K
kiwilass
We have been redeveloping our QMS using a process mapping software system which links in all the information needed to carry out the process (i.e. forms, SOPs, policies etc) into each relevant process and ties in the requirements of about 15 different accreditation standards.
On the basis that our Quality department ensures that they have are aware of where the accreditation gaps are and work on addressing these with the relevant team and track where exactly each accreditation requirement is demonstrated within our system to show that we fulfil the specific requirement listed.
I would like to formalise an generic internal audit sheet to be used by our internal auditors against any chosen processes, which would cover the following points:
- Process name and version number being assessed.
- Auditor and Auditees and date of audit
- Is the process documented being followed as described?
- Are staff involved aware and understand the process and have access to the procedure and how are they informed of changes to the process?
- Maintenance and service records - is there any maintenance or service (including calibration) required to be carried out? Records available to show service has been carried out and are these being conducted on time?
Ideally I don't want to have to go down the path of formalising individual audit sheets that cover each variation and detail within the process. However is the above too simple in terms of an internal audit sheet? Is there anything glaring that I have missed out completely?
Thank you in advance for any feedback given.
On the basis that our Quality department ensures that they have are aware of where the accreditation gaps are and work on addressing these with the relevant team and track where exactly each accreditation requirement is demonstrated within our system to show that we fulfil the specific requirement listed.
I would like to formalise an generic internal audit sheet to be used by our internal auditors against any chosen processes, which would cover the following points:
- Process name and version number being assessed.
- Auditor and Auditees and date of audit
- Is the process documented being followed as described?
- Are staff involved aware and understand the process and have access to the procedure and how are they informed of changes to the process?
- Has the procedure being reviewed in the timescale required?
- Training - Are staff involved in the process trained and do they have training records for staff to confirm training has taken place?- Maintenance and service records - is there any maintenance or service (including calibration) required to be carried out? Records available to show service has been carried out and are these being conducted on time?
- Testing ? Is there any testing required as a direct result of the procedure are these within expected limits and samples taken as required?
- Records ? verify that the records being described by the process are being filled out to completion and signatures are identifiable and records are kept for time frame specified?
- Document Control - are the documents described within the process being utilised and/or displayed and are the correct version number? There are no other documents being utilised that aren't controlled (confirmed) as described within the process?
- Inspection of equipment ? is equipment utilised in a clean state and suitable for use? Is cleaning being carried out as scheduled?
- Process improvement - are suggestions for improvement to the process being reviewed and responded to accordingly?
- Records ? verify that the records being described by the process are being filled out to completion and signatures are identifiable and records are kept for time frame specified?
- Document Control - are the documents described within the process being utilised and/or displayed and are the correct version number? There are no other documents being utilised that aren't controlled (confirmed) as described within the process?
- Inspection of equipment ? is equipment utilised in a clean state and suitable for use? Is cleaning being carried out as scheduled?
- Process improvement - are suggestions for improvement to the process being reviewed and responded to accordingly?
Ideally I don't want to have to go down the path of formalising individual audit sheets that cover each variation and detail within the process. However is the above too simple in terms of an internal audit sheet? Is there anything glaring that I have missed out completely?
Thank you in advance for any feedback given.