Modification History
Not applicable.
Unit Descriptor
Unit descriptor |
This unit of competency covers the skills and knowledge required to respond to non-conformance within level of authority and consistent with legal requirements within the pharmaceutical sector. |
Application of the Unit
Application of the unit |
This unit can apply to people working in a supervisory or line management production role. They would typically work as part of a team responsible for investigating causes and controls to prevent recurrence of non-conformance. Typical applications of this unit would include responding to deviation and incident reporting results and may include participation in responding to customer complaints, product recalls and audit findings. Responding to non-conformance is typically within the parameters of established policies, plans and procedures. |
Licensing/Regulatory Information
Not applicable.
Pre-Requisites
Prerequisite units |
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Employability Skills Information
Employability skills |
This unit contains employability skills. |
Elements and Performance Criteria Pre-Content
Elements describe the essential outcomes of a unit of competency. |
Performance criteria describe the performance needed to demonstrate achievement of the element. Where bold italicised text is used, further information is detailed in the required skills and knowledge section and the range statement. Assessment of performance is to be consistent with the evidence guide. |
Elements and Performance Criteria
ELEMENT |
PERFORMANCE CRITERIA |
1. Identify non-conformance |
1.1. Workplace systems, reports and operating parameters are monitored to identify non-conformance 1.2. Nature of non-conformance is identified and described 1.3. Corrective and preventative action and reporting procedures appropriate to nature of non-conformance are followed |
2. Identify causes of non-conformance |
2.1. Workplace systems are used to investigate possible causes of non-conformance 2.2. Risk assessment is conducted |
3. Review processes to minimise the risk of recurrence |
3.1. Solutions are identified and assessed to eliminate or minimise the risk of recurrence 3.2. An implementation plan is developed 3.3. Workplace documentation is developed or reviewed to support implementation 3.4. Consultative mechanisms are established and/or reviewed to support continuous improvement and communicate information |
Required Skills and Knowledge
REQUIRED SKILLS AND KNOWLEDGE |
This section describes the skills and knowledge required for this unit. |
Required skills |
Ability to :
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Required knowledge |
Knowledge of :
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Evidence Guide
EVIDENCE GUIDE |
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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. |
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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 including production records and data management systems related to managing non-conformance that are typical of commercial manufacturing businesses and meet the requirements of the Therapeutic Goods Act. It will also provide access to workplace policies and procedures to support the management of non-conformance to meet the requirements of the Therapeutic Goods Act. |
Critical aspects for assessment and evidence required to demonstrate competency in this unit |
Evidence of participation in a team responsible for responding to deviation and non-conformance. This includes providing evidence developed by the candidate to:
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Context of and specific resources for assessment |
Assessors must be satisfied that the person can consistently perform the unit as a whole, including all elements, performance criteria, and required skills and knowledge. A holistic approach should be taken to the assessment. Assessment of this unit would typically involve responding to 'what if' scenarios, answering questions and conducting workplace projects. Resources for assessment
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Method of assessment |
This unit could be assessed concurrently with other units relating to problem solving and process improvement. Examples could be:
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Guidance information for assessment |
To ensure consistency in one's 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. |
Range Statement
RANGE STATEMENT |
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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. |
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Non-conformance |
Non-conformance may be assessed against policies, procedures, specifications and audit requirements |
Implementation plan |
An implementation plan includes but is not limited to:
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Legal requirements |
Legal requirements are those prescribed in the Therapeutic Goods Act and other relevant legislation, regulations and codes (relating to product and markets) |
Systems |
Systems and responsibilities for identifying, investigating and responding to non-conformance can include but are not limited to:
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Unit Sector(s)
Unit sector |
Pharmaceutical manufacturing |
Competency field
Competency field |
Co-requisite units
Co-requisite units |
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