Quality objectives SOPs availability Storage, indexing, retention of records Legal requirements TNA & related training records/ competency Customer requirement Previous audit findings Quality risk assessment Process approach & implementation (KPIs development and implementation) Knowledge management and understanding Organogram and job description Management of change Infrastructure and working environment Calibration of equipment (where applicable) Identification & traceability Improvement initiatives
Sec B – Common Areas – EMS
Context and interested parties
E Policy – availability awareness E objectives SOPs availability Storage, indexing, retention of records Legal requirements TNA & related training records / competency Previous audit findings Risk assessment and Aspect Impact Analysis Organogram and job description Improvement initiatives Monitoring and Measurement Emergency Preparedness
Sec C - Specific to Deptt – Stores (For example)
Department Specific Requirements – Storage (For example)
The FIFO (First In, First Out) method of inventory management is used? Are all materials placed on specified place, location identification trackable through system? Are required stacking heights and distance from walls maintained? Are required storage conditions being maintained and monitored e.g. temperature, humidity, ventilation e.t.c In general housekeeping is up to the mark? Physical condition of items appears ok? Are physical assessment records for stock available? Are areas specified for handling and segregation of rejected/expired items? Are used parts, junk material / scrap are being discarded properly? Chemicals are clearly labeled and stored away from other materials, any arrangements for spill control? In general housekeeping is up to the mark? (Any other queries may be listed)
Sec D - Process Approach based audit
(Select one or more processes of a department for detailed audit using process approach and risk based thinking)
Check if
Inputs and outputs determined
Process steps described in the form of SOP and / or Process Flow Resources, Responsibilities and Authorities documented Process Control Parameters specified Key Performance Indicators (KPIs) developed, acceptable limits are defined and monitored Risk identified and their controls established as a result of formal risk assessment Process is validated on regular intervals and improvement opportunities identified