chapter iii quality systems summary

8/8/2019 Chapter III Quality Systems Summary

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Table of Contents

The Quality Function....................................................................................................................2

Elements of Quality System (pg 5)...............................................................................................3

Documentation Systems..............................................................................................................6

Configuration Management......................................................................................................6

Documentation Control.............................................................................................................7

Control of Quality Records ...................................................................................................7

Revision Control.......................................................................................................................7

Marking changes......................................................................................................................7

Document formats....................................................................................................................7

Correlation Matrix documents...................................................................................................7

Quality Standards and other Guidelines.......................................................................................8

Specifications .....................................................................................................................8

Industry Standards ...............................................................................................................8

International/Industry Standards ..........................................................................................8

Industry/National Standards .................................................................................................8

Major industry and international standards ..........................................................................8

ISO 9001:2000 Summary............................................................................................................8

Malcolm Baldridge National Quality Award (MBNQA)................................................................10

Audit Purpose and Benefits........................................................................................................12

Audit Philosophy.....................................................................................................................13

Types of Audits.......................................................................................................................13

Audit Program Administration.................................................................................................15

Audit Standards......................................................................................................................15Audit Responsibilities.............................................................................................................15

Audit Scope............................................................................................................................16

Audit Frequency.....................................................................................................................16

Preparing the Audit.................................................................................................................16

Executing the Audit................................................................................................................17

Closing Meeting......................................................................................................................18

Audit report preparation..........................................................................................................18

Corrective action/follow-up.....................................................................................................18

Cost of Quality...........................................................................................................................18

Quality cost categories...........................................................................................................19Optimum Quality Costs..........................................................................................................20

Quality Cost improvement......................................................................................................21

Quality cost comparison bases...............................................................................................21

Quality Cost Responsibilities..................................................................................................21

Advantages of quality cost system.........................................................................................21

Limitations of Quality cost system..........................................................................................21

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Other Quality Cost Pitfalls......................................................................................................22

Pareto Analysis of Quality Costs............................................................................................22

Taguchis Loss Function.........................................................................................................22

Quality Training..........................................................................................................................22

Training to reduce Workmanship Defects...............................................................................23Training for customer interface...............................................................................................23

Training needs assessment....................................................................................................23

Training Guidelines................................................................................................................24

Training effectiveness............................................................................................................24

Training deterrants.................................................................................................................24

The Quality Function

Task of quality department is to coordinate the quality effort. The plan, measure, analyzeand reports quality

o Quality Control- function that is intended to control or regulate the process in

order to prevent defective products from being made. Has to do with makingquality what it should be, and quality assurance has to do with making sure

quality is what it should be.

Main element of a quality system for a manufactured product are

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Any group larger than 25 will require a formal, documented quality system.

Def from ISO 9000:1987 of quality system is the organizational structure,

responsibilities, procedures, processes, and resources for implementing quality management.

Ansi/ISo/ASQ/ Q9000-2000 states

Keys to proper quality system, are:

Elements of Quality System (pg 5)

Quality system informs people involved of how management wants the customerssatisfied. Starts with quality policy (est. by management) then are implemented throughmanagement and the system to assure customer satisfaction

o Quality policy is inteneded to satisfy customer and is the foundation of total

quality hierarchy.

o Quality management- portion of management that implements the quality policy.

In enlightened org the implementation of quality policy is the function of all

management and employees

o Quality system is total org structure, directed by quality management to fulfill the

quality policy. System consists of employees and other resources directed through

procedures. Function to efficiently statisfy customer needs.

o Quality Assurance- planned and systematic actions that provide confidence that a

product or service will satisfy give req for quality. Begin with establishment of

customer expectiations, and contines through the final testing of the product toassure conformance to specs. Ex act are:

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o Quality Control- activities that monitor and control quality

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Formal quality system is document and freeze operations of company. ISO 9001:2000 orISO/TS 16949 are the most common formal quality systems.

Formal quality system is important when product liability is high.

Documents: 1) standard operation procedures 2) procedures 3) work instructions 4) manual

General characteristics of document: Purpose, Basis of doc, scope of doc, goal

Quality Manual

Policy documents (quality policy, commitment to quality and system)

Goal to inform company employees and customers of the management vision andapproach to operating the business.

And define how management intends to satisfy customers for continued businesssuccess.

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Key elements are : 1) policy statement 2) General description of policy implementation3) correlation of policy and implementation to applicable quality standards

Organized along outline of ISO9001:2000, which states the org must establish andmaintain a quality manual that includes the scope of the QMS, documented procedures,and a description of QMS processes

Quality Procedures (or SOPs)

Ways of doing business

Defines management or administrative processes in a manner that supports thecompany policy

They should be:

Work Instructions = Technical Documents

Documentation Systems

Configuration management (for design intensive companies)

Document control (for design and all other companies)

Configuration Management

collection of activities needed to define, identify, manage, record, or approve thehardware and software characteristics of a product.

Described via 2 questions: what constitutes the product at any point in time and whatchanges have been made to the product

o Implies that a system must exist to track the entire product life cycle

Starting point of configuration is baseline. There are three levels

o Functional baseline- general req of the product

o Allocated baseline- defines the general req for the subsystem in the overallproduct

o Product baseline defines the detailed req of the system or item

These baseline doc are detailed include drawings, specs, tests, procedures, parts,

material, etc

Once product baseline approved, changes to the design will fall under configurationcontrol.

Change go through product engineer and other departments- then to configuration board(rep from various departments)

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Is tracking all of the proposed changes and the implementation status of every approvedchange.

Details of every change are recorded and reviewed for existing and future compatibility.

One department (quality) responsible to make sure changes implemented anddocumentation complete

Audits of documentation system for completeness and accuracy, or audits of product toverify engineering specification accuracy.

Documentation Control

Configuration management requires an immense amount of information and requiresdocumentation to be in written form. SO need a methd to file, store, and retrievedocuments.

ISO 9001:2000 requries following control of docs and records

o Document: QMS document must be controlled. A document procedure must existto approve, review, update, and identify the current revision level of QMS docs.

o Docs must have relevant versions available, be legible, readily identifiable, andretrievable.

Control of Quality Records

o Must control and maintain QMS records to provide evidence of conformance otorequirements and of effective QMS operation

o Create procedure to identify, store, retrieve, protect, retain, and dispose of them.

Revision Controlo Keep track of revision and make them available.

o Can revise by section (long docs like quality manual also docs that requirefrequent updates) or by total document (quality procedures and work instructions)

Marking changes

o ISO 9001:2000 requires that changes to quality system docs be identified alongwith the revision level.

o Allows documentation to be of any form or medium.

Most use electronic. One danger is of employees printint out a documentand keeping that version handy

Document formatso Keep all document format consistent. Makes it easy to use and makes it look

professional

Correlation Matrix documents

o Where every requirement of the standard should be identified and broken-outSequence goes as follows

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o What section of quality manual what procedures including equip, records, and

responsibilities any specific work instructions, providing adequate detail toperform work, record information, etc

o Particularly important requirements are the quality records (used to determinecompliance to quality system).

Quality Standards and other Guidelines

- Are measures of excellence against which comparisions are made. Can begovernment or industry endorsed. Can be product specific or genric.

Requirements formal statement of need and a mandatory and expected way to attain it

Specifications

o mandatory requirement; clearly and accurately describes essentialtechnical requirements and verification procedures for items, materials, andservices.

o Can be a statement of a desired or required quantitative goal, often withlower tolerance limits

Industry Standards

o Developed to rationalize and simplify the design, manufacturing, serviceand use of that industrys output. For consistency, industry standards should bebased on internation or national modes

International/Industry Standards

o Example ISO/TS 16949- was modified and adopeted as an automotiveindustry standard

Industry/National Standards

o Examples ANSI and ASME- who have established and executed a quality assurance standard

for design, construction, and operation of nuclear plants.

Major industry and international standards

o Each industry decides what standards are applicable to them. Decision run by regulatory andcustomer requirements

o Organization determines if it ignores quality system req, comply with some or all req, or complywith req and obtain 3rd part registration or accreditation.

ISO 9001:2000 Summary

Scope

o Purpose of this standard is to provide a framework that an organization

uses to 1) demonstrate its ability to supply conforming products and 2) achievecustomer satisfaction.

o Not all requirement in standard applicable to all organizations. Exclusionsallowed if do not prevent the organization from providing products that meetcustomer expections, legal, and regulatory requirements.

o ISO 9000 is a normative reference that provides applicable def and concepts

Terms and definitions

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o Subcontractor = supplier; supplier= the organization; customer= customer

Quality Management system

o Org must establish, document, implement, maintain and improve a quality management systemcovering ISO 9001 requirements.

o Must define and manage processes necessary to achied planned resultsand continual improvement

o Prepare procedurs- effective operation and control of processes.

o Extent of QMS depends on size and type of organization, complexity andinteraction of its processes, and competence of personnel.

o Have documented quality policy and quality objectives; develop qualitymanual and maintain, document procedures, records.

o QMS documents must be controlled, procedure to approve, review andupdate, identify and make revisions. Documents of external origin must beidentified and controlled and prevent unintended use of obsolete docs

Management Responsibilities

o Top management shows commitment to QMS by establishing qualitypolicy and objectives (measurable, consistent, and commited to meeting productreq) and conducting management reviews

o Top management must ensure that customers needs and expectiationare determined, converted into requirement and fulfilled with the aim of achievingcustomer satisfaction.

o Must identify and plan the resources needed to meet quality objectives

o Top management appoints a member of management to be responsiblefor ensuring the QMS processed are established and maintained, reportperformance to top management, promoting awareness of customer req.

o Top management must periodically review the QMS to ensure itscontinuing suitability, adequacy and effectiveness, and evaluation the need forchanges.

Review inputs are performance and improvement oppurtunitiesrelated to audit results, customer input, process performance and productconformance, preventative and corrective actions, follow-ups to previousmanagement review, and changes that could effect the QMS.

Outputs include actions related to improving the QMS, its processes, andproduct improvement related to customer req, along with necessaryresources

Resource management

o Organization determine and provide the resources need to implement andimprove the QMS process and the address customer satisfaction.

o Identify competency needs and provide training for people performingactivities affecting quality

o Ensure employees are aware of importance of their activities

o Identify, provide, and maintain facilities needed to achieve product conformity

Product realization

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o Must Plan the seq of processes to achieve the product, be consistent withQMS req and documented

o Must determine products quality] objectives, processes, documentation,verification and validation activities.

o

Determine, customer requirements, product, regulatory and legalrequirements

o Must plan and control design and development of the product stages

Inputs to requirements- outputs that enable verification of input req- reviewsof design and evelopment held at states to evalution capability of req,identify problems and propose follow up actions- validation to show canmeet intended use requirements changes documented, controlled, verifiedand validated

o Control its purchasing processes to ensure that the purchased productconforms to requirements

o Control production and service operations through availability of product

characteristic information. Production by using and maintaining suitableequipment by use of measuring and monitoring devices.

o Org must preserve product conforminy to customer req during internalprocessing and delivery to the intended destination. (handling, storage,packaging and protection)

o Measuring and monitoring devices must be used and controlled to ensurethat measurement capability is consistent with measurement req.

Measurement Analysis and Improvement

o Organization must conduct periodic internal audits to determine if the QMS conforms to ISO9001 and has been effectively implement and maintained

o Audit take into consideration status and importance of activities, areas to be audited, result ofprevious audits. Procedure, scope, freq, and methodology must be defined. Peformed bysomeone other than who performs activities.

Malcolm Baldridge National Quality Award (MBNQA)

- Signed to law in 1987 (Public Law 100-107). This us award was modeled after Deming prize inJapan and focuses on organization excellence. Based on:

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- MBNQA includes voluntary compliance as well as customer or organizationalmandatory compliance requirements

- Purpose of criteria

-Eligibility categories are :

-It is divided into seven categories with 1,000 possible scoring points. There are 19 items, eachfocusing into a major requirement and addressing one or more areas. Pre-screening ofapplicants and four-stage review process

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-Categories are 1) Leadership 2) strategic planning 3) customer and market focus 4)measurement, Analysis, and Knowledge Management 5) Human Resource Focus 6) ProcessManagement 7) Results.

Criticisms

Requirement comparisons

Audit Purpose and Benefits

o Audits purpose is to examine the effectiveness of management directed control programs.

o Quality assurance philosophy is on prevention rather than detection. If problems occur focus onearly detection, depth of problem, root cause

o Control programs to prevent problems, identify problems, prevent reoccurrences

o Quality problems cause customer dissatisfaction, lost profits, loss of employee morale

o Example of specific auditing purposes:

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Audit Philosophy

o Quality Audits are formal, systematic, and independent.

o Effectiveness and integrity of audit depends on skills and training of auditor.

Auditors must be fact finders, not fault-finders

Audits should not be conducted in a covert manner, avoid secrecy.

Types of Audits

o System Audits

Largest and most extensive of audits (2-5days)

Conducted to verify, through objective evidence, whether or not the qualitymanagement systems and organizational plans are indeed carried out to the

requirements set forth. Can be external (supplier or internal (in-house).

o Process Audits

Large and significant portion of the system audit is devoted to the processaudit. One or more processes audited by systems audit.

Process audit, conducted by itself yield swift results. Since easier to compywith specific process modifications than tackle the deep-rooted managementsystem problems

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o Product Audits

Assessment of final product or service and its fitness for use evaluatedagainst intent of the product or service

Customer oriented

can be done by one auditor or by team of auditors; or internal or external.

o Internal Audits

Performed within an organization to measure its own performance, strengths,and weaknesses against its own established procedures and systems.

Can be performed by in-house personnel or the company may hire outsideauditors.

Considered to be a first-party audit; an audit conducted by the party of thefirst part.

o External Audit

By company directive and performed on an outside source, such as asupplier. Or can be performed by company reps or hire auditors from outside

Considered second-party audit; an audit conducted on behalf of the party ofthe first part (client comp) on the party of the second part (supplier).

o Third party audits

When outside source, or third-party is used to conduct audit; independentsource not associated with the auditees company business.

Used to obtain more independent and objective assessment or achievecertification to a recognized standard.

o Specific Objective Audits (chpII pg 38)

General Audit matrix (pg 39) major category(system, process, product) of specific Audits

System Audit Matrix (Pg 40) types of system Audits

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Audit Program Administration

o Audit authority should

Audit Standards

o ISO 19011:2002

Combines criteria for quality and environmental systems auditing

Address: standards to use in audit process, auditors criteria, monitoring andmaintenance of auditors performance, and code of ethics

o ISO 9001: 2000

Provide international requirements as to what elements are to be audited.

Identifies the requirement to perform internal audits and addresses:

Audit Responsibilities

o Lead auditor responsible for all phases of audit. Responsibilities include:

o Auditors are responsible for:

o The client:

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o

Auditees responsible for

Audit Scope

o Client makes final decision on the scope and depth of an audit, which quality systemelements, physical locations, and org activities are to be audited.

Audit Frequency

o Determined by client, taking into consideration changes in management,

organization, policies, techniques, technologies, as well as changes to the systemitself, and result of recent audits.

Preparing the Audit

o Plan includes:

o Working documents may include: flowcharts and checklists and reporting forms

o Flowchart usuage

Starting point of a system or major audit is important decision. If time start atbeginning if not start at most important time.

Widely used and effective forms of field investigation activities are calledtracing

Flowcharts helpful for trace forwards or backwards audits

Advantages vs disadvantage of flow chart on page 44o Checklists

Distinguishing feature between an audit and other less formal methods ofperforming monitoring.

Guide to each auditor, to ensure full scope of audit is covered. Place torecord data

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Checklist question are not open ended questions, they are individual factsnecessary to form conclusions

Advantages:

Executing the Audit

o Opening meeting

o Evidence collected via interviews, physical evidence, examining docs andrecords, and observation of activities and conditions.

Interviews- questioning auditee personell (most information obtained)by using open ended questions, probing, silience and paraphrasing.Info from interview should be substantiated by evidence inindependent physical sources (docs, witnessed, sampling and

measurement). Also can group interview In-depth interviews used for

Physical Evidence- verification of formal control such as methods,practices, procedurs, policies and documentation done through fieldwork

Verifying documents and records- any supporting auditee

documentation should be noted beneath the corresponding checklistquestion.

o Auditor can review supporting docs at time it is presented alsoif previously obtained during planning phase.

Observation techniques- give particular attention to details that maypotentially result in either pos or neg audit findings. Observationsshould be traceable to time, location and conditions under which theywere made

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o observations should be documented, reviewed, clear, concise,supported by evidence, identified in terms of specific req,reviewed by the lead auditor with auditees, acknowledged bythe auditees management.

Closing Meeting

o At end of audit before preparing the audit report, a meeting with auditees seniormanagement should be held, to present audit observations clearly. Lead auditorpresents. Keep records of closing meeting

Audit report preparation

o Lead auditor responsible for accuracy and completeness of audit report. Should:

o Lead Auditor to distribute to client. Client then sends it to Senior management.

o Audit completed after submission of report to client

Corrective action/follow-up

o Auditee is responsible for determining and initiating corrective action need tocorrect the cause of non-conformity

o Corrective action and follow-up audits should be completed within time periodagreed to by client and auditees.

o Audit records should be retained according to the agreement with the client,

auditing organization, and auditees, and with an regulatory requirements. Glossary of Audit terms (pg 49-51)

Cost of Quality

o Difference between actual and budgeted costs is variance. A lot-> managementaction

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Origin of Quality cost measurements

o In 50s and 60s companie evaluated and reported quality costs due to:

Products became more complex, customer expectations of products became more sophisticated,

supplier and customer costs expanded,

technical specialists were added to the quality dept to makeimprovements and alternatives presented by quality speciatlists need tobe presented to management in monitory terms

o Quality costs reports are vehicles to 1) determine status of cost control effortsand 2) identify additional opportunities for reducing the cost of quality bysystematic improvements.

o Cost of quality is high (15 to 20% of costs) should catch management attention

o Juran- costs of poor quality avg 15% (vary from 5-35% complexity)for mfg firms;service organization the avg cost is 30% of operating expences (vary 20-40%)

Quality cost categories

o Quality costs all costs associated with company efforts devoted to planingthequality system, efforts to verify quality is obtained, and with failures resultinginadequate systems.

Prevention costs- cost of activities specifically designed to prevent poorquality in products or services

Appraisal costs- costs associated with measuring, evaluating, or auditingproducts or services to assure conformance to quality standards andperformance requirement

Failure costs resulting from product or service not conforming to req orcustomer/user needs. Cost resulting from poor quality; divided intointernal and external

Internal failure costs- occur prior to delivery or shipment ofproduct, or the furnishing of service to customer

External failure costs- occur after deliver or shipment of product,or during or after furnishing of service to customer

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examples of costs is on page 55-56

Optimum Quality Costs

o Mimimum level of total quality costs occurs when the quality of conformance is100%. This model illustrateds that as prevention and appraisals costs inc, thefailure costs will decrease unit an optimum point is reached.

o Earlier Juran depicted that lowest total quality cost point to be at some value less

than 100% good. May be true for some unsophisticated products

o Some say for ever $1 in prevent save $7 in failure costs

o Typical ratios for American companies

o Implementation of preventative measures to control quality often takes time.Appraisal measures are initially undertaken which cause internal failures toincrease but external failures to decrease. However a small inc in preventionsmethods will normally create a large decrease in total quality costs.

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Quality Cost improvement

o Quality goal and objective: position desired among competitors, long-term qualityreputation desired.

o Translate quality goals into quality requirements- outgoing quality levels required,

specific tyope of controls required, special tests requiredo Estimate capability of projects consistent with comp goals.

o And other on pg 59

Quality cost comparison bases

o Quality costs should be related to as many different volume bases as practical.Two or three comparisons are normal.

o Quality costs are normally summarized monthly on a report form similar to thetypical quality cost format on table 3.19 (pg 61). Categorize cost by Quality costcategory (prevention, appraisal, internal, external)

Quality Cost Responsibilities

Advantages of quality cost system

Limitations of Quality cost system

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Other Quality Cost Pitfalls

o Perfectionism in the numbers - precisions in quality cost figures; short time and littlemoney to get estimates that are 85% accurate (ok sometimes for decision making). Ifgo to 95% long time and expensive, which may cause company the initiative to moveforward with considerable total savings.

o Other data pitfalls - presentation to managers should be done in a way thatdiscussion is on the merits of improvement proposals and not on the validity of data

o Inclusion of non-quality costs : management should decide way to define waste. Willonly pure product quality waste be included?

o Implications of reducing quality costs to zero : quality cost presentation shouldrecognize that at times its not realistic or economically to reduce quality costs to zero

o Reducing quality costs but increasing total company costs : may be necessary toensure that a reduction in quality costs will not increase total costs.

o Understatement of quality cost: understate quality by dealing with quality costs onlyin excess of some normal standard. In the prevention approach, emphasis should be

to challenge whether the standard level can be improved.o Inconsistency of measurement: Valid cost comparisons of different time periods

require consistency of categories of reporting and classification of quality costs.

Pareto Analysis of Quality Costs

o Pareto analysis used to analyze quality costs, particularly failure costs.

o Corrective action taken on major defects first

Taguchis Loss Function

o Theoretically a quadratic relations

Taguchi contends as product characteristics deviate from the normal aim, lossesincrease according to a parabolic function

o Equation emphasizes point that a consistent product minimizes the total

loss. Merely attempting to produce a product within spec doesnt prevent loss

Quality Training

Good training is a planned and ordered process where the trainee is guided along apath of learning

Quality engineer involved in departmental development training or training for theentire workforce.

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ISO 9001:2000 in Element 6.2 (Human Resources) requires that personnelperforming work affecting quality shall be competent on the basis of appropriateeducation, skills, and experience.

And organization identifies compentency needs and provide training forpersonnel performing activities affecting quality; evaluate trainingeffectiveness; make employee aware of importance of quality activities; andmaintain appropriate education, exp, training, and qualification records.

Training to reduce Workmanship Defects

o Proper training reduces errors and costs;

o three areas that lead to workmanship defects: lack of skills or training;misunderstanding instructions, carelessness.

o Certify can perform required standards by: 1) prehiring qualification includingeducation and experience, good aptitude and test scores 2)post- hiring trainingincluding a concentrated training program, good grades after completion oftraining and special training for specific tasks.

o Carelessness is usually poor attitude about the job. Training for customer interface

o Element of good training program:

Teach skills that are distinctive to the company

All employees are treated as potential career employees

Regular training is required

Time and money are allocated for training

On the job training: knowledge of products, listening skills, how to handle problems, are offixing customer problem recovery,

Teach new skills: learn business basics, pC skills, math

Use training for strategic changes,

Training not cut when times are hard,

Customer interface level is involved in the training effort

Training is used to teach vision and values

Training needs assessment

o First determine training needs before planning to train

o Use annual employee evaluation as a method to assess the training needs.

o Not employee deficiencies, training dependent on employees.

o Perform a formal Training Needs Analysis (TNA) to assess gaps in performanceand ideal performance. Collect info on:

Current activities and performance; future activities & ideal performance

If gap decide to: provide training, select subject content for training,allocate resources for training, determine number to be trained, amount oftraining to provide, collect info on effectiveness of training.

Three step process

Survelliance- use informal contacts to get subjective ideas oftraining

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Investigation- starts if training programs is on horizon. Datagathering techniques are observation, interviees, questionnaires,records of act., work samples, work studies, psychological tests.

Analysis- detailed analysis of the data collected. Purpose toremove invalid info, group and summarize data, draw conclusions,and prepare a report.

Training Guidelines

o Continuously educate all organization levels in the skill, knowledge, and attitudesneeded for quality work

o Emphasize on teaching skills (ability to cooperate, mutual understanding,working together, and basic social skills)

o Provide continuous learning

o Include all levels of personnel (janitor to president)

Training Principles

o Used to develop increased capability in the workforce

o Continuing process in efforts to acquire new information, attitudes and skills onthe part of the trainee.

o Enhance effectiveness by: 1) express objectives in performance terms 2) learnsshould receive immediate feedback 3) training programs must be audited andvalidated 4) training programs must be adapted to the individual 5) expressmaterial in way that is relevant and related to learner

Training effectiveness

o Costs for training: trainer (workshop, transport, lodging, expenses), employee(salary), temps (take place of employee), Room (+ food), Preparation time(salary), TNA costs (performing TNA workshop)

o Costs of workshop should be counteracted by potential value the org will receivefrom training

o Collect post training projects and productivity improvements.

o Also train to meet ISO standard requirements

o Ways to evaluate training: 1) reaction or smile 2) post test exam of workshop 3)pre-test and post-test

Training deterrants

o Some people are resistant to learning new things.

o Fear of asking question- dont want to look dumb; fear and anxiety are presentdeterrents to learning and can freeze performance and skills.