Facilities Auditing
At SSE we can provide a full Facility Audit of your premises, be it a Manufacturing Facility or a Non- Manufacturing Office Block. Our team will work work with you, surveying your premises to provide you with a detailed summary of recommendations and cost effective improvements that ensure your building is safe, clean, productive and compliant.
What is Audited?
- Relevant Procedures.
- Building Aesthetics.
- Cleanliness & Housekeeping.
- Personnel Behaviour.
- Overall effective Contamination Control Practices & Methods used.
Audit Reporting & Training
A detailed written and photographic Report outlining observations, suggestions and recommendations as to how policies and procedures can be improved will be submitted to the client on completion of the Audit.
Cleanroom Auditing?
We also provide a Cleanroom Auditing Service performed by our qualified Auditors and experienced Microbiologists. This service ensures a high standard of GMP is adhered to on an on-going basis and prepares our clients for Regulatory Body Audits such as FDA, HPRA and ISO.
What is Audited?
- Level of GMP within the Cleanroom & Supporting Areas.
- Material Transfer Practices.
- Personnel Behaviour.
- Relevant Procedures.
- Building Aesthetics.
- Cleanliness & Housekeeping.
- Overall effective Contamination Control Practices & Methods used.
Why Cleanroom Auditing?
Regular Cleanroom Auditing is vital to the ongoing development and high standards guarantee of any Cleanroom. Here are just some reasons why Cleanroom Auditing is a necessity:
- Issues that may arise within the Cleanroom.
- Experienced External Advice.
- Ensures a high standard of GMP is adhered to.
- Improving the standards of the Cleanroom and personnel awareness.
- Support corrective / preventive action process.
- Provide objective evidence through a written and photographic report.
- Preparation for Regulatory Body Audits such as FDA, HPRA, ISO, with emphasis on having clients Audit Ready at all times.
- Advise on changes in policies and procedures where necessary.
Training
A detailed written and photographic Report outlining observations, suggestions and recommendations as to how policies and procedures can be improved will be submitted to the client on completion of the Audit. Any suggestions or changes taken on board by the client can then be rolled out as part of a specific Training Programme delivered by SSE.
Very often a Cleanroom Audit is performed in order to examine specific problems or issues within the Cleanroom Environment, for example,current Cleanroom Processes or Methods, Personable Behaviours and Environmental Monitoring Trends.
All Training Programmes are delivered specific to the client’s requirements based on the results of the Cleanroom Audit.
A follow up Audit is performed after the Training has been complete in order to review improvements in Contamination Control Practices and to offer further guidance and support where required.