Required skills

Ability to

locate regulations codes guides and internal company documentation relevant to GMP and productsprocesses used in the work area

participate in change control procedures

apply communication and consultation skills to engage and consult with work areas and personnel affected by change

ensure that related skills and knowledge requirements are addressed by the training system

apply negotiationissue resolution skills

prepare workplace documentation in plain English and suited to purpose and audience

demonstrate and support cooperative work practices within a culturally diverse workforce

Required knowledge

Knowledge of

types of change that come within the scope of change control procedures

change classification procedures and responsibilities

principles of risk management and related procedures

documentary evidence required to support change request

change control procedures roles and responsibilities

workplace documentation including procedures for review authorisation and control of documents

training system including assessment methods and documentation

validation system procedures and responsibilities

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

Assessment may occur in a real or simulated pharmaceutical or complementary medicine manufacturing workplace where the assessment environment provides access to workplace documentation and document management systems related to change control that are typical of commercial manufacturing businesses and meet the requirements of the Therapeutic Goods Act It will also provide a range of commercial manufacturing packaging equipment and activities typically used in a commercial manufacturing environment

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

Evidence of participation in a project team to control change in a work area This includes providing evidence that the candidate

identifies situations requiring change control for a given set of change scenarios

participates in developing a change management plan

develops a documented implementation plan to introduce change into a work area This may be a subset of a larger change management plan

leads the implementation of change in a work area This includes reviewing relevant workplace documentation ensuring that required training occurs consulting with parties affected by change and negotiating any issues raised monitoring and reporting on change and liaising with relevant departments personnel to ensure that authorisation and validation processes occur as required

Context of and specific resources for assessment

Resources for assessment

change request

workplace documentation including procedures relating to change control

real or simulated workplace context

Method of assessment

This unit could be assessed concurrently with other units relating to problem solving and process improvement Examples could be

FDFOPA Apply principles of statistical process control

FDFOP2015A Apply principles of statistical process control

FDFPHA Prepare and review workplace documentation to support Good Manufacturing Practice

FDFPH4001A Prepare and review workplace documentation to support Good Manufacturing Practice

FDFPHA Facilitate and monitor Good Manufacturing Practice

FDFPH4002A Facilitate and monitor Good Manufacturing Practice

FDFPHA Facilitate contamination control

FDFPH4003A Facilitate contamination control

FDFPHA Participate in validation processes

FDFPH4005A Participate in validation processes

MSACMTA Undertake process capability improvements

MSACMT450A Undertake process capability improvements.

Guidance information for assessment

To ensure consistency in ones performance competency should be demonstrated on more than one occasion over a period of time in order to cover a variety of circumstances cases and responsibilities and where possible over a number of assessment activities

Regulations, codes and guides

Change

Change management

Workplace documentation

Authorisation requirements

Change management plan