Inspect Quality of raw material and products within in a Science or technology manufacturing, storage and distribution environment
Overview
This standard is about ensuring that sources and supplies of science or technology based products meet the appropriate quality specification and are safe to use. It involves controlling and monitoring the supply of raw materials and intermediate products in science manufacturing and processing industries. It covers the inspection and checking of items to ensure they meet standard operating requirements and specifications on delivery and prior to use during manufacture or processing.
You will need to be able to check items on arrival and ensure that it conforms to product specifications.
The activity is likely to be undertaken by someone whose work role carries out science quality related work activities. This could include individuals working in scientific laboratories, chemical, energetic materials and biochemical manufacturing process industries.
Performance criteria
You must be able to:
P1 ensure that the supplies conform to internal and external quality specifications.
P2 ensure all checks relating to packaging design and materials are within agreed product specification.
P3 ensure all incoming supplies meet the specified quality criteria.
P4 respond to deficiencies, discrepancies or non-conformance identified in the process of quality checking and auditing.
P5 ensure all batch production deviations (planned or unintended) covering all manufacturing facilities, equipment, operations. distribution, procedures, systems and record keeping should be reported and investigated for corrective and preventative action (CAPA.
P6 ensure accurate records are maintained in line with Good Manufacturing & Good Distribution Practices (GDP) and Good Documentation Practice (GDocP).
P7 ensure all relevant documentation provided by suppliers is complete and accurate in accordance to supply chain procedures.
P8 ensure issues outside your authority are escalated to the appropriates level to ensure expedient action in resolving issues.
P9 monitor and record information in line with internal procedures and supplier auditing requirements.
P10 identify where regular inconsistencies in supplies occur and ensure resolution to these issues.
P11 make recommendations to colleagues and technical staff where failure against specifications suggests that a new source of supply is needed.
P12 make recommendations to colleagues and technical staff regarding the suitability of the criteria used as a measure of acceptance.
Knowledge and Understanding
You need to know and understand:
K1 the policies, guidelines and legislation relating to sources and supply of raw materials relevant to the workplace and products within manufacturing and storage.
K2 your organisation's supply chain assurance guidelines, policies, audit requirements, and how they are applied.
K3 the principles of corrective and a preventative action process (CAPA).
K4 the principles and implementation of GMP, GDP and GDocP.
K5 the types and sources of raw materials, intermediates items and products.
K6 the agreed criteria for acceptance and non-acceptance of supplies required for products.
K7 the critical control points for transport, receipt and acceptance of supplies.
K8 the control and sampling methods appropriate to type and source of supply.
K9 how control and sampling methods used by the business should be applied.
K10 the potential methods, sources and types of product contamination that can be encountered during product transportation and delivery.
K11 how contamination during transportation and delivery can be identified.
K12 the range of checks that can be applied to ensure that delivered is safe.
K13 the recording systems that are in place to record data related to accepted and declined deliveries.
K14 the impact that external audit requirements have upon the acceptance.
K15 the range of data that is used to support external audits.
K16 the requirements for certificates of conformity.