624
27.10 Internal and External Systems Audits
Systems audits are basically a series of inspections and probes that are regularly
conducted on a processing unit to ascertain its levels of compliance to acclaimed
systems in use (Mtewa and Mtewa 2017). If a manufacturer indicates that they have
quality assurance systems in place, these systems have to be assessed and recommendations for improvement made. Internal audits are conducted by trained members of the facility while external ones are conducted by other inspectorates from
outside the facility. These must be well planned across the year and be sure to cover
all aspects of systems at the facility (Primus Lab. 2015). They should be designed in
a way that aims at auditing systems as opposed to auditing individuals. Audits provoke the traceability of records and documents that the facility indicates to have and
must be found for every item sought (WHO 2008).
27.11 Product Specifications and Conformance
All functional foods that are being manufactured should have clear indicators to
acceptability or rejection. These can be set within the facility but usually, they are
derived from national or international guidelines and specifications (US FDA 2017).
For functional foods, the WHO sets its own standards although regional bodies of
the European Union, African Union, SADC or other blocks set their own customized standards for their won markets (Mtewa and Mtewa 2017). Specifications are
basically values that mark a range of test results that will be accepted by a market or
a regulator, with, at most times, an average value as a target. For instance, one paste
product may be accepted at vitamin D 3 level of 500 μg/g as a target with a minimum
allowable value of 450 μg/g and a maximum allowable value of 550 μg/g. During
production, performance of the products should always be watched by a team of
trained personnel so that appropriate interventions should be timely made.
27.11.1 Laboratory Tests and Validation
Laboratory tests should be carried out only by qualified and trained staff. Minimum
standards of personnel that can conduct the tests should be clearly stated and matching what is actually on the ground. Validated test protocols should be in place (Vu
et al. 2014). Validation of test results can be done using standards as well as by collaborating with a second and a third independent laboratory that should produce
statistically comparable results (Catsambas et al. 2002). All test results must be
entered as raw data into a laboratory book or computer data sheet without a possibility of a non-verifiable cancellation. If in a book, they should be entered in ink, with
dates, signatures and details of the technician who conducted the tests. Similar
A. G. Mtewa et al.
27.10 Internal and External Systems Audits
Systems audits are basically a series of inspections and probes that are regularly
conducted on a processing unit to ascertain its levels of compliance to acclaimed
systems in use (Mtewa and Mtewa 2017). If a manufacturer indicates that they have
quality assurance systems in place, these systems have to be assessed and recommendations for improvement made. Internal audits are conducted by trained members of the facility while external ones are conducted by other inspectorates from
outside the facility. These must be well planned across the year and be sure to cover
all aspects of systems at the facility (Primus Lab. 2015). They should be designed in
a way that aims at auditing systems as opposed to auditing individuals. Audits provoke the traceability of records and documents that the facility indicates to have and
must be found for every item sought (WHO 2008).
27.11 Product Specifications and Conformance
All functional foods that are being manufactured should have clear indicators to
acceptability or rejection. These can be set within the facility but usually, they are
derived from national or international guidelines and specifications (US FDA 2017).
For functional foods, the WHO sets its own standards although regional bodies of
the European Union, African Union, SADC or other blocks set their own customized standards for their won markets (Mtewa and Mtewa 2017). Specifications are
basically values that mark a range of test results that will be accepted by a market or
a regulator, with, at most times, an average value as a target. For instance, one paste
product may be accepted at vitamin D 3 level of 500 μg/g as a target with a minimum
allowable value of 450 μg/g and a maximum allowable value of 550 μg/g. During
production, performance of the products should always be watched by a team of
trained personnel so that appropriate interventions should be timely made.
27.11.1 Laboratory Tests and Validation
Laboratory tests should be carried out only by qualified and trained staff. Minimum
standards of personnel that can conduct the tests should be clearly stated and matching what is actually on the ground. Validated test protocols should be in place (Vu
et al. 2014). Validation of test results can be done using standards as well as by collaborating with a second and a third independent laboratory that should produce
statistically comparable results (Catsambas et al. 2002). All test results must be
entered as raw data into a laboratory book or computer data sheet without a possibility of a non-verifiable cancellation. If in a book, they should be entered in ink, with
dates, signatures and details of the technician who conducted the tests. Similar
A. G. Mtewa et al.