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Elements and Performance Criteria

1. Prepare for sampling
   • Sampling requirements are identified inaccordance with the sampling plan
   • Sampling equipment, containers and labels areprepared
2. Collect samples
   • Samples are collected according to samplingprocedures and the requirements of the sampling plan
   • Samples are handled and prepared to preservesample and source integrity
   • Defects or abnormalities in source materialand/or sample are identified and reported
   • Sample information is recorded according toworkplace sample recording requirements
   • The workplace meets housekeeping standards

Required Skills

Not applicable

Evidence Required

The assessment process must address all of the following items of evidence

Ability to

Access and interpret sampling plan to identify sampling requirements

Select fit and use personal protective clothing andor equipment

Prepare for sampling to ensure required tools containers and labels are available

Follow sampling procedures and the sampling plan to collect samples from the points in the quantities and at the times specified

Identify atypical source materials andor samples and take corrective action This may involve reporting abnormalities repeating sample collection andor following intensive sampling schedules as required

Complete sample records according to workplace requirements This may include labelling samples as required

Transfer samples for testing

Maintain work area to meet housekeeping standards

May include ability to

Prepare samples according to procedure

Knowledge of

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

Tests to be conducted on samples and related handling and preparation requirements and responsibilities

Characteristics of materials sampled and common contaminants and related conditions under which contamination is likely to occur

Sampling techniques relevant to samples collected This may include an understanding of sterilisation methods and procedures

The relationship between sampling testing and production processes This includes an understanding of different sampling regimes that may apply in response to nonstandard conditions or after corrective action is taken to adjust production outputs

Procedures and responsibility for reporting and recording sampling information This may include legislative requirements

May include knowledge of

Procedures for preparing samples

The assessment process must address all of the following items of evidence

Ability to

Access and interpret sampling plan to identify sampling requirements

Select fit and use personal protective clothing andor equipment

Prepare for sampling to ensure required tools containers and labels are available

Follow sampling procedures and the sampling plan to collect samples from the points in the quantities and at the times specified

Identify atypical source materials andor samples and take corrective action This may involve reporting abnormalities repeating sample collection andor following intensive sampling schedules as required

Complete sample records according to workplace requirements This may include labelling samples as required

Transfer samples for testing

Maintain work area to meet housekeeping standards

May include ability to

Prepare samples according to procedure

Knowledge of

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

Tests to be conducted on samples and related handling and preparation requirements and responsibilities

Characteristics of materials sampled and common contaminants and related conditions under which contamination is likely to occur

Sampling techniques relevant to samples collected This may include an understanding of sterilisation methods and procedures

The relationship between sampling testing and production processes This includes an understanding of different sampling regimes that may apply in response to nonstandard conditions or after corrective action is taken to adjust production outputs

Procedures and responsibility for reporting and recording sampling information This may include legislative requirements

May include knowledge of

Procedures for preparing samples

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Range Statement

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

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