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 organization identified which resources it needs to make available in order to ensure the effective operation of your QMS including raw materials, infrastructure, finance, personnel and IT
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Evidence :
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Has the organization considered the need for external resources in addition to the need for internal resources.
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Evidence :
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Does the management review minutes include evidence of resource allocation.
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Evidence :
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How are resource requirements reviewed – Identify staffing needs versus headcount HR
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Evidence :
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Are competencies required for each position defined
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Evidence :
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Are job descriptions appropriate
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Evidence :
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Has the organisation outlined the recruitment and selection process
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Evidence :
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The organisation identified initial training requirements
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Evidence :
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Are training files developed for each employee, including management identifying and tracking employee training requirements
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Evidence :
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Does the organisation verify that the personnel have received the planned training
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Evidence :
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Has the organization determined, provided, and maintained the infrastructure for the operation of processes to achieve product and service conformity – building, tools, equipment, utilities, IT etc
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Evidence :
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Does the organisation managed & control work environments required to achieve product conformity
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Evidence :
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Has the organisation determined the continued improvement of the facility through informal or formal review meetings
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Evidence :
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Is there good lighting, ventilation, safe passageways, stairs and corridors
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Evidence :
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Are working equipment, tools and process maintained
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Evidence :
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Are safe methods of work in place – observe
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Evidence :
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Has the organisation provided safe means for handling, storage, use and transportation of equipment, materials and chemicals
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Evidence :
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Has Top management provided the leadership & direction for establishing strategies to use organizational knowledge and policies and objectives
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Evidence :
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Has the organization identified the scope of organizational knowledge relevant to its business and related risks and opportunities associated with each type of organizational knowledge
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Evidence :
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Has the organization defined the process needed to manage organizational knowledge - identify, obtain, accumulate, store, communicate, use, maintain, protect and evaluate the performance of organizational knowledge management against objectives
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Evidence :
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Has the organization defined roles, authority and responsibilities for organizational knowledge process activities
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Evidence :
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Has the organization determined competency requirements and provided appropriate training and awareness for all employees using organizational knowledge
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Evidence :
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Has the organization established processes for communication, participation and consultation
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Evidence :
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Has the organization determined the nature and extent of documentation required to manage organizational knowledge
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Evidence :
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Has the organization identified any applicable regulatory and other requirements
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Evidence :
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Has the organization defined & implemented an organizational knowledge change management process?
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Evidence :
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Has the organization performed organizational knowledge activities – assign responsibilities, identify, obtain, accumulate, store, maintain, protect, communicate, use and evaluate the performance of organizational knowledge?
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Evidence :
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Has the organization tracked organizational knowledge performance measures?
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Evidence :
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Does the organization investigate loss, irretrievability or theft of organizational knowledge
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Evidence :
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Has the organization evaluated compliance to applicable regulatory requirements
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Evidence :
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Has the organization maintained appropriate records of organizational knowledge management activities
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Evidence :
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Has the organization verified achievement of organizational knowledge goals and objectives
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Evidence :
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Is there a documented list of equipment & its location
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Evidence :
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Are devices identified in such a way that the user can determine that the device has current calibration; i.e marked in accordance with calibration requirements
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Evidence :
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Are devices calibrated at a pre-determined intervals or prior to use
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Evidence :
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Are devices calibrated by external providers certified to ISO 17025
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Evidence :
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Are devices calibrated to a defined method, traceable to a national or international standard [where there is no standard available for the device the basis for calibration or verification must be recorded]
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Evidence :
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Are records of calibration maintained – sample check
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Evidence :
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Are records of verification maintained – sample check
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Evidence :
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Are devices safeguarded from adjustment, which may invalidate results
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Evidence :
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Are devices protected from misuse & handled and stored in a manner to protect the equipment from damage through design or the training of staff
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Evidence :
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Are procedures in place to record actions to be taken when the prescribed devices are found not to be operating within specified limit
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Evidence :
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Equipment found to be out of calibration are adjusted/re-adjusted by qualified personnel
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Evidence :
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Computer software which is used for monitoring/measuring is validated prior to initial use;
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Evidence :
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Computer software used for monitoring and measuring is re-validated where necessary
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Evidence :
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Has the organization summarised major training initiatives and activities planned for the given budget year?
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Evidence :
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Have employee training needs been identified? Including existing workers, new hires, temporary workers and outside contractors?
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Evidence :
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Are training plans developed, implemented? Have competency-based training needs been identified - Review training plans for selection
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Evidence :
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Are training plans reviewed regularly to ensure that they are up to date and meet current demands.
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Evidence :
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Is training scheduled and prioritized according to the needs of the work area
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Evidence :
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Where established has training been undertaken before commencement of work
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Evidence :
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Are training requirements for employees assessed against wider organizational policies and objectives.
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Evidence :
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Are abilities and competencies of workers monitored?
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Evidence :
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Are training needs determined during the appraisals process?
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Evidence :
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Are suitable training matrices produced for each workplace?
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Evidence :
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Are legislative requirements, including license requirements or management system requirements identified e.g. IFS training needs
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Evidence :
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Is Employee training and re-training recorded, monitored and kept up to date by their Line Manager and Supervisor
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Evidence :
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Is a training register containing information on specified levels of education, training, and experience established for each employee whose work is involved with any significant impact and safety hazard
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Evidence :
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Does training material emphasize responsibility for minimizing significant impacts and risks associated with their work
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Evidence :
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Does training material identify potential consequences of departures from specified operating procedures & address the benefits of improved personal performance
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Evidence :
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How is competency evaluated or demonstrated e.g., through tests, observations, results
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Evidence :
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Is the person performing the activity able to demonstrate his or her competencies?
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Evidence :
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If the person is found not to be competent, how does the organisation take action to raise competence to the required level
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Evidence :
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Is on-the-job training provided by a more experienced employee or by an external trainer, skilled in the requirements of that particular activity as indicated by their training record
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Evidence :
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Are training plans updated on a regular basis by the Line Manager to reflect the training status
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Evidence :
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Are employees encouraged to request further training to aid their personal development
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Evidence :
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Has the organisation considered its future needs?
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Evidence :
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Do employees understand the importance of conformance with the quality policy and the management system procedures and requirements
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Evidence :
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Is awareness training undertaken [broad-based training provided to increase employee awareness]
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Evidence :
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Does awareness training material include key elements of the management system
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Evidence :
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Does awareness training material include the importance of compliance with operational and regulatory requirements
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Evidence :
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Does awareness training material include the overall improvement aims of the management system
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Evidence :
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Does awareness training material include the importance to interested parties
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Evidence :
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Are records of attendance at awareness training available
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Evidence :
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Do employees understand their role for minimizing significant impacts and risks associated with their work
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Evidence :
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Are procedures established to make employees aware of the benefits of personal performance
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Evidence :
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Are procedures established to make employees aware of their roles and responsibilities in achieving conformance with policies and procedures
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Evidence :
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Are procedures established to make employees aware of the benefits of the potential consequences of departure from specified operating procedures
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Evidence :
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Do all new recruits (workers, contractors and temporary staff) receive induction training or briefings
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Evidence :
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Does training programmes including Tricel core values and policies, company overview & history, the people and structure, contract of employment, induction pack, health, safety and environmental briefing
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Evidence :
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Are induction records completed, signed by each participant & retained – sample check
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Evidence :
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Where tool-box-talks are used for general awareness training is there an attendance list completed & signed by each participant
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Evidence :
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Is the person providing the tool box talk documented on the records.
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Evidence :
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Has the organization identified the necessary internal and external communications that are required for the operation of the management system
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Evidence :
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Has the organisation identified when & how communications will occur?
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Evidence :
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Your organisation needs to ensure that procedures to control internal and external communications and interfaces are in place include enforcement authorities, lawyers/solicitors, insurance companies
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Evidence :
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Do all documents have identification?
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Evidence :
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Do all documents have an appropriate format? Date, title, revision number etc
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Evidence :
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Have all documentation been reviewed and approved?
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Evidence :
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Are all documents in the correct place?
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Evidence :
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Is all documented information protected from tampering, unauthorized changes, and damage?
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Evidence :
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Is documented information available in the correct language?
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Evidence :
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Are employees able to access all documentation easily?
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Evidence :
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Has the organisation specified where all documentation is located?
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Evidence :
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Is the organization able to ensure that the correct versions of documented information are available?
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Evidence :
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How long does the organisation retain documentation? Does the retention period meet customer and regulatory requirements
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Evidence :
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Does the documented information guide the production of products provided by the organization?
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Evidence :
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Is documented information of external origin used for the development of the QMS controlled – standards available, of the correct version
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Evidence :
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Are records legible, completed in real time & in good condition?
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Evidence :
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Are any alterations to records authorised & recorded?
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Evidence :
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Are records appropriately verified [include signature of operator or supervisor verifying records]
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Evidence :
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Are records maintained & retrievable?
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Evidence :
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Are records completed in a manner that accurately transmits the intended information
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Evidence :
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Where records are in electronic form are these suitably backed up?
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Evidence :
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Are electronic records controlled? e.g., Security policy, password rules, storage and back-up policy including protection from loss, corruption, physical damage
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Evidence :
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Are authorisation levels for amending electronic documents defined to prevent unauthorized changes, unintended alteration?
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Evidence :
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Does the organisation test electronic retrieval systems & are records of tests retained?
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Evidence :
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PN111 - 6) Does the organisation hold and update a register of "Critical Components"?
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Evidence :
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PN111-6) Does the organisation maintain a master list that details all QMS documents?
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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 HubSpot