Control packing operations for pilots and clinical trials
URN: COGPAC8
Business Sectors (Suites): Packaging
Developed by: SDS
Approved on:
31 Mar 2012
Overview
This unit describes the competences required to control a packing operation for a pilot or clinical trial.
To perform competently, you will need to show that you can operate in a range of conditions. You will need to demonstrate therefore that you can deal effectively with the following:
1 checks of the packs (primary, secondary or tertiary), product security and safety
2 procedures relating to legal requirements and quality standards
3 problems associated with documentation, services, area and equipment and faults in production quality
4 documentation or packing instructions, written packing records and computer-based packing records
5 handover procedures
During this work you must take account of the relevant worksite operational requirements, procedures and safe working practices AS THEY APPLY TO YOU.
Performance criteria
You must be able to:
You must be able to:
P1 use the appropriate personal protective equipment (PPE) and/or productspecific equipment/clothing
P2 pack the correct quantity of products to the correct specification
P3 segregate and label correctly materials and packs which do not meet the specification
P4 maintain the required output rates
P5 keep the work area clean, tidy and secure in compliance with procedures
P6 prepare the packs correctly for transfer
P7 identify and deal with problems according to the procedure
P8 complete the required documentation accurately and legibly
P9 maintain the correct operational status when you have taken over responsibility
P10 report the current operational status accurately within the acceptable time limits, at the correct time and place
P11 follow the correct procedures when handing over to and receiving from someone else
Knowledge and Understanding
You need to know and understand:
You must be able to:
K1 which personnel protective equipment (PPE) is appropriate and why
K2 any specialised protective equipment or clothing needed for the product and its use
K3 the critical factors affecting product quality (e.g. temperature, humidity etc.)
K4 any specific product handling requirements and sources of information (e.g. hazard sheets)
K5 how to interpret and identify packing instructions
K6 what are the expected levels of cleanliness for the work area
K7 what is the procedure for dealing with spillages
K8 how to monitor product security/integrity during packing
K9 the procedure for segregating materials and packs
K10 what are the labelling procedures
K11 the rate at which you are expected to work
K12 how to monitor and maintain the levels of materials
K13 how to make adjustments according to the procedure
K14 how to prepare packs for transfer
K15 how to handle and dispose of non-recoverable packs and materials
K16 the procedures for reporting problems
K17 the methods of dealing with problems
K18 what information is to be transferred and in what format
K19 the requirements of the handover procedure (both giving and receiving)
K20 how to maintain product security/integrity during the handover
K21 how to identify and emphasise significant information
K22 the operational quality standards required
Scope/range
Scope Performance
Scope Knowledge
Values
Behaviours
Skills
Glossary
Links To Other NOS
External Links
Version Number
1
Indicative Review Date
31 Mar 2017
Validity
Current
Status
Original
Originating Organisation
Cogent
Original URN
COGPAC8
Relevant Occupations
Engineering and Manufacturing Technologies, Manufacturing Technologies, Plant and Machine Operatives, Process Operatives, Process, Plant and Machine Operatives
SOC Code
Keywords
Packing, packaging, control, pilots, clinical trials