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Essay - Implementing A Quality Systems Management Program



1.1.1  When a company does not have a formal, disciplined quality management system, they are undoubtedly experiencing higher cost and lost revenues due to inefficiencies created by higher than necessary rework and/or waste. This higher cost is frequently attributed to low productivity, while in fact it is a direct result of lack of quality. 

1.1.2  This lack of quality subtracts directly from profits and slows down production and delivery of a service. This may result in lost business because of schedule delays or an inability to meet contractual requirements.

1.1.3  This document is to intended to be inclusive of a wide range of quality issues which could adversely affect business, so I wish to expose you to a large range of these concepts even if they do not appear to be the case at present.


1.2.1  There are many contributors to poor quality, all of which have a direct, negative impact on a firm's bottom line. They fall into two general categories:   Administrative/Control Issues, and Production and/or Service Delivery Problems 


1.3.1  The Administrative/control issues set the stage for quality problems which manifest themselves during the production and/or service delivery process. These Administrative/control issues include:   Ambiguous or Unclear Definition of the Customer's Requirements. Unless the customer's requirements are clearly defined and understood, the end result will be unsatisfactory. Design. Quality and “producability” and deliverability must be designed into a product or service from the conceptual phase. Marginal design provides opportunity for error which all too often is turned into defective product or service. of Sub-Standard Suppliers. Sub standard suppliers degrade the end item and detract from the overall quality of the final product or service. Process Control. Inadequate process control permits the production and/or service delivery of borderline product or service or the delivery of sub standard service. Untrained employees unintentionally create quality problems which become self perpetuating.

What happens as a result of  NOT having proper administrative controls?  


1.4.1  Production and/or service delivery problems are the end result of the neglect from the product and/or service delivery design phase through the production and/or service delivery process. All of the following issues add cost to the product or service without adding benefit.   Low Productivity. Efficiency drops as personnel are forced to spend time fixing problems that should have been avoided in the first place. Scrap is the most visible and in many ways the most debilitating to an organization because it is a drain on the resources of the organization. It means that all of the labor, material, machine time and other direct and indirect assignable costs that were spent to produce an item must be scrapped due to some quality problem. The cost of scrap cannot be recovered. This can take the form of extra fuel or excess wear and tear on company equipment as well as scrap in the manufacturing sense. Waste adds cost through material that is left over and can't be used, e.g. materials removed during the production process, and lengths of wood metal shavings removed during a machining process, lengths of bar stockthat are left over and too short too use. This can be minimized through proper planning and design. This is the cost incurred to modify a product that does not currently meet the standard. The modification makes the part meet the print or standard. (e.g. drilling a hole that was missing.) The part will then be indistinguishable from one that was fabricated correctly, but the cost incurred by the rework must be absorbed as part of the cost of manufacturing. Repair is an operation that makes the part useable, although the finished product doesn't match the original drawing, blue print or standard. (e.g. fill a hole that was drilled in error.) The part is useable, but clearly has an irregularity that doesn't match the print. The cost of the repair must be absorbed and sometimes the sell price must be reduced as a concession to the customer.

1.5  The production and/or service delivery problems outlined above create secondary issues which add still more cost without adding value. For example:

1.5.1  Re-inspection. This cost is often buried under the total cost of inspection, but clearly is an added burden caused by the failure of the component to pass inspection the first time.

1.5.2  Shipping And Repacking. Shipping and repacking costs for returned goods are an added expense brought about by poor quality.

1.5.3  Warranty. Costs to perform warranty not covered under any of the headings above.

1.5.4  Claims Adjustments. Adjustments made to accounts receivable to compensate for returned goods or, in this case, possibly lost or damaged goods.

1.5.5  Allowances. Adjustments made to price to compensate the customer for quality problems.

1.5.6  Replacement Material. This is the cost to re-procure and stock replacement material.

1.5.7  Purchasing Overhead. Purchasing overhead required to procure replacement material. (Include planned overages.)

1.6  Every dollar incurred by the cost of poor quality is subtracted directly from profit. It is not uncommon for companies to have a cost of poor quality in the range of 4 to 8 percent of total revenues. while their profit margin is only 2 to 4 percent! 


2.1  Develop a quality policy and ensure that it is understood, implemented and maintained at all levels of the organization.

2.1.1  The Quality Policy must be relevant to the company's goals as a whole, and to the expectations and needs of the customers.   

2.2  Develop an organization chart which clearly depicts the quality organization and where it fits within the company's management structure.

2.2.1  The organization chart must show lines of authority and responsibility, including any dotted line relationships.  (There are formal communications that take place between functional positions that are indicated by dotted lines; but these lines do not transmit directives or authority.) 

2.2.2  Define the written authority and the interrelation of personnel who manage, perform, and verify work affecting quality. 

2.2.3  Define the organizational freedom and authority of those people who: initiate action to prevent the occurrence of any nonconformities relating to product, process, or the quality system;  identify and record any problems relating to the product, process, or quality system;  initiate, recommend, or provide solutions through designated channels;  verify the implementation of solutions;  control further processing, delivery, or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected. 

2.2.4  Identify all of the resources required for: Management of the Quality system,  Performance of Quality System work, and  Verification activities, including quality audits, ensuring that the proper resources will be assigned or available.  Ensuring that the quality personnel are properly trained. 

2.3  Determine the responsible person who as a member of management, irrespective of other responsibilities, shall have defined authority for:

2.3.1  Ensuring that a quality system is established, implemented, and maintained. 

2.3.2  Reporting on the performance of the quality system to the company's management for review and as a basis for improvement of the quality system. 

2.3.3  Developing a position description for the management representative who will be responsible for quality, including external matters relating to the quality system. 

2.4  Establish a schedule for executive review of the Quality system. Ensure that records are kept of this periodic review. 

2.5  Establish, document and maintain a quality system that meets the needs defined in 2.1.1 and ensures that outcome of the system conforms to specified requirements. This system should be driven by the expectations of the company’s customers. 

2.6    Prepare a quality manual that meets the requirements of the appropriate quality standard, ensuring that the quality manual includes or makes reference to the quality system procedures.

2.6.1  This should include an outline of the structure of the documentation used in the quality system.

2.7  Prepare documented procedures consistent with the appropriate quality standard and the company's stated quality policy.

2.8  Effectively implement the quality system with it's documented procedures and checklists.

2.8.1  The range and detail of the procedures that form the company’s quality system depend on the complexity of the work, the methods used and the skills and training needed by the personnel involved in carrying out the activity. Procedures may make reference to work instructions that define how an activity is performed. Additionally, checklists, which provide mutual support for procedures, are an effective method for defining and documenting individual steps many processes. 

2.9  Develop a quality plan that defines how the quality requirements will be met.

2.9.1  The plan must be consistent with the company's other requirements and shall be in a format suitable for the company’s mode of operation.

2.10  Ensure the following activities, as appropriate, are considered in meeting the specified requirements for products, projects or contracts: 

2.10.1  The preparation of quality plans. The quality plans referred to may be in the form of a reference to the appropriate documented procedures that form an integral part of the quality system; 

2.10.2   The identification and acquisition of any controls, processes, equipment (including inspection checklists and test equipment), fixtures, resources, and skills that may be needed to achieve the required quality;

2.10.3   Ensuring the compatibility of the design, the production process, installation, servicing, inspection, and test procedures, and the applicable documentation;

2.10.4   The updating, as necessary, of quality control, inspection, and testing techniques, including the development of new instrumentation;

2.10.5   The identification of any measurement requirement involving capability that exceeds the known state of the art, in sufficient time for the needed capability to be developed;

2.10.6   The identification of suitable verification at appropriate stages in the realization of product or service;

2.10.7  The clarification of standards of acceptability for all features and requirements, including those which contain a subjective element;

2.10.8   The identification and preparation of quality records. 

2.11  Establish and maintain documented procedures for contract review and for the coordination of these activities.

2.12  Establish procedures so that before submission of a tender, or at the acceptance of a contract or order (statement of requirement), the tender, contract, or order is reviewed to ensure that:

2.12.1  The requirements are adequately defined and documented; where no written statement of requirement is available for an order received by verbal means, ensure that the order requirements are agreed to before their acceptance;

2.12.2  Any differences between the contract or accepted order requirements and those in the tender are resolved;

2.12.3  The company has the capability to meet the contract or accepted order requirements. 

2.13  Define, through a written procedure, how an amendment to a contract is made and correctly transferred to the functions concerned within the organization. 

2.14  Ensure the records of contract reviews are maintained, and that channels for communication and interfaces within the organization have been established. 

2.15  Establish and maintain documented procedures to control and verify the design of the product or service in order to ensure that the specified requirements are met.Prepare plans for each design and development activity.

The plans should describe or reference: 

2.15.1  Design and development activities, and define responsibility for their implementation. The design and development activities should be assigned to qualified personnel equipped with adequate resources. The procedure should require that the plans be updated, as the design evolves.Define the organizational and technical interfaces between different groups which input into the design process.

2.15.2  Define the necessary information that must be documented, transmitted, and regularly reviewed.

2.16  Identify, and document design-input requirements relating to the product, including applicable statutory and regulatory requirements.

2.17  Review these requirements for adequacy and make sure the results of any contract review are taken into consideration.

2.17.1  Resolve incomplete, ambiguous, or conflicting requirements with those responsible for imposing these requirements. Ensure that design output is documented and expressed in terms that can be verified and validated against design-input requirements.

Ensure that the design output: 

2.17.2    Meets the design-input requirements;

2.17.3  Contains or make reference to acceptance criteria;

2.17.4  Identifies those characteristics of the design that are crucial to the safe and proper functioning of the product (e.g., operating, storage, handling, maintenance, and disposal requirements)

2.17.5  The procedure should ensure that design-output documents are reviewed before release. 

2.18    Ensure that at appropriate stages of design, formal documented reviews of the design results are planned and conducted.

2.18.1  Participants at each design review should include representatives of all functions concerned with the design stage being reviewed, as well as other specialist personnel, as required. Records of such reviews must be maintained. 

2.19  Develop a design verification procedure that will ensure that the design-stage output meets the design-stage input requirements.   

2.19.1  The design-verification measures must be recorded and may include:  Performing alternative calculations,  Comparing the new design with a similar proven design, if available,  Undertaking tests and demonstrations, and  Reviewing the design-stage documents before release. 

2.20  Establish a design validation procedure that ensures product or service conforms to defined user needs and/or requirements. 

2.21  Design validation follows successful design verification ( 2.19), and is normally performed under defined operating conditions.

2.21.1  Validation is normally performed on the final product, but may be necessary in earlier stages prior to product completion.

2.21.2  Multiple validations may be performed if there are different intended uses.

2.22  Establish a procedure that ensures all design changes and modifications are identified, documented, reviewed, and approved by authorized personnel before their implementation. 

2.23  Establish and maintain documented procedures to control all documents and data that relate to the requirements of the appropriate quality systems standard, including, to the extent applicable, documents of external origin such as standards and customer drawings.

2.23.1  These documents and data can be in the form of any type of media, such as hard copy or electronic media. 

2.24  Develop a procedure that ensures all documents and data will be reviewed and approved for adequacy by authorized personnel prior to issue.

2.25  Establish a master list or equivalent document-control procedure identifying the current revision status of documents.

This master list should be readily available to preclude the use of invalid and/or obsolete documents. In addition this control must ensure that: 

2.25.1  The pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed; 

2.25.2   Invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use;

2.25.3   Any obsolete documents retained for legal and/or knowledge-preservation purposes are suitably identified. 

2.26  Develop a procedure that ensures changes to documents and data will be reviewed and approved by the same functions/organizations that performed the original review and approval, unless specifically designated otherwise.

The designated functions/organizations must have access to pertinent background information upon which to base their review and approval. Where practicable, the nature of the change should be identified in the document or the appropriate attachments. 

2.27  Establish and maintain documented procedures and checklists to ensure that purchased product or service conforms to specified requirements.

Generate procedures and checklists for the company that will:

2.27.1  Evaluate and select suppliers on the basis of their ability to meet requirements including the quality system and any specific quality-assurance requirements;Define the type and extent of control exercised by the company over subcontractors. This should be dependent upon the type of product or service, the impact of subcontracted product or service on the quality of final product, and, where applicable, on the quality audit reports, quality records and/or quality checklists of the previously demonstrated capability and performance of subcontractors;

2.27.2  Establish and maintain quality records of acceptable subcontractors.

2.28  Develop purchasing documents that contain data clearly describing the product ordered, including where applicable: 

2.28.1  The type, class, grade, or other precise identification; 

2.28.2   The title or other positive identification, and applicable issues of specifications, drawings, process requirements, 

2.28.3   Inspection instructions, and other relevant technical data, including requirements for approval or qualification 

2.28.4   Of product, procedures, process equipment, and personnel; 

2.28.5   The title, number, and issue of the quality-system standard to be applied. 

2.28.6   Ensure that the purchasing procedure requires review and approval of purchasing documents for adequacy prior to release. 

2.29  Develop a procedure for those occasions when the company proposes to verify purchased product at the subcontractor's premises. 

The procedure should specify verification arrangements and the method of product release in the purchasing documents. 

2.30  Develop a procedure that will permit the customer or the customer's representative to verify at the subcontractor's premises and the company's premises that subcontracted product conforms to specified requirements.

2.30.1  Such verification will not be used by the company as evidence of effective control of quality by the subcontractor,

2.30.2  Nor will verification by the customer absolve the company of the responsibility to provide acceptable product, 

2.30.3  Nor will it preclude subsequent rejection by the customer. 

2.31  Establish and maintain documented procedures for the control of verification, storage, and maintenance of customer-supplied product provided for incorporation into the supplies or for related activities.

2.31.1  The procedure must ensure that any such product that is lost, damaged, or is otherwise unsuitable for use will be recorded and reported to the customer.

2.31.2  The procedure must clearly state that verification by the company does not absolve the customer of the responsibility to provide acceptable product. 

2.32  Develop a procedure or checklist, if appropriate, to establish and maintain documented processes for identifying the product or service by suitable means from receipt or acceptance and during all stages of production, delivery, and installation. 

2.33  If traceability is a specified requirement, the procedure must include provisions for unique identification and recording of individual products or batches.

2.34  Generate procedures that identify and plan the production, installation, and servicing processes which directly affect quality and ensure that these processes are carried out under controlled conditions. 

Controlled conditions include the following: 

2.34.1  Documented procedures and/or checklists defining the manner of production, installation, and servicing, where the absence of such procedures could adversely affect quality;

2.34.2   Use of suitable production, installation, and servicing equipment or procedures/checklists, and a suitable working environment;

2.34.3   Compliance with reference standards/codes, quality plans, and/or documented procedures;

2.34.4   Monitoring and control of suitable process parameters and product characteristics;

2.34.5   The approval of processes, checklists, and equipment, as appropriate;

2.34.6   Criteria for workmanship, which shall be stipulated in the clearest practical manner (e.g., written standards, checklists, representative samples, or illustrations);

2.34.7  Suitable maintenance of equipment to ensure continuing process capability.

2.34.8   Where the results of processes cannot be fully verified by subsequent inspection and testing of the product or service and where, for example, processing deficiencies may become apparent only after the product is in use or the service completed, the processes shall be carried out by qualified operators and/or require continuous monitoring and control of process parameters to ensure that the specified requirements are met.  The written procedures must include requirements for any qualification of process operations, including associated equipment, checklists and personnel.  The procedure must also require that records be maintained for qualified processes, checklists, equipment, and personnel, as appropriate.

2.35  Establish and maintain documented procedures and checklists for inspection and testing activities in order to verify that the specified requirements for the product or service are met. 

Detail in the documented procedures (quality plan), all required inspection and testing, and the records to be established. 

2.36  Develop a procedure that ensures incoming product or process is not used or processed until it has been inspected or otherwise verified as conforming to specified requirements.

2.36.1  Verification of the specified requirements must be in accordance with the quality plan and/or documented procedures. 

2.36.2   In determining the amount and nature of receiving inspection, consideration shall be given to the amount of control exercised at the subcontractor's premises and the recorded evidence of conformance provided

2.36.3   Where incoming item is released for urgent production or delivery purposes prior to verification, it shall be positively identified and recorded in order to permit immediate recall and replacement in the event of nonconformity to specified requirements. 

2.37  Develop written procedures that will define how to: 

2.37.1  Inspect and test the product or service as required by the quality plan and/or documented procedures;

2.37.2  Hold product or service until the required inspection and tests have been completed or necessary reports have been received and verified, except when product or service is released under positive-recall procedures. 

2.38  Establish a procedure to carry out all final inspection and testing of the product or service to complete the evidence of conformance of the finished product or service to the specified requirements. 

The quality plan and/or documented procedures and checklists for final inspection and testing of product or procedures shall require that all specified inspection and tests, including those specified either on receipt of product, delivery of service or in-process, have been carried out and that the results meet specified requirements. The procedure should ensure that no product or service will be dispatched until all the activities specified in the quality plan and/or documented procedures have been satisfactorily completed and the associated data and documentation are available and authorized. 

2.39  Develop a procedure or checklist to establish and maintain records which provide evidence that the product has been inspected and/or tested.

These records shall show clearly whether the product or service has passed or failed the inspections and/or tests according to defined acceptance criteria. Where the product or service fails to pass any inspection and/or test, the procedures for control of nonconforming product shall apply. If the procedure or checklist was appropriately applied and the produce or service is deficient then the procedure or checklist should be reviewed for modification to insure that in the future the procedure or checklist will elicit a satisfactory result.  The procedure or checklist should require records that identify the inspection authority responsible for the release of product or service . 

2.40  Establish and maintain documented procedures or checklist to control, calibrate, and maintain inspection, measuring, and test equipment, test software and checklists used by the company to demonstrate the conformance of product or service to the specified requirements.

The procedure should ensure that:

2.40.1   Inspection, measuring, and test equipment and/or procedures and checklists will be used in a manner which ensures that the measurement uncertainty is known and is consistent with the required measurement capability.

2.40.2   Where test software, comparative references such as test hardware, procedures or checklists are used as suitable forms of inspection, they will be checked to prove that they are capable of verifying the acceptability of product or service, prior to release for use during production, installation, or servicing, and will be rechecked at prescribed intervals. 

2.40.3   The company will establish the extent and frequency of such checks and will maintain records as evidence of control.

2.40.4   Where the availability of technical data pertaining to the measurement equipment is a specified requirement, such data will be made available, when required by the customer or customer's representative, for verification that the measuring equipment is functionally adequate. 

2.41  Develop testing procedures which:

2.41.1  Determine the measurements to be made and the accuracy required,

2.41.2  Select the appropriate inspection, measuring, procedures, checklists, and/or test equipment, that is capable of the necessary accuracy and precision;

2.41.3  Identify all inspection, measuring, procedures, checklists, and test equipment that can affect product quality,

2.41.4  Calibrate and adjust them at prescribed intervals, or prior to use, against certified equipment having a known valid relationship to internationally or nationally recognized standards. Where no such standards exist, the basis used for calibration will be documented;

2.41.5  Define the process employed for the calibration of inspection, measuring, and test equipment, including details of equipment type, unique identification, location, frequency of checks, check method, acceptance criteria, and the action to be taken when results are unsatisfactory; 

2.41.6  Identify inspection, measuring, procedures, checklists, and test equipment with a suitable indicator or approved identification record to show the calibration status; 

2.41.7  Maintain calibration records for inspection, measuring, and test equipment 2.40) 

2.41.8  Assess and document the validity of previous inspection and test results when inspection, measuring, and test equipment is found to be out of calibration; 

2.41.9  Ensure that the environmental conditions are suitable for the calibrations, inspections, measurements, and tests being carried out; 

2.41.10  Ensure that the handling, preservation, and storage of inspection, measuring, and test equipment is such that: 

2.41.11  The accuracy and fitness for use are maintained;

2.41.12  Safeguard inspection, measuring, and test facilities, including both test hardware and test software, from adjustments which would invalidate the calibration setting. 

2.42  Develop a procedure and checklists that will identify the inspection and test status of product by suitable means.

2.42.1  This procedure or checklist will indicate the conformance or nonconformance of product or service with regard to inspection and tests performed.

2.42.2   The procedure or checklist will require the identification of inspection and test status be maintained, as defined in the quality plan and/or documented procedures, throughout production, installation, servicing, and or delivery   of the product or service to ensure that only product or service that conforms to the required inspections and tests [or released under an authorized concession is dispatched, used, or installed. 

2.43  Establish and maintain documented procedures and checklists to ensure that product or service that does not conform to specified requirements is prevented from unintended use or installation or erroneous delivery.

2.44  This control shall provide for identification, documentation, evaluation, segregation (when practical), disposition of nonconforming product or service, and for notification to the functions concerned.

2.45  Define the responsibility for review and authority for the disposition of nonconforming product or service.

2.45.1  Nonconforming product or service shall be reviewed in accordance with documented procedures. It may be:  Reworked to meet the specified requirements,  Accepted with or without repair by concession,  Re-graded for alternative applications, or  Rejected or scrapped. 

2.45.2   Where required by the contract, the proposed use or repair of product or service which does not conform to specified requirements shall be reported for concession to the customer or customer's representative. The description of the nonconformity that has been accepted, and of repairs, shall be recorded to denote the actual condition.

2.45.3   Repaired and/or reworked product shall be re-inspected in accordance with the quality plan and/or documented procedures.

2.46  Establish and maintain documented procedures for implementing corrective and preventive action.  Any corrective or preventive action taken to eliminate the causes of actual or potential nonconformities shall be to a degree appropriate to the magnitude of problems and commensurate with the risks encountered. The company should implement and record any changes to the documented procedures or checklists resulting from corrective and preventive action. 

2.47  Develop procedures for corrective action which include:

2.47.1  The effective handling of customer complaints and reports of product or service nonconformities;

2.47.2  Investigation of the cause of nonconformities relating to product or service process, and quality system, and recording the results of the investigation; 

2.47.3  Determination of the corrective action needed to eliminate the cause of nonconformities;

2.47.4  Application of controls to ensure that corrective action is taken and that it is effective.

2.48  Develop procedures and/or checklists for preventative action which include:

2.48.1  The use of appropriate sources of information such as processes and work operations which affect product or service quality, concessions, audit results, quality records, service reports, and customer complaints to detect, analyze, and eliminate potential causes of nonconformities.

2.48.2   Determination of the steps needed to deal with any problems requiring preventive action.

2.48.3   Initiation of preventive action and application of controls to ensure that it is effective.

2.48.4   Confirmation that relevant information on actions taken is submitted for management review. 

2.49  Establish and maintain documented procedures for handling, storage, packaging, preservation, and delivery of product or service.

2.49.1  The handling procedure will describe methods of handling product that prevent damage or deterioration. 

2.49.2   The procedure will designate storage areas or stock rooms to prevent damage or deterioration of product, pending use or delivery.

2.49.3   Appropriate methods for authorizing receipt to and dispatch from such areas shall be stipulated.

2.49.4   In order to detect deterioration, the condition of product on hand shall be assessed at appropriate intervals.

2.49.5   The procedure will control packing, packaging, and marking processes (including materials used) to the extent necessary to ensure conformance to specified requirements.

2.49.6   The procedure will apply appropriate methods for preservation and segregation of product while product is under the company's control.

2.49.7  The company will arrange for the protection of the quality of product after final inspection and test. Where contractually specified, this protection shall be extended to include delivery to destination.

2.50  Establish and maintain documented procedures for identification, collection, indexing, access, filing, storage, maintenance, and disposition of quality records.

2.50.1   Quality records shall be maintained to demonstrate conformance to specified requirements and the effective operation of the quality system. Pertinent quality records from the subcontractor shall be an element of these data.

2.50.2   All quality records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss.

2.50.3   Retention times of quality records shall be established and recorded.

2.50.4   Where agreed contractually, quality records shall be made available for evaluation by the customer or the customer's representative for an agreed period.

2.50.5   Records may be in the form of any type of media, such as hard copy or electronic media. 

2.51  Establish and maintain documented procedures for planning and implementing internal quality audits to verify whether quality activities and related results comply with planned arrangements and to determine the effectiveness of the quality system.

2.51.1  Internal quality audits shall be scheduled on the basis of the status and importance of the activity to be audited and shall be carried out by personnel independent of those having direct responsibility for the activity being audited.

2.51.2  The results of the audits shall be recorded and brought to the attention of the personnel having responsibility in the area audited.

2.51.3  The management personnel responsible for the area shall take timely corrective action on deficiencies found during the audit.

2.52  Establish and maintain documented procedures and/or checklist for identifying training needs and provide for the training of all personnel performing activities affecting quality.

2.52.1  Personnel performing specific assigned tasks shall be qualified on the basis of appropriate education, training, and/or experience, as required.

2.52.2   Appropriate records of training shall be maintained. 

2.53  Where servicing is a specified requirement, establish and maintain documented procedures for performing, verifying, and reporting that the servicing meets the specified requirements. 

2.54  Identify the need for statistical techniques required for establishing, controlling, and verifying process capability and product characteristics. 

2.55  Establish and maintain documented procedures to implement and control the application of the statistical techniques identified. 


3.1  The implementation of the Quality Systems Management Program:

3.1.1  Identifies areas of the company where quality has been impacted due to lack of a disciplined approach.

3.1.2  Implements a program which will correct the weaknesses and deficiencies discovered through 3.1.1. 

3.1.3  Provides a systematic approach to controlling quality . 

3.1.4  Increases productivity by decreasing quality defects. 

3.1.5  Shortens through-put time. 

3.1.6  Improves the quality of the products and/or services the company provides to it's customers.

3.1.7  Improves overall customer satisfaction. 


4.1  Increase profits. Every dollar subtracted from the cost of poor quality goes directly to the bottom line as profit.

4.2  Improve customer satisfaction. The customer will receive a product or service that meets or exceeds his expectations.

4.3  Enhance quality. The quality will improve and there will be fewer rejects both in the company's facility and from his customers.

4.4  Increase productivity/efficiency. The work will be accomplished with fewer expenditures of hours by the company's personnel.

4.5  Shorten through put. The time it takes to complete a product or provide a service will decrease.

4.6  Expand market potential. The additional capacity that the increased efficiency provides may be used to produce more product or service to the company's customer base.

4.7  Certification. Company's who are required to be certified will be compliant and ready for certification.

4.8  Lower costs. By simply putting in place the appropriate standards described you costs of doing business will decrease. Increased awareness of your problems will necessitate correction.

4.9  Expanded customer base. The number of companies you can do business with will increase by your having accepted the standards.

4.10  Improved market awareness. The awareness of your business by people outside your current sphere of knowledge will increase drastically when they hear or see of your quality improvements.

4.11  Significant improvement in product reliability. On-time deliveries, inventory turnover, decreases in customer complaints and increases in market share and sales per employee are just some of the aspects of improved product reliability.

Increased or improved business overseas or with the government. The certification process (for example, ISO) provides a significant opportunity to establish a quality system with a disciplined, proven method.