Development, installation and maintenance of inspection and procedures including sample plans for determining acceptable levels of quality prior to use:

• Plans, procedures and facilities for handling discrepant material
• Efficient operation of incoming material quality assurance that does not cause undue downtime
• Sufficient information concerning inspection and test results so corrective action can be initiated, vendor rating programs and future purchasing decision should be based on vendor performance history
• Economical statistical sampling procedures to appraise inventory quality, determine deterioration rates, and provide feedback to design, purchasing, and production which will aid in maximizing inventory serviceable life

To measure performance and efficiency of incoming material quality assurance, measurements should be made.  Performance measurements can include, % of incoming lots rejected, lots reworked, lots sorted, lots returned to vendor, lots scrapped, time to complete inspection, lots inspected per day, backlog of logs awaiting inspection, and backlog of lots awaiting disposition. It is not always necessary to provide incoming inspection on every item, but every item must be thoughtfully reviewed to determine if such assurance is required or can be omitted. Omit incoming inspection by plan, not by accident!

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1. Design Control
2. Incoming Material Control
3. Product Control
4. Special Process Control

So what does product control really mean in a manufacturing environment?  I have discussed Design Control Principles for Total Quality Control, and Quality Assurance – Incoming Inspection.  The manufacturing of product is the next step in the Total Quality Control process.  The control of manufactured product is critical in the process of total quality control.  If you have a robust design and raw materials which meet requirements, you must ensure the manufacturing process will consistently produce product which meets the customer requirements.  This is typically verified through product validations.  Inspecting quality into the products can result in excessive scrap and failures in the field.  Therefore, validating your product is a worthwhile venture.

Product Validations are sometimes conducted throughout the design phase.  Product Validations can be conducted on both prototypes as well as finished product manufactured for end use.  Validations should be conducted prior to release to ensure the end users requirements will be met before product release.  The use of the final raw material designs and manufacturing work instructions should be used to produce product for validation testing.

Some typical steps to perform Product Validation are as follows.

• Assign a Validation Team and include the Quality Department to ensure all quality and regulatory requirements will be met in the scope of the validation.
• Develop a Validation Protocol or Test Plan to predetermined criteria which ensures the product will meet customer needs and product specifications.
• Have trained resources to execute the plan validation plan so the requirements are not misinterpreted.
• Run pre-production pilots to debug manufacturing processes and tooling.
• Validate all manufacturing work instructions, finished product, user manuals, instructions for use, and service manuals etc.
• Conduct all required Inspection and testing to an approved statistical sampling plan.
• Schedule Design Reviews to ensure project in under control and the plan is acceptable to all departments involved in product release.
• Complete any necessary revalidations or corrections if product or process failures occur
• Ensure the process produces acceptable product consistently to the predetermined criteria outlined in the validation plan.

The subject of validation is much too large to address in this article.  If you are interested in learning more contact me.

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Product concepts are developed and evaluated against the criteria of meeting the market requirements. Defining the market requirements for the product includes user intended use as well as the regulatory and legal requirements of the product. Gathering marketing information on the user requirements should not be overlooked. Developing a product which does not meet the customers’ requirements will ensure trouble down the road. Take the time to talk with the end users.

ISO 9001 section 7.3 Design and Development references seven process steps to follow to ensure the compliance of the products development life cycle.

These requirements are as follows:

1. Design and Development Planning
2. Design and Development Inputs
3. Design and Development Outputs
4. Design and Development Review
5. Design and Development Verification
6. Design and Development Validation
7. Control of Design and Development Changes

Planning

Planning is sometimes viewed a road block for the design team. Having a good plan is half the battle. Assign a Project Manager to create a plan which lists all the tasks that must be accomplished, assigned responsibilities, and set achievable deadlines. Communicate the updated plan throughout the development cycle. The Project Manager needs to keep the team on task and account for the successful completion of the activities.

Inputs

Once you have a good understanding of the end user requirements, regulatory and legal requirements, it is time to document your design input requirements. Design input requirements will drive the product specifications. Design inputs must be defined before beginning the development of the product. Design to the specifications and end use requirements.

Design inputs should include but not limited to the following:

• Product Intended Use
• Functional Specifications, Performance Specifications
• Physical or Chemical Characteristics
• Human Factors
• Safety, Customer, Regulatory or Legal Requirements
• Customer Specifications
• Software Requirements
• Labeling Requirements
• Risk Management

Outputs

Design outputs are the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the design history file. Every design input requires a corresponding design output. Each design output shall be documented and expressed in terms that can be verified and validated against design input requirements. The design outputs must contain or make reference to acceptance criteria. The design output should be examined against characteristics related to safety, labeling, packaging, materials, and manufacturing processes to determine if they have been addressed appropriately.

Design Review

The purpose of a design review is to document a comprehensive, systematic examination of a design against the design requirements, to evaluate the capability of the design to meet these requirements, to review and update the plan, to identify problems and actions items. Conducting periodic design reviews throughout the project will keep the project team on task as well as insuring the end product design will meet the original design intent.

Verification and Validation

Design verification is a confirmation that the design output meets the design input requirements. This is accomplished by examination and objective evidence that the design input requirements have been fulfilled. While, design validation establishes by objective evidence that the product conforms to user needs and intended use(s). The validation process is typically conducted after the design verification. The validation process is to be conducted on product that is intended for distribution or the design that represents the equivalent design and final processes found in the product to be distributed. Validation testing should be conducted under actual operating conditions or simulated use environments.

Design Changes

Design changes will always occur once the design and specifications are released. A review of design changes shall include evaluation of the effect of the changes on constituent parts and product already delivered to the customer. Following the design control process is imperative when making a design change to assure the changes will not negatively affect the intended use of the product.

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In general if you had to answer the question, “What is Quality?” you could find this definition:

Quality is the measure of excellence or state of being free from defects, deficiencies, and significant variations. ISO standards define quality as “the totality of features and characteristics of a product or service that bears its ability to satisfy stated or implied needs.”

So how do we achieve Quality in our products and services?  Years ago, the designation was made between manufacturing and inspection.  Inspection Quality Control on the shop floor fundamentally was to protect the consumer from receiving bad product.  The goal was to find the mistakes before the customer did.  Inspection Quality Control has been successful in saving industry a vast amount of money and has contributed toward customer satisfaction.  Inspection Quality Control led the way into Statistical Quality Control.  It was realized that the analysis of machine and tool capabilities, sampling tables and techniques, design of experiments and other procedures could predict and influence product quality.  It was based on the principle that the reason for Inspection Quality Control in the first place was because of unpredictable process variation.  Good inspection could not predict good quality.  Good Inspection Quality Control and good Statistical Quality Control did not make the problems go away.

A. V. Geigenbaum of the General Electric Company defined a new approach to quality, Total Quality Control.  Total Quality Control is defined as, “An effective system for integrating the quality-development, quality-maintenance, and quality-improvement efforts of the various groups in an organization so as to enable production and service at the most economical levels with allow for full customer satisfaction.”  This concept is the quality life cycle which begins at design concept and ends with a product which meets the intended needs of the customer.    This is a concept I truly believe in and have reaped the benefits of true customer satisfaction.  We have all heard the cliché, “Do it right the first time.”  Defects can be prevented so that routine inspections can be reduced.

The four main elements of A. V. Geigenbaums approach are as follows:

1. Design Control
2. Incoming Material Control
3. Product Control
4. Special Process Control

The common denominator to the elements of the A. V. Geigenbaum approach is the word control.  Controls implemented from the design phase through the production phase will ensure the product will meet the intended use and achieve customer satisfaction.  I will follow this article with four articles on these control mechanisms.

Until then, enjoy the World of “Q”!

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ISO 9001 Fishbone Diagram.pdf (461 KB)

Training your employees to report problems in a timely manner is important.  Once the problem has been identified, a document a clear description of the problem to include the product part number, lot number, quantity, time period, manufacturing operation and other descriptive information so that the non-conforming material can be identified and quarantined.  It is clearly time to conduct a root cause analysis using the Cause and Effect – Fish Bone Diagram.

Clearly state the actual non-conforming condition and data as well as including the specification and tolerance range which the product failed to meet.  Complete all necessary paperwork to document the non-conformance following your company’s standard operating procedure.  Clearly documenting in the non-conformance in a Corrective and Preventive Action Report (CAPA) will aid in the investigation and disposition of product.

Conduct a brainstorming session with the manufacturing, engineering and quality personnel who may have knowledge regarding the process or product to identify possible causes for the problem.  Using a fishbone diagram can help focus on the critical criteria to consider (eg: Machines, Methods, Materials, Measurements, Mother Nature (Environment), and Manpower (People).  Conducting a thorough root cause analysis is critical. Based on the brainstorming session, each possible cause needs to be investigated to determine a solution.  Asking the five “why’s” often gets to the root of the problem.

Cause and Effect Diagram

Often times there are more than one root cause or a combination of causes between machines and methods or people and measurements, etc.  Root causes can be reviewed to determine the top priority based on risk.   Once the causes are identified, solutions must be put into place.  A good rule of thumb would be to complete investigations within 30 days.  After 30 days, information and recollections of events becomes diluted.  Root causes and corrective actions should be documented into the CAPA investigation plan with assigned responsibilities and timelines.

FISH BONE DIAGRAM

Follow up is the key to success.  Determining the effectiveness of the corrective actions will determine if the root cause analysis and corrective actions implemented were effective.  Effectiveness can be determined by measurement, trending, inspection, validation, or outside verification.

Keeping management involved and informed of the corrective and preventive problem solving process will ensure support in your organization.  The Corrective and Preventive Action system should be a topic for discussion at management review.  Maintaining an effective CAPA system plays ensures the effectiveness of the ISO 9001 Quality Management System in your organization.

Enjoy the World of “Q”

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