Title Page
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Audit date :
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Audit reference :
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Auditor :
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Auditee :
Mandatory Audit Questions
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Are procedures being audited meeting the requirements of the where applicable e.g., ISO 9001:2015 and customer-specific codes of practise?
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Are documents accessible and readily available on the master register?
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Are documents in use the correct revisions?
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Have the relevant staff been trained on these documents?
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Are training records up-to-date with the current documents?
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Previous Audit Reviewed
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Any NC Raised in Previous Audit Closed
Audit Specific Questions
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Has the organisation determined the risks and opportunities to be addressed
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Evidence :
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Has the risks and opportunities considered the context of your organization & any interested parties
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Evidence :
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Has risk identification methodology been assigned – is it realistic
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Evidence :
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Does risk methodology include probability or likelihood and risk impact
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Evidence :
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Is their evidence that methodology is used consistently and effectively
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Evidence :
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Where risks are identified are controls in place
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Evidence :
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Has the organisation identified response actions to improve control measures
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Evidence :
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Are actions planned to address identified risks and opportunities recorded e.g mitigation plan
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Evidence :
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Does the organisation evaluate & review effectiveness of actions at addressing the risks
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Evidence :
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Is the action taken proportionate to the risk or opportunity
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Evidence :
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Does the risk & opportunity register record the date that risks are identified or modified
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Evidence :
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Is risk identification conducted by knowledge, competent persons
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Evidence :
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Does the organisation includes all sources of risk, including those beyond our organization’s control e.g acts of god, political risk etc
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Evidence :
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Does the organisation identify all significant risks that could impact our organization from all risks.
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Evidence :
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Is a risk owner established for development of the response
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Evidence :
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Is a response action owner for each action established
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Evidence :
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Is a response strategy to treat, terminate, tolerate or transfer the risk identified
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Evidence :
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Is there evidence that the risk is reassessed to reflect any newly introduced control measure
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Evidence :
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Are risk and opportunities monitored to determine whether they are current or updated when new emerging issues are identified.
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Evidence :
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Are clear objectives defined for relevant functions, levels and processes within the management system?
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Evidence :
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Where group objectives are in place, are these understood & communicated at site level?
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Evidence :
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Are objectives established throughout the organization?
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Evidence :
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Do objectives support the quality policy?
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Evidence :
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Has the organizations established and maintained one or more management improvement programme for achieving their objectives
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Evidence :
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Are the objectives documented, include targets with clear measures of success? S.M.A.R.T
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Evidence :
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Has a designated responsible person from the relevant function/level of the organization to support in the achievement of the objective been defined.
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Evidence :
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Is an action plan describing how each target will be achieved documented?
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Evidence :
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Has a time-frame or a schedule for achieving each target been defined?
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Evidence :
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Are objectives clearly communicated to staff?
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Evidence :
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Are objectives monitored
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Evidence :
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Is progress against targets reviewed & reported to site senior management
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Evidence :
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Are sufficient resources available to realise objectives
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Evidence :
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Is there a system for determining changes to Processes and procedures
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Evidence :
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Is there a system for determining changes to Quality manual
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Evidence :
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Is there a system for determining changes to Documented information
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Evidence :
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Is there a system for determining changes to Infrastructure
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Evidence :
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Is there a system for determining changes to Tooling & Process equipment
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Evidence :
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Is there a system for determining changes to Employee training
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Evidence :
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Is there a system for determining changes to Supplier evaluation
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Evidence :
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Is there a system for determining changes to Stakeholder management
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Evidence :
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Is there a system for determining changes to Interested party requirements
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Evidence :
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Are quality management system changes that affect processes communicated to personnel
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Evidence :
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Are changes monitoring to ensure that changes are effectively implemented
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Evidence :
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Where changes that impact the management system are made are records available
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Evidence :
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Is organizational knowledge reviewed before changes are made
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Evidence :
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Has the organisation considered the potential consequences of the change (risk and opportunities)
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Evidence :
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Has the organisation consider how the change effects the current process
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Evidence :
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Are resources allocated to affect change
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Evidence :
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Where required by the change are allocation or reallocation of responsibilities and authorities assigned?
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Evidence :
Opportunity For Improvement
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Number of OFI raised :
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Details
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Have the OFI details been added to HubSpot
Non-conformance
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Number of Non-conformances raised :
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Details
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Have the Non-conformance details been added to the HubSpot