Basic Approach to Quality Control Plan Management

 


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Call to brainstorm about your project or to ask questions: (719) 649-4242

Featured Resources:

Bare Minimum ISO 9001 Kit for business that don't want any more documents than necessary to comply with the standard.

Basic Quality Plan best practices for any small business (starter and comprehensive kits)

Construction Quality Control Plan Government-Grade plan that is compliant with USACE, ICC-ES AC10, IAS AC291 & AC472

Enhanced MIL-I-45208 Inspection System kit, for businesses that produce or manufacture according to their Customer's requirements (build-to-print). The kit complies with "SIP 016 Appendix A" dated 4-15-2010 for Suppliers that produce "Minor Components", which is Lockheed Martin's replacement QMS for Inspection System MIL-I-45208.


Efficient QMS™ - Simple, Cost Effective, Cloud-Based, Paperless Quality Management System

Click here to browse list of training videos to learn how to apply the features of Efficient QMS™.


Standardized FAA Quality System for PMA and Type Certificate Holders - 14 CFR Part 21.137



Click here to browse our most popular quality control plan tools and templates. We offer open-book demos to assure an informed decision and immediate download to support your schedule and products priced right to eliminate tech-writing expenses.

Click here for template instructions and guide to becoming the all important QMS Facilitator. No matter what - someone has to become the quality control plan subject-matter-expert to help the Company earn their QMS pedigree. We'll help facilitate your project with no-charge Consulting by phone and email when you need it most - 719-649-4242.

Click here to learn about the responsibilities of a quality manager.



Click here to browse 8-Step QMS Implementation Plan



Shortcut to latest additions to the catalog and list of top ten budget and pedigree products that competitive businesses are adopting to satisfy their Customers and business goals.

Browse the quality control plan library for fresh and often unexpected solutions for quality improvement projects.



Fundamentals of quality control plan management:
#1 the Customer establishes the definition of quality
#2 if measurements are not performed then improvements cannot be made
#3 do it right the first time



An ISO pedigree helps businesses to:

  • Enhance Customer satisfaction

  • Manage processes effectively

  • Meet Customer and statutory-regulatory requirements

  • Skip the bulk of the Customer romance phase1 to enable focus on the contract and your price and delivery



Testimonial:

WOW....you indicated great service and your email response came within minutes of my inquiry!

Impressive!

Thank you,

Metal Fabricators

Gaithersburg, Maryland



The simplified approach to Quality:

  • Clearly understand Customer requirements, make sure the requirements can be met, keep the Customer informed and track Customer satisfaction;

  • Collect information, determine its meaning and make improvements;

  • Control and maintain necessary measurement and test equipment and use the equipment in the appropriate work environment;

  • Control Customer property to prevent damage;

  • Create and maintain a satisfactory workplace, prepare people for the job and provide resources for the system;

  • Define a quality policy, provide a vision and demonstrate commitment;

  • Define and measure important product, process and service characteristics against requirements;

  • Determine process functions and interactions ahead of time, then control the processes;

  • Determine the root cause of problems, fix the cause of the problem and verify the corrections are permanent; practice, practice, practice continuous improvement

  • Establish the responsibility for providing quality products and services and keep everyone informed;

  • Examine internal operations and report the results to management;

  • Identify good and bad items, preserve good items, keep bad items away from good items and determine what to do with bad items;

  • Keep track of delivered products and services and ship only what was ordered; know what you need to purchase and check-out your Suppliers;

  • Know what you are designing and create a design plan, identify measures for the success of the plan and review the design as it progresses, verify the design does what it has promised and control changes;

  • Make instructions available to Operators, keep the instructions up-to-date and maintain necessary records of activities;

  • Say what you do and do what you say;

  • When the product can't be checked then check the process to ensure it remains capable;

  • Write down the important functions, match the spec to the task and organize your system to achieve quality.

Home | Get the free Adobe Reader to evaluate our demo docs.



Click here to browse list of training videos to learn how to apply the features of Efficient QMS™.



8-Step Overview of QMS Implementation using At-PQC™ Kit:

1) Tailor QMS-00 to display Company business information then read the quality manual and note each referenced document.

2) Skim each referenced document and note each additional reference then skim those documents (forms and procedures).
Significant documents in the kit have been skimmed or read except non-referenced documents, which are value-added and should be archived until needed.

3) Open file named "schedule-to-qms-registration-rev-orig.doc" then prorate the dates to fit the improvement schedule.
The first informal management meeting should establish the goal of compliance to the QMS and its schedule. The Company can immediately demonstrate their commitment to quality by sharing the tailored manual and schedule with Customers.

4) Skim file named Quality Systems Assessment then complete the first half of the assessment, which is to identify Company policies, procedures and forms that comply with the standard. Add references to existing procedures and forms to supplement the first half of the assessment.

5) Complete the second half of the assessment, which is to identify where in the production process the Company complies with the standard. References may include but are not limited to testimony from employees and/or specific references to work records such as purchase order numbers, part numbers, inspection and production records, change orders, contract reviews, management reviews, training records, etc.

6) In parallel with steps 4 and 5, facilitate a management meeting to establish the goal of compliance with the new QMS and its implementation schedule. Use form named Management Meeting Report to create meeting minutes. Record something in each section - especially closure of action items. Actions from management meetings should be tracked because they become evidence of continuous improvement.

7) Facilitate orientation meetings with all Employees and clean-up the facility using 5S:
Sort-Straighten-Shine-Standardize-Sustain. If desired, substitute "Straighten" with "Set-in-Order".

8) Assert compliance with the QMS. Certification of the QMS by an ISO 9001 Registrar is not mandatory but the Company must substantiate assertions with the quality system assessment form.

For more details, download typical implementation schedule:

Schedule to achieve QMS Certification Free download - MS Word format - pro-rate dates to match your schedule



Template Instructions:

Search for the word "your" using your word processor and replace the appropriate text with your business name or logo to make the template appear as though you created it. Demos display watermark and are Adobe encoded but downloads have no digital rights management restrictions or watermarks. You can use them on as many computers as needed in your business operation according to our license agreement. Click here to browse agreement.

Help facilitate your QMS transition using the following guide to implement any quality system:

The quality system survey is the implementation guide for any quality management system. Answers to survey questions are contained in the quality manual and documents that are referenced by the manual.

We suggest you read the entire quality manual to understand the scope of the quality assurance system project and whenever the manual refers to a procedure or form then collect and stack the applicable documents. During review of the manual only skim through the referenced documents to maintain attention on the manual. There may be several documents in our Kits that the quality manual does not reference but keep them handy because they are needed to answer all the questions in the survey.

After review of the manual then start to complete the survey. At first, only answer questions in the survey that can be answered by referring to paragraph numbers in the quality manual. When all "quality manual" related questions are answered then start to review the documents that were referenced by the manual. Refer to the quality manual, referenced documents and non-referenced documents in your Kit until all questions are answered in the survey. When the survey is complete then integrate the procedures and forms into your business operation.

During the above process you will have educated yourself about your quality system, which will help you to facilitate the transition with your employees and to prepare for interaction with your Registrar and Customers.

All you need to implement a fully conforming quality management system is contained in our Kits. Many Kits contain "value-added" documents because of feedback from our Customers. Their Customers always have additional needs and the "value-added" documents provide much needed support.



Most popular tools


AS9100C Aviation, Space and Defense Quality System Starter Kit, $197

AS9100C Lean and Comprehensive Kits, $297 - $397

AS9100 B to C Upgrade Kit, $197


Construction Project Inspection Test Plan Templates Kit, $97


Construction Project Quality Manuals, $47 - $97 - quality system manuals


Construction Project Plan, starter and comprehensive kits $127 - $157


Construction Quality System, Building and Government Grade, $297, compliant with AC10-AC472-AISC-USACE


Construction Quality System, ISO Compliant, Complete Kit $397


FAA PMA, Fabrication and PAH Kit, $297

FAA Repair Station Kit, $197, includes training manuals.

AS9110 Maintenance, Repair and Overhaul Kit, $397


ISO 9001:2008 Quality Plans, $197 to $397, Templates for Build-to-Customer Print, Design, and Service type businesses.


MIL-I-45208 Inspection System Kit, $197 - name-brand system still as popular as ever...


MIL-I-45208 Enhanced Inspection System kit, $297, for businesses that produce or manufacture according to their Customer's requirements (build-to-print). The kit complies with Lockheed Martin's "SIP 016 Appendix A" dated 4-15-2010 for Suppliers that produce "Minor Components", which is a replacement QMS for Inspection System MIL-I-45208.


Quality Control Manuals, $37 - $97
Manuals for AS9003, ASA-100, AS9100 series, Commercial, Distributor, ISO 9001, Laboratory, Machine Shop, Manufacturing, MIL-I-45208, MIL-Q-9858, Sheet Metal, Software, Total Quality - and more...


Quality Control Procedures, $17 - $97
Procedures for Calibration, Configuration Audit/Management, Contingency, Contract Review, Cost of Quality, Crimp/Soldering Training, Design Review, Drawing Review, ESD, First Article, General Workmanship, Standards and Reagents - and more...


Quality Management System Kits, $17 - $397
Kits for Audits, AS9100 series, Bulletin, Calibration, Distributor, FAA, ISO 9001, Machine Shop, Manufacturing, MIL-I-45208, MIL-Q-9858, Nonconformance, Sheet Metal, SPC - and more...


Quality Control Forms, $9 - $137
Action Item/Plan, Calculated Risk, Calibration, Certificate of Conformance, Certificate of Origin, Chain of Custody, Contract Review, Corrective Action, Cp Cpk Cpm, Customer Perception Survey, DD250, Dimensional Analysis, First Article - and more...


Quality Control Forms, Kit, $197 - over 100 forms to support just about any business operation.



7-Page Quality Manual for ISO 9001:2008 and/or AS9100:

Condensed Quality Manual briefly describes the management system.



- Efficient QMS™ Web App Cloud Software Program -

Are you driven to convert your effective or undocumented QMS into an efficient quality management system to survive implementation and maintenance of standards like AISC, AS9100, AS9110, AS9120, ISO 9001, FAA FIS, FAA PMA, FAA Repair Station, IAS AC291 or AC472, Nadcap, USACE or other comprehensive QMS that you know is required to compete in today's world market?


Recent Questions from Customers:

We are a two person shop and need some help to quickly become compliant with a Customer requirement. Do you have something we can use?

We have 47 Employees and lots of Customers. One of our team members in a recent management review meeting suggested we find something that will simplify things. Can you help?

Our small business has used MIL-I-45208 for years but our local QAR just rotated to another person and he wants to change our contract to require compliance to ISO 9001. We can't afford to give an arm and a leg to get compliant with ISO and there's no time in our delivery schedule to implement all this stuff. We could renegotiate the contract but we don't want the hit to our ABVS score. We really need something that's easy to maintain and won't cost an arm-and-a-leg. Will your eQMS thing do the job?

We've got tons of records in storage and we're constantly adding to it. We recently learned it would cost us over $30K to transfer all of it back to our shop or dispose of it. We have got to do something to get out from under this baggage or $30K will become $100K in a couple of years. Management wants to go paperless but can't find a cheap enough solution. We've looked online but everything is way too expensive, then we saw your Efficient QMS program. Will it really work to help us go from paper to electronic records?


Most businesses don't have a lot of time to develop a quality system and would rather find something that is already done, easy to manage and compliant with Customer requirements.

eQMS was developed by Quality-Control-Plan to help a Company achieve their goal of transitioning from their old culture with over 35 years of MIL-I-45208A and MIL-Q-9858A legacy to a modern AS9100 quality system, which they did within six months and earned a 99% score from Registrar NSF-ISR.

Can you demonstrate, in real-time, your commitment to "quality" through your records, policies, procedures, work instructions and forms whenever or wherever you interact with your Customers?


Click here to browse list of training videos to learn how to apply the features of Efficient QMS™.


Type-in the following address on your portable device (with internet Browser) or click the following link with your computer to begin using eQMS:

http://www.as9100-quality-system.com/demo

User-friendly point-and-click operation. Any device with Browser capability can access and operate eQMS so you're never cutoff from your records or QMS policies, procedures, work instructions and forms, including other categories and business documents that you assimilate into eQMS. The quality system web app software was developed to eliminate undesirable overhead expenses and labor-intensive QMS system maintenance.



Efficient QMS Web App is a simple, cost effective, cloud-based and paperless solution that simplifies management activities for any Company.

User-friendly point-and-click operation.

Does your business need a good set of tools that actually simplifies a modern-day quality management system?

Imagine a point-and-click working environment for a QMS where everybody logs in and is instantly familiar with how things work because it is internet-based.

Users can access QMS documents and fill out forms online using any device with an internet browser - that's any desktop, laptop, netbook, tablet, PDA, Blackberry, iPad/iPhone/iPod and smartphone - any device with an internet Browser.

Records are in a database so they don't have to be transposed to a spreadsheet to analyze and there are no transposition errors.

Action items are displayed as soon as a User logs in and they're all displayed on the Events Calendar. Plus, eQMS sends email notifications and reminders in advance to enable Users to maintain their commitment to the schedule.

The latest revision documents are just a click away and are never caught by an Auditor because they are never out-of-date.

Documents under revision and new documents are controlled through a release process that assures the current documents are used right up to the moment that new documents are released.

Auditors love eQMS because everything they need to substantiate compliance is a point-and-click away.

Customers can log-in using a built-in Customer account that only displays QMS procedures and blank forms to protect proprietary information.

eQMS is expandable to enable access to other Company resources.

Scanned or PDF documents can be attached/embedded in forms, such as certs, receiving reports, contract modifications, drawings and more... If documents are too large to attach or embed in a record then the User can create a link to display the document.

Video training guides are the only resources needed to learn how to use the features of eQMS and they can be expanded to train other Company activities.

Procedures and records can be sent "live" to Customers, Suppliers, Potential Clients and Users to browse or fill out without having to log-in to eQMS.

Any form in the Company can be created using Form Maker and any procedure can be imported and edited using Process Maker.

Forms can be signed by responsible authorities to assure approval to proceed and prevent assumptions.



If you're a small business with few employees and no QMS documents that must compete with large businesses that have a certified quality system, please click here to learn more about the web app software quality management system. If you're a medium-to-large business and must find a way to transition from paper to electronic management then please click here to see for yourself how demo eQMS will make that process less painful.

A QMS pedigree requires extensive resources and tools to achieve certification or accreditation and significant overhead to maintain the system for annual recertification. eQMS was designed to achieve QMS certification using existing employees and significantly reduce or eliminate overhead expenses.

Are you faced with the challenge to increase revenues and think a QMS pedigree will improve your odds? Do your budget limitations force you to call upon your employees to implement and maintain a complex QMS standard with diminishing resources?

All our Customers consider eQMS a formidable tool in their arsenal of business resources to facilitate Company policy and keep "things" under control and continuously improving.

Efficient QMS™ is a self-contained resource that's accessible on your internal network or over the internet. Users can login to mine the data, sign authorizations, do homework, complete unfinished tasks, quote from the manual or procedures, access drawings and work instructions and demonstrate in realtime for your Customers how committed your Company is to quality. Your "office" is always open and your business files are always handy...!

From the Quality Manager of Electro Energy Inc:
"Efficient QMS™ helped us achieve a 99% score from our AS9100 certification audit and helped us maintain our QMS after being downsized. The Auditors from NSF-ISR remarked that our quality program was in their top ten list of best practices."

FYI: Electro Energy purchased the Eagle-Picher (EP) Colorado Springs, CO facility in Oct 2003 and transferred all personnel as assets of the sale. The QA Mgr had been with EP since March 1981 and most other personnel had as many years of experience in the business. Between 2003 and 2005 the Company became publicly traded. It took a couple of years for old management to retire then new management decided on Dec 1, 2005, to acquire an AS9100 pedigree. By July 7, 2006 the Company had its pedigree from NSF-ISR with a 99% score using the cloud-based web app software as the foundation of their quality management system. The QA Mgr knew the sale of EP to EEI would cause a paradigm-shift so he began to develop a web-based QMS in April 2004 to make the culture shock less painful, not to mention that EEI inherited over 30 years of document baggage that had to quickly become "auditable".

Efficient QMS(tm) is a solution for companies that must protect their existing business and desire to compete for more business with Customers that want their Suppliers or Contractors to have a QMS pedigree - or operate with software-based project management tools.

We have very carefully created a cloud-based working environment for management of simple or complex quality systems. We have succeeded in achieving the goal of operating a pedigree QMS without the need to hire additional personnel to maintain the QMS. In addition, eQMS Users are able to maintain a certified QMS when the business is victimized by down-sizing.

We designed the paperless QMS with emphasis on improving the management of Company resources and reducing the labor required to keep things up-to-date.

eQMS enables paperless management of:

  • bulletins
  • calibration
  • changes
  • configuration
  • corrective actions
  • expired materials
  • forms
  • improvements
  • manuals
  • policies
  • procedures
  • production records
  • nonconformances
  • preventive actions
  • purchase orders
  • receiving inspection
  • training
  • work instructions - and more...

Simple, low cost, cloud-based, paperless QMS:

  • has a daily planner with reminder login for Users that can't remember everything they need to do
  • has a video User's manual
  • has easy navigation for all Users with their internet Browser
  • has flexibility to add or remove categories to fit the business operation - and more...

Click here to learn how-to add any word-processed document to eQMS.


Click here to browse list of training videos to learn how to apply the features of Efficient QMS™.


We invented the QMS web app software out of self-preservation and it has saved countless hours of labor and significantly decreased "management" expenses. User's intuitively navigate eQMS because it is browser-based and because it is such a convenient tool to access QMS documents and records after password-protected login.

We recommend installation of eQMS on an external webhost to enable "road warriors" to manage their business in realtime using any device with Browser capability. Not a bad idea if you're sitting with a Customer talking shop and suddenly need to browse some records. Think about the intangible return on investment from increased Customer confidence in the business operation.

Anywhere you can connect to the internet or internal server to login to eQMS is another tool to promote and manage your business.

Click here for more information or click here for demo to vigorously experiment with eQMS.

We are proud eQMS was chosen to support the quality improvement projects for the following services, businesses and agencies. Companies using eQMS have received pedigrees for ISO 9001, AS9100, AS9110 and Nadcap special processes:

Access Laser Company
Alto Aviation, MA (aircraft sound systems)
Arcadia Aerospace Industries
Testimonial: "We went through our Nadcap audit for AQS and NDT/UT and we received no NCR's. The Auditor was very complimentary of our system, which was in no small part because of eQMS."
Avionics Mounts Inc.
axept Custom Engineering (MEMS)
Canadian Solar Solutions Inc.
This manager started working for Canadian Solar Solutions shortly after setting up and operating eQMS for his previous employer, Sustainable Energy Technologies. Because of lessons learned at his old employer, he convinced new management to use eQMS to help them survive a CSA audit in six (6) weeks, which they passed.
Deutsch
(.net) This global Company could route all their satellite businesses through one internet-based quality management system to standardize a critical business operation.
Dynamic Paint Solutions
Dynamic Power LLC
Global Parts Inc.
Howell Instruments Inc.
K-TECHnologies Inc.
Ligi Tool and Engineering Inc.
McAllister Tool and Machine
Midstate Industrial Supply
Mohr and Associates
Nee's Machine Inc.
Nomad Aviation Inc.
Testimonial: "We passed our ISO 9001:2008 registration audit thanks to Efficient QMS...Thank you."
Quipco Al Shoumoukh, LLC
Sandia National Laboratories
Specialty Metals Corporation
Sustainable Energy Technologies
Terratec
Testimonial:
"Terratec was pleased to work with Quality Control Plan during the integration of Efficient QMS (eQMS) into our work processes. We found the cloud QMS to be flexible and the online support exceptional. We do not have an IT department and found the installation to be well within my skill-level as General Manager. There is a learning curve, but it is short, and the results that are achievable in a short space of time are impressive. We look forward to the continuous improvement that can be achieved through an integrated quality management system and thank quality-control-plan.com for providing us with a product that has allowed us to produce an ISO 9001 QMS in a fraction of the expected time."
Theranos
Quest Manufacturing LLC.
Testimonial: "Installing eQMS was very simple. The only issue we had with install on our server was getting the correct library for 64 bit and that was quickly cleared up."

Location of demo Efficient QMS(tm) Price - $497 - includes versions to support ISO 9001 or AS9100C, AS9110A, AS9120A or IAS AC472. Other QMS systems available with prior notice, such as nuclear quality management.

Click the above demo links to see what is included in each version of eQMS using the Customer-type login, which limits access to blank forms and the QA System category to protect confidential or proprietary records.

Login Name: customer
Password: customer

The Customer-type login is very useful because it reduces access to only the category named "QA System" and its blank forms. Other categories added to eQMS are normally proprietary so we built-in a Customer-type login, which can also be used by Suppliers, Auditors, Prospects, Contacts and more...

$497 Efficient QMS™, Complete | Add to Cart | View Cart

Efficient QMS™ web app software quality management system is accessible on any device with an internet Browser, including a WiFi enabled, private network webhost server. Click here for full-access demo to vigorously experiment with eQMS or click here to learn more...

Download and install fully functional eQMS anytime on your webhost or internal server then we'll visit with you to provide a permanent license.



$397 Efficient QMS™, Shell | Add to Cart | View Cart

eQMS Shell is seeded with only a couple of documents to enable businesses to create their own proprietary management system or use it to replace paper forms with searchable electronic forms. Click here for full-access demo or click here to learn more... All the features in complete eQMS are included in eQMS Shell.



Click here to browse list of training videos to learn how to apply the features of Efficient QMS™.



New Features:

  • Ability to allow/disallow editing on data fields by the "customer/customer" login.

  • Ability to change the "customer/customer" login password.

  • Ability to change the encryption key used for generating the Customer Access Link to disable previously emailed links.

  • Allows signature authority Users to have multiple signature images. Signature Users can select a single signature or multiple signatures when "signing" a document.

  • Automatic document revision control and manual document release system. We originally only provided for revision control of forms.

  • Built in HTML editor. We originally did not provide for editing of procedures or work instructions within eQMS - an external editor was required.

  • Enhanced security.

  • Many bug fixes.

  • New Form Maker functions in the design palette.

  • New numerical data input types in forms.

  • Provide Form Maker database content to enable editing of all supplied forms. We originally did not enable editing of supplied forms.

eQMS is not pay-as-you-go software - no subscriptions - no per-User fees - no other expenses - that's refreshing!

Evaluate eQMS to see how it can dramatically improve the efficiency of the quality program that you need to keep your Customers happy. Any size business (including a one, two or three person shop or "big business") can use eQMS to help make the sale to win new business or keep costs way down for existing business. You'll never have to say "I'll get back with you on that..." because all you have to do is login to demonstrate in realtime the Company's commitment to "quality".

You can populate eQMS with any management system - including standards like AS9003, AS9100, AS9110, AS9120, ASA-100, ISO 9001, ISO 15161, MIL-I-45208, MIL-Q-9858, FAA-PMA, NQA-1, FAA Repair Station, TS16949 - and non-standard management systems like Construction, Maintenance, Machine Shop, Engineering, Commercial, Civil, Government - any Customer flowdown quality program or voluntary quality management system!

How will your business spell relief?

Efficient QMS™



Quality Manager Responsibilities:

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 system 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.



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


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JnF Specialties, LLC
664 Greenscape Lane
Colorado Springs, Colorado 80916

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Footnote 1 - Definition: Romance Phase
The time, money and charm that businesses expend to convince Customers to buy products/services.

For instance, you've got a chance for some business with a Customer but you don't have an ISO pedigree number. You really want the job so you apply yourself to get your Customer to accept your show-and-tell and wine-and-dine, which you know will win their respect to give you the job. The hopeful result of all this effort is to convince your Customer to buy, which we call the "romance phase" of the business relationship.

Wouldn't it be easier and better business strategy to simply replace the romance phase with an ISO or modern quality system pedigree number?

Need help with your transition to ISO 9001 - remember - we provide no-charge Consulting by phone and email.





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