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

MSL916001 Mapping and Delivery Guide
Develop and maintain laboratory documentation

Version 1.0
Issue Date: May 2024


Qualification -
Unit of Competency MSL916001 - Develop and maintain laboratory documentation
Description
Employability Skills
Learning Outcomes and Application This unit of competency covers the ability to develop and maintain relevant documentation and systems in response to identified information requirements or changes in laboratory policy or external accreditation requirements. It includes the analysis of specialised technical requirements and the development and/or amendment of workplace documents, procedures and record keeping systems using established workplace procedures. Final responsibility for documentation and systems generally rests with professional scientific/medical/engineering staff who have the appropriate signatory status or legal delegation.This unit of competency is applicable to technical officers and laboratory supervisors working in all industry sectors.While no specific licensing or certification requirements apply to this unit at the time of publication, laboratory operations are governed by relevant legislation, regulations and/or external accreditation requirements. Local requirements should be checked.
Duration and Setting X weeks, nominally xx hours, delivered in a classroom/online/blended learning setting.

Judgement of competence must be based on holistic assessment of the evidence. Assessment methods must confirm consistency of performance over time, rather than a single assessment event.

This unit of competency is to be assessed in the workplace or a simulated workplace environment. A simulated workplace environment must reflect realistic operational workplace conditions that cover all aspects of workplace performance, including the environment, task skills, task management skills, contingency management skills and job role environment skills.

Foundation skills are integral to competent performance of the unit and should not be assessed separately.

Assessment processes and techniques must be appropriate to the language, literacy and numeracy requirements of the work being performed and the needs of the candidate.

Knowledge evidence may be collected concurrently with performance evidence or through an independent process, such as workbooks, written assessments or interviews (provided a record is kept in each case).

This unit of competency may be assessed with:

MSL916004 Maintain registration and statutory or legal compliance in work or functional area

MSL936001 Maintain quality system and continuous improvement processes within work or functional area

MSL946001 Implement and monitor WHS and environmental management systems

Holistic assessment methods include:

examination of workplace documentation amended and developed by the candidate

feedback from peers and supervisors that documentation developed by the candidate is accurate and user friendly and that workplace procedures were followed.

Access is required to instruments, equipment, materials, workplace documentation, procedures and specifications associated with this unit, including, but not limited to:

information directories and databases

workplace documents and procedures.

Assessors must satisfy the assessor competency requirements that are in place at the time of the assessment as set by the VET regulator.

The assessor must demonstrate both technical competency and currency.

Technical competence can be demonstrated through:

relevant VET or other qualification/Statement of Attainment AND/OR

relevant workplace experience.

Currency can be demonstrated through:

performing the competency being assessed as part of current employment OR

having consulted with a laboratory about performing the competency being assessed within the last twelve months.
Prerequisites/co-requisites
Competency Field Communication/organisation
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: Recognise documentation needs/deficiencies
  • Evaluate current documentation to identify instances where documentation is needed or deficient
  • Analyse development opportunities and discuss with appropriate personnel to assess and confirm requirements
       
Element: Develop/revise documentation
  • Specify documentation need and set/prioritise objectives
  • Analyse existing documentation/records in accordance with specified requirements
  • Develop/amend documentation as a draft in accordance with review requirements
  • Issue documentation to appropriate personnel for review
  • Edit documentation to ensure that the initial identified need/deficiency and review requirements are satisfied
  • Recall superseded documentation and issue new documentation in accordance with document control procedures
       
Element: Implement and evaluate new laboratory documentation
  • Brief personnel on new/revised documentation to ensure successful implementation of new procedures
  • Monitor and evaluate implementation of new/revised documentation and amend documents or provide training, if required
       


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.

Elements describe the essential outcomes.

Performance criteria describe the performance needed to demonstrate achievement of the element.

1

Recognise documentation needs/deficiencies

1.1

Evaluate current documentation to identify instances where documentation is needed or deficient

1.2

Analyse development opportunities and discuss with appropriate personnel to assess and confirm requirements

2

Develop/revise documentation

2.1

Specify documentation need and set/prioritise objectives

2.2

Analyse existing documentation/records in accordance with specified requirements

2.3

Develop/amend documentation as a draft in accordance with review requirements

2.4

Issue documentation to appropriate personnel for review

2.5

Edit documentation to ensure that the initial identified need/deficiency and review requirements are satisfied

2.6

Recall superseded documentation and issue new documentation in accordance with document control procedures

3

Implement and evaluate new laboratory documentation

3.1

Brief personnel on new/revised documentation to ensure successful implementation of new procedures

3.2

Monitor and evaluate implementation of new/revised documentation and amend documents or provide training, if required

Evidence of competence in this unit must satisfy all of the requirements of the elements and performance criteria, and include demonstration of:

recognising problems in workplace documentation and systems

analysing, developing and maintaining workplace documentation and systems in response to identified information requirements or changes in laboratory policy or external accreditation requirements

developing and amending workplace documents and systems using established workplace procedures

producing documentation that is accurate and meets specifications, free from editorial errors and omissions, and understood by others

using internal and external information sources efficiently

critically analysing information

obtaining and incorporating relevant feedback on draft documentation

communicating information and developments effectively

completing the preparation and distribution of documentation in the given timeframe.

Must provide evidence that demonstrates knowledge of:

the laboratory's business goals, key performance indicators (KPIs), organisational structure, delegations and responsibilities

how work health and safety (WHS), environmental, registration/accreditation and other legislative requirements, regulations and codes govern laboratory documentation

standard operating procedures (SOPs) relevant to the laboratory’s operations and scope of testing

scientific, technical and workplace terminology; and technical developments in the sector (such as current methodologies, ranges and interpretations)

workplace procedures for developing/amending and tracking documentation; records management and maintenance

workplace communication protocols and reporting.

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.

Elements describe the essential outcomes.

Performance criteria describe the performance needed to demonstrate achievement of the element.

1

Recognise documentation needs/deficiencies

1.1

Evaluate current documentation to identify instances where documentation is needed or deficient

1.2

Analyse development opportunities and discuss with appropriate personnel to assess and confirm requirements

2

Develop/revise documentation

2.1

Specify documentation need and set/prioritise objectives

2.2

Analyse existing documentation/records in accordance with specified requirements

2.3

Develop/amend documentation as a draft in accordance with review requirements

2.4

Issue documentation to appropriate personnel for review

2.5

Edit documentation to ensure that the initial identified need/deficiency and review requirements are satisfied

2.6

Recall superseded documentation and issue new documentation in accordance with document control procedures

3

Implement and evaluate new laboratory documentation

3.1

Brief personnel on new/revised documentation to ensure successful implementation of new procedures

3.2

Monitor and evaluate implementation of new/revised documentation and amend documents or provide training, if required

This field allows for different work environments and conditions that may affect performance. Essential operating conditions that may be present (depending on the work situation, needs of the candidate, accessibility of the item, and local industry and regional contexts) are included.

Standards, codes, procedures and/or workplace requirements

Standards, codes, procedures and/or workplace requirements include the latest version of one or more of:

Australian and international standards covering the competence of testing and calibration laboratories, laboratory safety, and quality and environmental management

work health and safety (WHS) national standards and codes of practice

registration/licensing and/or National Association of Testing Authorities (NATA) accreditation requirements

codes, guidelines, procedures and specific method collections for industry sectors such as:

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

Australian code of good manufacturing practice for medicinal products (GMP), principles of good laboratory practice (GLP)

Australia New Zealand Food Standards (ANZFS) Code

Australian Dangerous Goods Code

gene technology regulations

Workplace documentation

Workplace documentation includes one or more of:

instructions to comply with new legislation, standards, guidelines, codes and permits

plans covering management of laboratory services, quality, environment, training and maintenance

workplace procedures; standard operating procedures (SOPs) and operating manuals; instructions for equipment installation, commissioning, calibration and maintenance; and waste minimisation and disposal

safety requirements for equipment, materials or products; risk evaluation, monitoring or control procedures; and incident and accident/injury reports

test procedures, sampling procedures (sampling, preparation, labelling, storage, transport and disposal), methods for extraction or manufacture of a product, and procedures for evaluation of materials or products

compliance/non-compliance reports, quality system and continued improvement processes

cleaning, hygiene and personal hygiene requirements

schematics/workflows/laboratory layouts

stock records/inventory

training program contents

Record keeping systems

Record keeping systems include:

online information systems, databases, record and filing systems

Personnel

Personnel include one or more of:

supervisors and managers (laboratory, quality and customer service), and laboratory or production personnel

members of the public, customers and suppliers

external auditors, regulation and licensing/accreditation authorities, such as National Association of Testing Authorities (NATA), if within limits of responsibility and authority

WHS and environmental management requirements

WHS and environmental management requirements include:

· complying with WHS and environmental management requirements at all times, which may be imposed through state/territory or federal legislation. These requirements must not be compromised at any time

· applying standard precautions relating to the potentially hazardous nature of samples

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

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
Evaluate current documentation to identify instances where documentation is needed or deficient 
Analyse development opportunities and discuss with appropriate personnel to assess and confirm requirements 
Specify documentation need and set/prioritise objectives 
Analyse existing documentation/records in accordance with specified requirements 
Develop/amend documentation as a draft in accordance with review requirements 
Issue documentation to appropriate personnel for review 
Edit documentation to ensure that the initial identified need/deficiency and review requirements are satisfied 
Recall superseded documentation and issue new documentation in accordance with document control procedures 
Brief personnel on new/revised documentation to ensure successful implementation of new procedures 
Monitor and evaluate implementation of new/revised documentation and amend documents or provide training, if required 

Forms

Assessment Cover Sheet

MSL916001 - Develop and maintain laboratory documentation
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

MSL916001 - Develop and maintain laboratory documentation

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: