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Evidence Guide: MSL916001 - Develop and maintain laboratory documentation

Student: __________________________________________________

Signature: _________________________________________________

Tips for gathering evidence to demonstrate your skills

The important thing to remember when gathering evidence is that the more evidence the better - that is, the more evidence you gather to demonstrate your skills, the more confident an assessor can be that you have learned the skills not just at one point in time, but are continuing to apply and develop those skills (as opposed to just learning for the test!). Furthermore, one piece of evidence that you collect will not usualy demonstrate all the required criteria for a unit of competency, whereas multiple overlapping pieces of evidence will usually do the trick!

From the Wiki University

 

MSL916001 - Develop and maintain laboratory documentation

What evidence can you provide to prove your understanding of each of the following citeria?

Recognise documentation needs/deficiencies

  1. Evaluate current documentation to identify instances where documentation is needed or deficient
  2. Analyse development opportunities and discuss with appropriate personnel to assess and confirm requirements
Evaluate current documentation to identify instances where documentation is needed or deficient

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Develop/revise documentation

  1. Specify documentation need and set/prioritise objectives
  2. Analyse existing documentation/records in accordance with specified requirements
  3. Develop/amend documentation as a draft in accordance with review requirements
  4. Issue documentation to appropriate personnel for review
  5. Edit documentation to ensure that the initial identified need/deficiency and review requirements are satisfied
  6. Recall superseded documentation and issue new documentation in accordance with document control procedures
Specify documentation need and set/prioritise objectives

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Analyse existing documentation/records in accordance with specified requirements

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Issue documentation to appropriate personnel for review

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Implement and evaluate new laboratory documentation

  1. Brief personnel on new/revised documentation to ensure successful implementation of new procedures
  2. Monitor and evaluate implementation of new/revised documentation and amend documents or provide training, if required
Brief personnel on new/revised documentation to ensure successful implementation of new procedures

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

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

Completed
Date:

Teacher:		 Evidence:

 

 

 

 

 

 

 

Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Evidence Guide

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

Required Skills and Knowledge

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.

Range Statement

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