20645_Scapa_AR_160504
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STRATEGIC REPORT<br />
Risk Accountable Executive Key controls and mitigating factors Risk movement<br />
ICT system infrastructure<br />
ICT systems and infrastructure failure<br />
and/or interruption<br />
Impact<br />
> > Significant disruption to direct<br />
manufacturing and support<br />
processes<br />
Graham Hardcastle<br />
Group Finance Director<br />
> > Group and site based business continuity<br />
and disaster recovery processes in place<br />
> > Annual test of disaster recovery for core systems<br />
> > Multi-site and remote device back-up of<br />
electronic data<br />
> > Fallover and standby solutions built into<br />
system architecture for core systems<br />
providing additional resilience<br />
> > Security and segregation built into system<br />
architecture for e-commerce systems to ensure<br />
minimum exposure from transactions<br />
> > We have implemented a rigorous IT governance<br />
model (covering IT Service Management and IT<br />
Portfolio Management), in line with industry best<br />
practice, to provide enhanced assurance for<br />
both our existing IT services and the delivery of<br />
new solutions<br />
REGULATORY AND COMPLIANCE<br />
Product quality<br />
Products are not up to the required<br />
quality and health and safety<br />
standards<br />
Impact<br />
> > Poor financial performance due to<br />
customer returns, product liability<br />
claims, ultimately affecting customer<br />
trust in <strong>Scapa</strong> as a supplier<br />
Joe Davin<br />
Group President,<br />
Healthcare<br />
Kären Olson<br />
Group President,<br />
Industrial<br />
> > Third party International Quality Systems<br />
accreditation:<br />
◊ Ashton, Valence, Ghislarengo and Renfrew<br />
are third party accredited to TS 16949 and<br />
ISO 9001. Ashton and Valence are also<br />
accredited to ISO 14001<br />
◊ Dunstable, Inglewood, Knoxville and Windsor<br />
are accredited to ISO 13485 and ISO 9001<br />
◊ Rorschach, Syracuse and Seoul are<br />
accredited to ISO 9001<br />
> > Internal quality audit processes are in<br />
place with issue resolution tracking<br />
> > Known problems have been addressed with<br />
rigorous root cause analysis and corrective<br />
action to ensure that they do not reoccur<br />
> > Customer quality requirements are<br />
clearly identified<br />
> > In-process and final product quality checks<br />
are performed to ensure compliance<br />
> > Inglewood, Knoxville and Renfrew are registered<br />
as medical device manufacturers under<br />
21CFR820 with oversight from US<br />
Food and Drug Administration (FDA)<br />
> > Recall insurance is in place for Healthcare<br />
and Automotive<br />
Risk remains the same<br />
Risk increases<br />
Risk decreases<br />
17<br />
ANNUAL REPORT AND ACCOUNTS 2016 SCAPA GROUP PLC
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