BRC Issue 5

Changes per Chapter

1 Senior management commitment and continuous improvement
There are few changes in this section, except for some minor clarifications and
changes to the order of appearance.
2 Hazard and risk management system
Here too the changes are minor. In clause 2.2 the concept of quality has been
added. This means that quality is a factor to consider during risk and hazard
analysis and that it is acceptable to manage quality hazards through prerequisite
programmes.
Another addition is the inclusion of the risk of migration as a potential hazard in
the manufacture and storage of packaging materials, as well as potential for
malicious intervention, reflecting more current potential issues in the
manufacture and use of packaging materials.
3 Product safety and quality management system
The order of the clauses has been changed to reflect the logical order of the
processes. In addition, a new clause has been added to manage suppliers of
services. Management of subcontracting of production (3.5) was always part of
Issue 4, but this addition ensures that both aspects of supply into the site are
adequately controlled.
4 Site Standards
A couple of clauses have been added relating to pest control. Sites that manage
their own pest control program need to have appropriate measures in place to
ensure its effectiveness. All pest control equipment is required to be function. All
employees should be able to recognize and report any signs of pest activity.
Here too there have been minor changes to the order of the clauses. Staff
facilities has been incorporated into section 6 (6.3) as it relates to personnel, and
housekeeping and cleaning has moved from 4.9 to 4.8. Meanwhile, product
contamination control (glass and brittle plastics, sharps and chemical and
biological controls) are now in 4.9.
5 Product and Process Control
Two new clauses catch the eye here: 5.2 Graphic design and artwork control, and
5.8 Incoming Goods.
Graphic design has been added so that sites conducting any pre-print artworkrelated activities are responsible for the artwork and have systems in place to
maintain the integrity of the images. This is in addition to packaging print
controls which are concerned with the printing process.
Incoming goods is a small clause but partly formed by an existing clase from

Issue 4s Transport, Storage and Distribution section, which has been extensively
reviewed and amended for Issue 5.
Storage of all materials and intermediate and finished products (now 5.9) and
dispatch and transport (now 5.10) replace Issue 4s transport storage and
distribution to give adequate emphasis to the roles those two functions play in
maintaining product integrity. There is no overlap with the Storage and
Distribution Standard as the requirements relate only to what occurs on the site.
The requirements for in-line testing and measuring equipment have been
moved and now form part of product inspection, testing and measuring; 5.6;
and control of the equipment used for this is under the revised calibration and
control of measuring and monitoring devices, 5.5.
6 Personnel
As indicated above, the clause on Staff facilities has moved from chapter 4, and
access and movement of personnel has joined with layout and product flow in
section 4 (now 4.5).
Evaluation System
An excellence level has been introduced to foster continuous improvement. The
new classification AA is geared towards sites that have already reached the
Grade A. Sites with less than 5 minor non-conformities can achieve the
excellence level. The maximum possible number of minors of the previous
category A remains unchanged.