Elements and Performance Criteria

The range statement indicates the context for demonstrating competence. This statement is a guide and unless otherwise indicated, items may or may not apply as required by the work context.
- Work is carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements and industrial awards and agreements
- Workplace information may include Standard Operating Procedures (SOPs), specifications, production schedules and instructions, manufacturers' advice, sampling plans
- When applied to the pharmaceutical industry, relevant GMP codes apply and reference to food safety is replaced by GMP
- Sampling requirements include sampling under standard conditions and sampling after processes are adjusted in response to variation or non-conformance
- Sampling typically occurs at a number of points and using a range of techniques
- Maintenance of sample integrity may be achieved by use of appropriate personal protective clothing, clean sampling tools and containers (sterilised tools/containers for aseptic sampling), temperature control and addition of preservatives as required
- Sampling techniques may include sub-sampling
The range statement indicates the context for demonstrating competence. This statement is a guide and unless otherwise indicated, items may or may not apply as required by the work context.
- Work is carried out according to company policies and procedures, regulatory and licensing requirements, legislative requirements and industrial awards and agreements
- Workplace information may include Standard Operating Procedures (SOPs), specifications, production schedules and instructions, manufacturers' advice, sampling plans
- When applied to the pharmaceutical industry, relevant GMP codes apply and reference to food safety is replaced by GMP
- Sampling requirements include sampling under standard conditions and sampling after processes are adjusted in response to variation or non-conformance
- Sampling typically occurs at a number of points and using a range of techniques
- Maintenance of sample integrity may be achieved by use of appropriate personal protective clothing, clean sampling tools and containers (sterilised tools/containers for aseptic sampling), temperature control and addition of preservatives as required
- Sampling techniques may include sub-sampling

The assessment process must address all of the following items of evidence.
Ability to:
1. Access and interpret sampling plan to identify sampling requirements
2. Select, fit and use personal protective clothing and/or equipment
3. Prepare for sampling to ensure required tools, containers and labels are available
4. Follow sampling procedures and the sampling plan to collect samples from the point/s, in the quantities and at the times specified
5. Identify atypical source materials and/or samples and take corrective action. This may involve reporting abnormalities, repeating sample collection and/or following intensive sampling schedules as required
6. Complete sample records according to workplace requirements. This may include labelling samples as required
7. Transfer samples for testing
8. Maintain work area to meet housekeeping standards
May include ability to:
9. Prepare samples according to procedure
Knowledge of:
10. Basic sampling principles. This includes an understanding of the importance of following the sampling plan to obtain representative sampling reflecting characteristics of source material, the sample characteristics and related preservation, handling and storage requirements and the labelling system purpose and requirements
11. Tests to be conducted on samples and related handling and preparation requirements and responsibilities
12. Characteristics of materials sampled and common contaminants and related conditions under which contamination is likely to occur
13. Sampling techniques relevant to samples collected. This may include an understanding of sterilisation methods and procedures
14. The relationship between sampling, testing and production processes. This includes an understanding of different sampling regimes that may apply in response to non-standard conditions or after corrective action is taken to adjust production outputs
15. Procedures and responsibility for reporting and recording sampling information. This may include legislative requirements
May include knowledge of:
16. Procedures for preparing samples
The assessment process must address all of the following items of evidence.
Ability to:
1. Access and interpret sampling plan to identify sampling requirements
2. Select, fit and use personal protective clothing and/or equipment
3. Prepare for sampling to ensure required tools, containers and labels are available
4. Follow sampling procedures and the sampling plan to collect samples from the point/s, in the quantities and at the times specified
5. Identify atypical source materials and/or samples and take corrective action. This may involve reporting abnormalities, repeating sample collection and/or following intensive sampling schedules as required
6. Complete sample records according to workplace requirements. This may include labelling samples as required
7. Transfer samples for testing
8. Maintain work area to meet housekeeping standards
May include ability to:
9. Prepare samples according to procedure
Knowledge of:
10. Basic sampling principles. This includes an understanding of the importance of following the sampling plan to obtain representative sampling reflecting characteristics of source material, the sample characteristics and related preservation, handling and storage requirements and the labelling system purpose and requirements
11. Tests to be conducted on samples and related handling and preparation requirements and responsibilities
12. Characteristics of materials sampled and common contaminants and related conditions under which contamination is likely to occur
13. Sampling techniques relevant to samples collected. This may include an understanding of sterilisation methods and procedures
14. The relationship between sampling, testing and production processes. This includes an understanding of different sampling regimes that may apply in response to non-standard conditions or after corrective action is taken to adjust production outputs
15. Procedures and responsibility for reporting and recording sampling information. This may include legislative requirements
May include knowledge of:
16. Procedures for preparing samples