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Evidence Guide: MSL916001A - 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!

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MSL916001A - 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
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Analyse development opportunities and discuss with appropriate personnel to assess and confirm requirements

Completed
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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 Recall superseded documentation and issue new documentation in accordance with document control procedures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
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Analyse existing documentation/records in accordance with specified requirements

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

Completed
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Issue documentation to appropriate personnel for review

Completed
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Evidence:

 

 

 

 

 

 

 

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

Completed
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Evidence:

 

 

 

 

 

 

 

Recall superseded documentation and issue new documentation in accordance with document control procedures

Completed
Date:

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

Completed
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Assessed

Teacher: ___________________________________ Date: _________

Signature: ________________________________________________

Comments:

 

 

 

 

 

 

 

 

Instructions to Assessors

Evidence Guide

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:

analyse, draft and amend enterprise documentation in accordance with specifications

complete documentation in a clear and concise manner that is easily understood by others and in accordance with enterprise requirements/ specifications

recognise problems in systems and documentation

use internal and external information sources efficiently

critically analyse information

prepare documentation that is accurate, free from editorial errors and omissions, and in accordance with requirements

prepare documentation that is easily understood by the intended audience

obtain and include relevant feedback on draft documentation

communicate information and developments in the appropriate manner

complete the preparation and distribution of documents in the given time.

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:

MSL916004A Maintain registration and statutory or legal compliance in work/functional area

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

MSL946001A Implement and monitor OHS and environmental management systems.

Resources may include:

information directories and databases

enterprise documents and procedures.

Method of assessment

The following assessment methods are suggested:

examination of a range of relevant enterprise documentation developed by the candidate

feedback from peers and supervisors that enterprise procedures were followed and that the documentation is accurate and user friendly.

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.

Environmental

A water sample thought to contain cadmium had been logged for analysis. Later that day, the technician designated to perform the analysis advised the laboratory supervisor that the procedures had not yet been revised to suit the newly installed analytical equipment. The supervisor created a draft procedure document for the revised procedure and passed it, with an explanation of the reasons for the change, to the appropriate personnel for authorisation. The draft document was approved and the supervisor issued the revised procedures as a control document. The supervisor notified all relevant personnel of the change, removed the old procedures, replaced it with the new document and entered the change in the document control register.

Food processing

Two senior technicians in the laboratory of a food processing company hazard analysis and critical control points (HACCP) team suggested extensive changes to the way the laboratory functioned so that it better supported the HACCP system. The technicians reviewed the existing HACCP documentation and legislation and revised the laboratory documentation that was relevant to the HACCP system. They also organised in-house training to provide each member of the laboratory team with the knowledge and skills essential for successful implementation of this system. Overall, the adoption of a HACCP plan by the company proceeded with relatively few problems, in part because of the involvement of the laboratory staff and the training provided by the company.

Required Skills and Knowledge

Required skills

Required skills include:

analysing, drafting and amending enterprise documentation in accordance with specifications

completing documentation in a clear and concise manner that is easily understood by others and in accordance with enterprise requirements/ specifications

recognising problems in systems and documentation

using internal and external information sources efficiently

critically analysing information

preparing documentation that is accurate, free from editorial errors and omissions and easily understood by the intended audience

obtaining and including relevant feedback on draft documentation

communicating information and developments in the appropriate manner

completing the preparation and distribution of documents in the given time

Required knowledge

Required knowledge includes:

documentation development and tracking

records management and maintenance

quality systems and continuous improvement

organisational structure, delegations and responsibilities

communication protocols and reporting

scientific, technical and workplace terminology

occupational health and safety (OHS), environmental and other relevant legislative requirements, regulations and codes

enterprise standard operating procedures (SOPs)

technical developments in the sector (current methodologies, ranges and interpretations)

relevant health, safety and environment requirements

the laboratory's business goals and key performance indicators

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 10013-2003 Guidelines for quality management system documentation

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

AS/NZS 2243 Set:2006 Safety in laboratories set

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

AS/NZS ISO 14000 Set:2005 Environmental management standards set

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

Australia New Zealand Food Standards (ANZFS) Code

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

Australian Dangerous Goods Code

gene technology regulations

OHS national standards and codes of practice

principles of good laboratory practice (GLP)

testing procedures and specific method collections for industry sectors:

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

Workplace documentation

Workplace documentation may include:

workplace procedures, SOPs and operating manuals

test procedures

sampling procedures (sampling, preparation, labelling, storage, transport and disposal)

evaluation of materials or products

instructions for equipment installation, commissioning, calibration and maintenance

safety requirements for equipment, materials or products

cleaning, hygiene and personal hygiene requirements

methods for extraction or manufacture of a product

risk evaluation, monitoring or control procedures

compliance/non-compliance reports

quality system and continued improvement processes

incident and accident/injury reports

permits

schematics/work flows/laboratory layouts

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

stock records/inventory

training program contents

waste minimisation and disposal

Items of equipment and systems

Items of equipment and systems may include:

online information systems, databases, record and filing systems

computer equipment

Communication

Communication may be with:

supervisors and managers (laboratory, quality and customer service)

other 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)

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