• MSL936001A - Maintain quality system and continuous improvement processes within work/functional area

Unit of Competency Mapping – Information for Teachers/Assessors – Information for Learners

MSL936001A Mapping and Delivery Guide
Maintain quality system and continuous improvement processes within work/functional area

Version 1.0
Issue Date: March 2024


Qualification -
Unit of Competency MSL936001A - Maintain quality system and continuous improvement processes within work/functional area
Description This unit of competency covers responsibility for the day-to-day operation of the work/functional area and ensuring that quality system requirements are met and that continuous improvements are initiated.
Employability Skills This unit contains employability skills.
Learning Outcomes and Application This unit of competency is applicable to senior technical officers and laboratory supervisors working in all industry sectors. Quality audits and evaluations for the work area may be undertaken as an individual or as part of a team under broad direction from scientists/medical staff/engineers. Industry representatives have provided case studies to illustrate the practical application of this unit of competency and to show its relevance in a workplace setting. These can be found at the end of this unit of competency under the section 'This competency in practice'.
Duration and Setting X weeks, nominally xx hours, delivered in a classroom/online/blended learning setting.
Prerequisites/co-requisites
Competency Field
Development and validation strategy and guide for assessors and learners Student Learning Resources Handouts
Activities
Slides
PPT
Assessment 1 Assessment 2 Assessment 3 Assessment 4
Elements of Competency Performance Criteria              
Element: Develop and maintain quality framework within work area
  • Distribute and explain information about the enterprise's quality system to personnel
  • Encourage personnel to participate in improvement processes and to assume responsibility and authority
  • Allocate responsibilities for quality within work area in accordance with quality system
  • Provide coaching and mentoring to ensure that personnel are able to meet their responsibilities and quality requirements
       
Element: Maintain quality documentation
  • Identify required quality documentation, including records of improvement plans and initiatives
  • Prepare and maintain quality documentation and keep accurate data records
  • Maintain document control system for work area
  • Contribute to the development and revision of quality manuals and work instructions for the work area
  • Develop and implement inspection and test plans for quality controlled products
       
Element: Provide training in quality systems and improvement processes
  • Analyse roles, duties and current competency of relevant personnel
  • Identify training needs in relation to quality system and continuous improvement processes
  • Identify opportunities for skills development and/or training programs to meet needs
  • Initiate and monitor training and skills development programs
  • Maintain accurate training records
       
Element: Optimise and report performance
  • Review performance outcomes to identify ways in which planning and operations could be improved
  • Enhance customer service through the use of quality improvement techniques and processes
  • Adjust plans and communicate these to personnel involved in their development and implementation
       
Element: Evaluate relevant components of quality system
  • Undertake regular audits of components of the quality system that relate to the work area
  • Implement improvements in the quality system in accordance with own level of responsibility and workplace procedures
       


Evidence Required

List the assessment methods to be used and the context and resources required for assessment. Copy and paste the relevant sections from the evidence guide below and then re-write these in plain English.

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:

implement and monitor defined quality system requirements and initiate continuous improvements within the work area

apply effective problem identification and problem solving techniques

strengthen customer service through a focus on continuous improvement

implement, monitor and evaluate quality systems in the work area

initiate quality processes to enhance the quality of performance of individuals and teams in the work area

gain commitment of individuals/teams to quality principles and practices

implement effective communication strategies

encourage ideas and feedback from team members when developing and refining techniques and processes

analyse training needs and implement training programs

prepare and maintain quality and audit documentation.

Context of and specific resources for assessment

This unit of competency should be assessed in a laboratory environment that either meets Australian standards for working laboratories or is accredited by NATA or the Royal College of Pathology, as appropriate.Competency in this unit should be assessed over a sufficient period of time to enable the candidate to initiate and implement improvements.

This unit of competency may be assessed with:

MSL915001A Provide information to customers.

Resources may include:

quality manuals and documentation

quality tools, such as Pareto charts, strengths, weakness, opportunities, threats (SWOT) analysis and plan, do, check, act (PDCA)

quality and customer data.

Method of assessment

The following assessment methods are suggested:

observation of the candidate leading a quality improvement team

review of verified reports of improvement initiatives and/or projects conducted by the candidate

feedback from peers, team members, supervisors, quality manager and customers

review of quality documentation prepared and maintained by the candidate

review of training places prepared by the candidate for personnel in the work area

review of audit processes and outcomes generated by the candidate

questions to assess underpinning knowledge of procedures and contingency management.

In all cases, practical assessment should be supported by questions to assess underpinning 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 and/or 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

The laboratory supervisor with a pharmaceutical company had participated in the production of a company wide quality manual. This manual was distributed to the various work teams and an induction program for all workers was undertaken to familiarise them with the demands of the quality system. A transient, sharp improvement in laboratory operations was observed after which the quality metrics fell (although not to pre-quality system levels). The supervisor investigated this phenomenon and found that many of the analytical specifications determined by the company were detailed in the quality manual and nowhere else. Put simply, after an initial period during which laboratory personnel consulted the manual for guidance, there was a tendency for the personnel to rely more on their memories and less on the manual. The supervisor made it clear to personnel that 'guessing' procedures and methodologies was unacceptable. If they were uncertain of something they must consult the manual. Awareness of this problem allowed the supervisor to be more vigilant in monitoring laboratory operations and personnel eventually developed the habit of referring to the manual as required. A subsequent review of the manual went smoothly and efficiently. The staff were familiar with the manual's strengths and shortcomings and had made annotations for improvements that were readily incorporated during the review.

Environmental

Collection of botanical specimens for research purposes required personnel to record data at the time of collection in a prescribed format. A quality audit conducted by the laboratory supervisor indicated that some documentation was incomplete. The supervisor also found that sometimes documentation was completed later, from memory, rather than in the field. The supervisor met with the collectors involved, reinforced the enterprise protocols, explained the importance of diligent record keeping in achieving valid research outcomes and gained a renewed commitment to quality from the personnel. Subsequent quality audits indicated that the personnel had met their commitment and the research work was no longer jeopardised.

Food processing

The laboratory supervisor of a food processing company had noted over recent years that the requests of some customers were virtually impossible to fulfil. For example, one customer wanted a bleached flour which had not undergone any chemical treatment or adulteration for a particular market niche. Another customer wanted analytical results within an unrealistic timeframe. While none of these requests had caused serious friction between the company and its customers, the supervisor decided to take a proactive stance to address the not altogether unreasonable ignorance of some customers. After consulting with the laboratory manager, the supervisor invited all customers to tour the laboratory, during which the aims and limitations of the analytical procedures were explained. The tour gave customers the opportunity to assess their demands of the company and generate more realistic ideas for modifying the company's products to suit their needs. The outcomes of this exercise were that company-customer relations were improved, the future expectations of some customers were more practical and the company's ongoing program of product improvement was facilitated by customer input.


Submission Requirements

List each assessment task's title, type (eg project, observation/demonstration, essay, assignment, checklist) and due date here

Assessment task 1: [title]      Due date:

(add new lines for each of the assessment tasks)


Assessment Tasks

Copy and paste from the following data to produce each assessment task. Write these in plain English and spell out how, when and where the task is to be carried out, under what conditions, and what resources are needed. Include guidelines about how well the candidate has to perform a task for it to be judged satisfactory.

Required skills

Required skills include:

implementing and monitoring defined quality system requirements

initiating continuous improvements within the work area

applying effective problem identification and problem solving techniques

strengthening customer service through a focus on continuous improvement

implementing, monitoring and evaluating quality systems

gaining commitment of individuals/teams to quality principles and practices

implementing effective communication strategies

encouraging ideas and feedback from team members when developing and refining techniques and processes

analysing training needs and implementing training programs

preparing and maintaining quality and audit documentation

Required knowledge

Required knowledge includes:

communication/reporting protocols

continuous improvement principles

enterprise business goals and key performance indicators

enterprise information systems management

enterprise organisational structure, delegations and responsibilities

policy and procedure development processes

relevant health, safety and environment requirements

relevant national and international quality standards and protocols

standard operating procedures (SOPs) for the technical work performed in work area

the enterprise quality system

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 1199 Sampling procedures and tables for inspection by attributes

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 ISO 10013-2003 Guidelines for quality management system documentation

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

AS 1199 Sampling procedures and tables for inspection by attributes

Association of Analytical Communities International (AOAC International) Official Methods of Analysis

Australia New Zealand Food Standards (ANZFS) Code

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

BS 5750 Quality systems

Codex Alimentarius standards

customer specific requirements/standards

enterprise and customer product specifications

hazard analysis and critical control points (HACCP) principles

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 audits

Quality audits may include:

regular checks of laboratory procedures

daily and weekly checks of specimen reception, instrumentation and results for control and standard samples to identify non-conformance and problem areas

maintenance of appropriate certified reference materials (CRMs)

participation in external quality assurance programs

Communication

Communication may involve:

supervisors, managers and quality managers

laboratory and production personnel

customers and suppliers

auditors

Reporting

Reporting may include:

verbal responses

data entry into laboratory or enterprise databases

written reports

Documentation

Documentation may include:

sampling plans

enterprise quality manual

quality (certification or registration) requirements

audit documents

performance plans and reports

training records and/or plans

workplace procedures relating to occupational health and safety (OHS), equal opportunity (EO) and environmental legislative requirements

industrial awards and enterprise agreements

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

Copy and paste from the following performance criteria to create an observation checklist for each task. When you have finished writing your assessment tool every one of these must have been addressed, preferably several times in a variety of contexts. To ensure this occurs download the assessment matrix for the unit; enter each assessment task as a column header and place check marks against each performance criteria that task addresses.

Observation Checklist

Tasks to be observed according to workplace/college/TAFE policy and procedures, relevant legislation and Codes of Practice Yes No Comments/feedback
Distribute and explain information about the enterprise's quality system to personnel 
Encourage personnel to participate in improvement processes and to assume responsibility and authority 
Allocate responsibilities for quality within work area in accordance with quality system 
Provide coaching and mentoring to ensure that personnel are able to meet their responsibilities and quality requirements 
Identify required quality documentation, including records of improvement plans and initiatives 
Prepare and maintain quality documentation and keep accurate data records 
Maintain document control system for work area 
Contribute to the development and revision of quality manuals and work instructions for the work area 
Develop and implement inspection and test plans for quality controlled products 
Analyse roles, duties and current competency of relevant personnel 
Identify training needs in relation to quality system and continuous improvement processes 
Identify opportunities for skills development and/or training programs to meet needs 
Initiate and monitor training and skills development programs 
Maintain accurate training records 
Review performance outcomes to identify ways in which planning and operations could be improved 
Enhance customer service through the use of quality improvement techniques and processes 
Adjust plans and communicate these to personnel involved in their development and implementation 
Undertake regular audits of components of the quality system that relate to the work area 
Implement improvements in the quality system in accordance with own level of responsibility and workplace procedures 

Forms

Assessment Cover Sheet

MSL936001A - Maintain quality system and continuous improvement processes within work/functional area
Assessment task 1: [title]

Student name:

Student ID:

I declare that the assessment tasks submitted for this unit are my own work.

Student signature:

Result: Competent Not yet competent

Feedback to student

 

 

 

 

 

 

 

 

Assessor name:

Signature:

Date:


Assessment Record Sheet

MSL936001A - Maintain quality system and continuous improvement processes within work/functional area

Student name:

Student ID:

Assessment task 1: [title] Result: Competent Not yet competent

(add lines for each task)

Feedback to student:

 

 

 

 

 

 

 

 

Overall assessment result: Competent Not yet competent

Assessor name:

Signature:

Date:

Student signature:

Date: