MTL - BROCHURE 2018 SINGLE PAGES
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| CASE REPORT - TRAINING<br />
ON SITE STERILISATION TRAINING<br />
PROGRAMME<br />
North West Ireland<br />
Client needs<br />
The client had an extensive requalification<br />
programme for porous load and fluid load<br />
sterilisation processes on site. This programme<br />
required 54 man days per year of requalification effort<br />
as well as production downtime, yet sterilisation<br />
deviations were still an adverse trend on the site.<br />
The client needed to improve confidence and reduce<br />
deviations in the sterilisation processes on site. To<br />
deliver this, a comprehensive up skilling and training<br />
and competency assessment for everyone involved<br />
in the sterilisation process from Operations to QA<br />
Review was required.<br />
What we delivered<br />
Based upon site survey, discussions and analysis<br />
of the current approach we developed a series of<br />
training courses for the site.<br />
Each course developed was site and process specific<br />
so the actual loads, cycle design, autoclaves and site<br />
procedures were used in the training. This included:<br />
• 2 day Operations and QA Course<br />
• 3 day Engineering, Technical and Validation Course<br />
• 1 day additional Thermal and BI Validation<br />
Practices Course for the Validation and QA teams<br />
• Ongoing training support to develop 2 site SME<br />
resources on Sterilisation<br />
Each course was delivered with comprehensive,<br />
indexed course notes based upon actual site<br />
autoclaves and processes.<br />
A common feature of our training courses is that high<br />
quality colour and well indexed course manuals are<br />
delivered that serve as a reference tool in the future.<br />
Detailed competency assessments, ranging from<br />
operations multi choice questionnaire to written<br />
papers for the technical, validation and SME<br />
resource were developed. These demonstrated<br />
learning outcomes and the application knowledge.<br />
Certificates based upon this competency assessment<br />
were awarded.<br />
The results<br />
• Deviations linked to sterilisation processes fell<br />
dramatically<br />
• Operation’s involvement and understanding<br />
of the process identified many improvements<br />
linked to quality assurance as well as efficiency<br />
improvements.<br />
• The training in thermal and biological validation<br />
identified several opportunities for applying latest<br />
best practice and advancement in technology<br />
to simplify the qualification and requalification<br />
processes.<br />
The ROI<br />
Sterilisation related deviations were<br />
significantly reduced which was the<br />
primary objective of the work.<br />
Requalification workload reduced from<br />
54 man days to less than 30 man days<br />
through rationalisation and application<br />
of current best practice for qualification<br />
of sterilisation processes.
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