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Document control

Has a document control procedure been established and maintained?


All the relevant documents readily locatable?
Are they periodically reviewed and revised as necessary and approved for
adequacy by authored personnel
Are they suitably identified as obsolete if retained for legal or knowledge
Are the documents legible,
Readily identifiable
Maintained in an orderly manner?
Does the organization have any documented process?
Does the organization use the version control?
Does the organization have revision control process?
Does organization follow workflows?

Audit management system


Does organization have a formal group that is responsible for audits?
Does organization carry out the Internal audits in planned intervals?
Is there any procedures for defining responsibility and authority for handling
and investigating non conformances?
Do the audit procedures cover audit scope frequency ,methodologies and the
reporting results?

Management Review:
Is there any management review process?
Do you carry out management reviews?
Does your management carry out management reviews at planned intervals?
Do you review the performance reviews?
Do you maintain a record of your management reviews?
Do you record the results of management reviews?
Do you examine the results of prior management reviews?
Do you examine management review follow-up actions?
Do you examine previous MR results?
Is process 100% repeatable or traceable?

DAH:
Any procedure to identify DAH Of facility’s activities that it can control?
Has the concept of control been consistently and effectively applied
Are the significant impacts identified?
Are the criteria for evaluating significant impact consistently applied and
classified?
Is the information been kept up to date?
Objects & Targets
Is the organization maintained objectives and targets at each relevant
function level within the organization?
Have the following areas been considered in the establishment of objectives
and targets in
Significant environmental DAH
Financial operations and business requirements
Legal and other requirements
Technological options
Are the objectives and targets been reviewed
Are the objectives consistent with policy?
Are the objectives & Targets
quantifiable?
Can set a relevant timeframe
Relevant to each function level
Is the organization developed any action plans to achieve the objectives and
targets
Does the plan include responsibility for achieving objectives & Targets at each
relevant function level
Do you maintain programs to achieve your Q/E/H objectives and targets?
Legal and Other Requirements
Is there any procedure to identify the legal and other requirements
Has the organization established and maintained a document procedure for
periodically
Evaluating compliance with relevant legislations and regulations?

Operation control
Are the operations and activities that are associated with the identified
significant DAH been identified?
Are the operations identified in line with the organizations policy, objectives &
Targets?
Is the organization planned these activities
Do they have relevant operational controls ?
Do they measure operational controls on a regular basis

CAPA
Is the procedure include the recording of information to track performance
Equipment calibration
Is monitoring equipment calibrated and maintained
Have records of this process been retained to the organization procedures
Do the procedures provide for the action to reduce the impact and notify
relevant parties if monitoring equipment is found to be out of calibration?

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