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Elements and Performance Criteria

  1. Satisfy quality system requirements in daily work
  2. Analyse opportunities for corrective and/or optimisation action
  3. Recommend corrective and/or optimisation actions
  4. Participate in the implementation of recommended actions
  5. Participate in the development of continuous improvement strategies

Required Skills

Required skills

Required skills include

applying problem solving techniques and strategies

applying statistical analysis and statistical sampling procedures

detecting nonconforming products or services in the work area

documenting and reporting information about quality

contributing effectively within a team to recognise and recommend improvements in productivity and quality

implementing and monitoring improved practices and procedures

Required knowledge

Required knowledge includes

specifications for laboratory products and services in the candidates work area

quality requirements associated with the individuals job function andor work area

scientific and technical knowledge underpinning the processes procedures equipment and instrumentation associated with the candidates work tasks and duties

workplace procedures associated with the candidates regular technical duties

sustainable energy principles

relevant health safety and environment requirements

layout of the enterprise divisions and laboratory

organisational structure of the enterprise

lines of communication

role of laboratory services to the enterprise and customers

Specific industry

Additional knowledge requirements may apply for different industry sectors For example

Biomedical sector

ethical requirements dealing with patient confidentiality

animal welfare legislation and codes of practice

guidelines for pretransfusion testing

gene technology regulations for large scale small scale and planned release of genetically manipulated organisms

Evidence Required

The Evidence Guide provides advice on assessment and must be read in conjunction with the performance criteria required skills and knowledge range statement and the Assessment Guidelines for the Training Package

Overview of assessment

Critical aspects for assessment and evidence required to demonstrate competency in this unit

Assessors should ensure that candidates can

use the enterprises quality systems and business goals as a basis for decision making and action

apply all relevant procedures and regulatory requirements to ensure the quality and integrity of the productsservices or data provided

apply and promote sustainable energy principles and work practices

detect nonconforming products or services in the work area

follow enterprise procedures for documenting and reporting information about quality

contribute effectively within a team to recognise and recommend improvements in productivity and quality

apply effective problem solving strategies

implement and monitor improved practices and procedures

Context of and specific resources for assessment

This unit of competency is to be assessed in the workplace or simulated workplace environment

This unit of competency may be assessed with

MSLA Process and interpret data

MSL924001A Process and interpret data

MSLA Obtain representative samples in accordance with sampling plan

MSL954001A Obtain representative samples in accordance with sampling plan

relevant MSL series units of competency

relevant MSL series units of competency

Resources may include

enterprise quality manual and procedures

quality control datarecords

customer complaints and rectifications

candidates supervisors and peers

Method of assessment

The following assessment methods are suggested

review of documentation completed by the candidate as part of regular quality control

feedback from supervisors andor customers regarding quality of productsservices andor data regularly provided by the candidate

observation of the candidates performance and participation in quality improvement teams over time in the workplace

review of reports from quality improvement teams where the candidates role is clearly outlined and verified

verified reports of improvements suggested and implemented by the candidate individually

Those aspects of competency dealing with improvement processes could be assessed by the use of suitable simulations andor a pilot plant andor a range of case studies and scenarios

In all cases practical assessment should be supported by questions to assess essential knowledge and those aspects of competency which are difficult to assess directly

Where applicable reasonable adjustment must be made to work environments and training situations to accommodate ethnicity age gender demographics and disability

Access must be provided to appropriate learning andor assessment support when required

The language literacy and numeracy demands of assessment should not be greater than those required to undertake the unit of competency in a work like environment

This competency in practice

Industry representatives have provided the case studies below to illustrate the practical application of this unit of competency and to show its relevance in a workplace setting

Manufacturing

A quality improvement team at a chemical manufacturing plant was asked to propose a way of minimising the cost of disposing of chromium rich waste Using appropriate techniques the team narrowed the alternatives down to the option of burning the waste stream An experienced technician agreed that this was feasible but suggested that because the waste was petroleum high in chromium the team should consider the environmental implications Subsequent research indicated that the permitted chromium levels in the incinerated air waste stream would not exceed ppm which was less than the air emission standards for the plant The technician analysed samples of the air waste stream and determined that the chromium levels were below the regulatory standards Heshe then supported the teams suggestion

Environmental

The manager of an environmental testing laboratory believed that the team of laboratory technicians relied too much on external direction As a result the manager requested that whenever technicians asked for assistance they should also be ready to suggest a solution to the problem if at all possible This strategy was implemented in a nonthreatening manner and was accepted by the team In time the manager noted that many of the suggestions for solving problems and improving work practices that came from the team were effective and reasonable Their skill in making realistic recommendations came from their familiarity with many of the issues that needed to be considered It became the norm that the laboratory technicians were given public credit for suggesting successful strategies that improved safety productivity and staff morale

Food processing

A company that produces apple juice uses hydrogen peroxide HO to sterilise packaging A mist of atomised HO is sprayed into preformed cartons and later removed with a jet of hot sterile air The laboratory manager was concerned that some batches of product were not sterile after standing at room temperature for several days The cause of the failure in the sterilisation procedure was not apparent and a technical officer was asked to investigate this problem

The technical officer examined each unit operation of juice manufacture and determined that the application of HO was a critical sterilisation point where failure could occur The concentration of HO in the atomiser and in opened containers was unpredictable and several problems were found to contribute to this HO was left in the atomiser for up to several days between packaging runs Containers of HO were not always used sequentially some being opened and then not used for a long time The containers were stored at room temperature after opening and some may have become contaminated with atmospheric particulates that catalyse the breakdown of HO

The recommendations that emerged from the investigation were that

fresh HO should be used at the beginning of each packaging run

only one stock container of HO should be open at any one time and stored chilled with residuals discarded after days

care should be taken to exclude foreign material from the opened vessels of HO and the atomiser

In summary the intolerance of the company to even low incidences of faulty product and the competency of the technical officer to investigate the processing stream resulted in increased product quality without significant cost


Range Statement

The range statement relates to the unit of competency as a whole. It allows for different work environments and situations that may affect performance. Bold italicised wording, if used in the performance criteria, is detailed below. Essential operating conditions that may be present with training and assessment (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) may also be included.

Codes of practice

Where reference is made to industry codes of practice, and/or Australian/international standards, it is expected the latest version will be used

Standards, codes, procedures and/or enterprise requirements

Standards, codes, procedures and/or enterprise requirements may include:

Australian and international standards, such as:

AS ISO 17025-2005 General requirements for the competence of testing and calibration laboratories

AS/NZS ISO 10005:2006 Quality management systems - Guidelines for quality plans

AS/NZS ISO 10012:2004 Measurement management systems - Requirements for measurement processes and measuring equipment

AS/NZS ISO 9000 Set:2008 Quality management systems set

AS 1199 Sampling procedures and tables for inspection by attributes

BS 5750 Quality systems

Australia New Zealand Food Standards (ANZFS) Code

Australian code of good manufacturing practice for medicinal products (GMP)

customer specific requirements/standards

enterprise and customer product specifications

National Association of Testing Authorities (NATA) Accreditation programs requirements

National Health and Medical Research Council (NHMRC) Guidelines

national measurement regulations and guidelines

principles of good laboratory practice (GLP)

quality manuals and procedures

Therapeutic Goods Regulations 1009

Quality control procedures

Quality control procedures may include:

standards imposed by regulatory and licensing bodies

enterprise quality procedures

working to a customer brief or batch card and associated quality procedures

checklists to monitor job progress against agreed time, costs and quality standards

preparation of sampling plans

the use of hold points to evaluate conformance

the use of inspection and test plans to check compliance

Methods for statistical analysis

Methods for statistical analysis may include:

means

median

mode

ranges

standard deviations

statistical sampling procedures

Problem solving techniques

Problem solving techniques may include:

identifying inputs and outputs

sequencing a process

identifying and rectifying a problem step

root cause analysis

implementing preventative strategies

Quality improvement tools and techniques

Quality improvement tools and techniques may include:

run charts, control charts, histograms and scattergrams to present routine quality control data

plan, do, check, act (PDCA)

Ishikawa fishbone diagrams and cause and effect diagrams

logic tree

similarity/difference analysis

Pareto charts and analysis

force field/strength weakness opportunities threats (SWOT) analysis

Sustainable energy principles and work practices

Sustainable energy principles and work practices may include:

examining work practices that use excessive electricity

switching off equipment when not in use

regularly cleaning filters

insulating rooms and buildings to reduce energy use

recycling and reusing materials wherever practicable

minimising process waste

Communication

Communication may involve:

supervisors, managers and quality managers

administrative, laboratory and production personnel

internal/external contractors, customers and suppliers

Reporting

Reporting may include:

verbal responses

data entry into laboratory or enterprise database

brief written reports using enterprise proformas

Quality improvement opportunities

Quality improvement opportunities could include improved:

production processes

hygiene and sanitation procedures

reductions in waste and re-work

laboratory layout and work flow

safety procedures

communication with customers

methods for sampling, testing and recording data

Occupational health and safety (OHS) and environmental management requirements

OHS and environmental management requirements:

all operations must comply with enterprise OHS and environmental management requirements, which may be imposed through state/territory or federal legislation - these requirements must not be compromised at any time

all operations assume the potentially hazardous nature of samples and require standard precautions to be applied

where relevant, users should access and apply current industry understanding of infection control issued by the National Health and Medical Research Council (NHMRC) and State and Territory Departments of Health