We're on-call to facilitate your compliance project to enable basic quality control management, answer your questions and mentor your improvement team: 719-649-4242
Call to brainstorm about your project or to ask questions: (719) 649-4242
We offer open-book demos to ensure an informed decision and immediate download to support your schedule.
Free Download: Typical Schedule/Plan for QMS Registration - prorate the dates to define your Company's improvement schedule.
Fundamentals of basic quality control 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
Click here for guide about how to begin your Company's basic quality control management plan using At-PQC™ templates.
Click here to learn about the responsibilities of a QA manager.
Click here to browse an 8-Step QMS Implementation Plan
The simplified approach to basic quality control management:
- 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 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 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.
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
Browse the library for fresh and often unexpected solutions for basic quality control management improvement projects that competitive businesses are adopting to satisfy their Customers and business goals.
1) Tailor QMS-00 to display Company business information then read the 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 define your Company's improvement schedule.
The first informal basic quality control management meeting should establish the goal of compliance to the QMS and its schedule. The Company can immediately demonstrate their commitment 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 basic quality control 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 for your basic quality control management plan.
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 assessment form.
For more details, download the following typical implementation schedule:
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The QM is responsible for the administration of the Quality Plan and has the authority to manage all work affecting quality. The QM will provide leadership for the development, implementation, communication and maintenance of policies and procedures for the Company according to the approved program. A primary goal is to achieve a high degree of joint ownership of compliance strategies with all of the major operational stakeholders in the Company while addressing regulatory requirements in an effective, timely and responsible manner.
- Formulate and manage the development and implementation of goals, objectives, policies, procedures and systems pertaining to the assurance and regulatory functions.
- Develop, implement, communicate and maintain a plan to bring the Company's Systems and Policies into compliance with requirements.
- Manage documentation related to Program guidelines.
- Project lead for cross-functional projects including determining QA timelines, plans and position strategies.
- Manage and maintain 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 basic quality control management improvement initiatives (Cost reductions, Audit system, CAPA system, etc.) for all products, processes and services.
- Manage and maintain the Company's internal audit program and assess improvement initiatives resulting from all 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 basic quality control management system.
- Manage and maintain the Company's 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 basic quality control management system, any non-compliance issues and recommended actions.
- Minimum of 5 years of System supervisory/management experience within a related industry.
- Experience interacting with regulatory authorities.
- Experience in basic quality control management systems.
- Experience in 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).
- 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 manager should be familiar with basic quality control management tools for problem solving, process management and various metrics. QA managers use problem solving tools to determine root causes and suggest solutions from various perspectives using data to make decisions.
Problem solving tools include:
- The 7 Basic Quality Tools using Pareto charts, cause and effect diagrams, flowcharts, control charts, check sheets, scatter diagrams and histograms.
- Basic quality control management and planning tools using Affinity diagrams, tree diagrams, process decision program charts, matrix diagrams, interrelationship digraphs, prioritization matrices and activity network diagrams.
- Process improvement tools using root cause analysis, PDCA, six sigma DMAIC model, failure mode and effects analysis and statistical process control.
- 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.
- 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:
- Planning and setting goals
- Establishing controls
- Monitoring and measuring performance
- Cycle-time reduction
- Waste elimination
- Theory of constraints for local vs system optimization and physical vs policy constraints that affect throughput
- Elimination of special causes of variation
- Maintaining improvements
- Continuous improvement
- Process mapping
- 5 S's
- Just in time
- Value streams
Measurement, assessment and metric tools include:
- Goal-question-metric modeling to identify when, what and how to measure projects and processes
- Sampling techniques when appropriate
- Statistical analysis to measure central tendency, dispersion and types of distributions to monitor processes and make data oriented decisions
- Trend and pattern analysis to assess data-sets, graphs and charts for various cyclic, seasonal and environment trends and pattern shifts
- Theory of variation to identify common and special causes of variation
- Process capability using Cp and Cpk indices
- Reliability and validity measurement theories using content, construct and criterion types of measures
- Qualitative assessments using anecdotal feedback, observations and focus group output instead of objective measurements
- Survey analysis interpretation
Additional manager skills include:
- Customer relationship management to ensure partnerships and alliances
- Energizing internal Customers to improve products, processes and services
- 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
- Measurement of Customer satisfaction and loyalty using complaints, surveys, interviews, warranty data, value analysis and corrective actions
- Conflicting requirement resolution and basic quality control management of resources
Here's an introduction to basic quality control management using Efficient QMS™ to upload, edit and release a basic quality control manual:
Bare Minimum ISO 9001 Kit for business that don't want any more documents than necessary to comply with the standard.
Basic quality control management best practices for any small business (starter and comprehensive kits)
Construction Templates 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.
For instance, your Company wants a particular job but doesn't comply with the Customer's requirement to have a certified management system. You know your Company can do the job so you approach the Customer to ask them to consider your proposal. You know if you only had a chance to wine-and-dine the Customer and give them a good show-and-tell that you could convince them to give you the job.
The hopeful result of your Company's "romance" with the Customer is to convince them to buy.
Sometimes, "romance" works but wouldn't it be easier and better business strategy to simply replace the romance with full compliance to Customer requirements?
Need help to immediately develop "show-and-tell" that will give your Customer a "warm-and-fuzzy" about your business?
Use our no-charge support by phone and email to kick-start your compliance project - 719-649-4242.