the “overhead” questions and get down to business (price and delivery), which makes the investment of your time to achieve certification “golden”. Unfortunately, every standard is written to be effective, which means you have to find a way to make your implementation of the standard efficient – no worries – Efficient QMS™ makes any quality management system efficient using existing employee(s). Click here to learn how I used eQMS to certify my employer’s QMS.

]]> http://www.as9100-quality-system.com/blog/?feed=rss2&p=5 2 http://www.as9100-quality-system.com/blog/?p=4 http://www.as9100-quality-system.com/blog/?p=4#comments Mon, 18 Aug 2008 16:40:42 +0000 admin http://www.as9100-quality-system.com/blog/?p=4 Well, if you can get the return you seek on your investment of time and resources by implementing MIL-I-45208 and you know your investment will survive the next couple of years of Customer scrutiny, then MIL-I-45208 is the best choice for a quality management system. It is the most popular name-brand QMS in existence; however, if you can see the writing-on-the-wall from your present and future Customers that think they need their Suppliers to display a pedigree for their QMS before they’ll consider them as an extension of their business, then you’ll need a more effective QMS like AS9003. The MIL-I-45208 inspection system was made better by the AS9003 inspection and test system. Boeing used AS9003 for years as their bare-minimum quality system for Appendix B Suppliers. They’ve decided to phase-out AS9003 by end of June 2008 in favor of AS9100 certification by a Registrar that is listed in the IAQG OASIS database. Boeing has now made one of the most complex quality systems an entry-level QMS. Do you realize that AS9100 is several orders of magnitude more complex than MIL-I-45208? If you’re a Boeing supplier that is fearful of the meager amount of time left to get your system certified, you better get your Registrar scheduled now or you’ll miss the due date. Registrars that can certify an AS9100 QMS are booked solid through the end of this year. Its a cash-cow kind of business now-a-days. We’re doing what we can to help businesses convert to AS9100 by offering an inexpensive Kit of documents that has a proven track record. We’ve also bundled our Kit with Efficient QMS™ that turns the effective AS9100 QMS into an efficient QMS for any size business.

]]> http://www.as9100-quality-system.com/blog/?feed=rss2&p=4 1 http://www.as9100-quality-system.com/blog/?p=3 http://www.as9100-quality-system.com/blog/?p=3#comments Wed, 17 Oct 2007 04:08:06 +0000 admin http://www.as9100-quality-system.com/blog/?p=3 Welcome to the eQMS Blog – we are prepared to support any quality improvement project on your list of actions.

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