Audit Checklist for an External Microbiological Laboratory

Has anyone an audit checklist for an external microbiology laboratory that they'd like to share? I am working on one, I'd like a comparison to make sure I haven't missed anything

Has anyone an audit checklist for an external microbiology laboratory that they'd like to share? I am working on one, I'd like a comparison to make sure I haven't missed anything

Hi, I am quite new to quality but through our approved supplier I request that the external lab must be Nata Certified, have their business registration, qualifications, approal of place for quarantine and any other certificates that they hold. I hope that this helps you.

Hi, I am quite new to quality but through our approved supplier I request that the external lab must be Nata Certified, have their business registration, qualifications, approal of place for quarantine and any other certificates that they hold. I hope that this helps you.

Thanks Carol,

The lab is certified but we want to do an audit for another reason.....

Thanks Carol,

The lab is certified but we want to do an audit for another reason.....

I would look at caibration records for any kit they may have, proficiency testing of the staff, expiry dates on agars and reagents, internal audits, relevant test methods for the product. The usual stuff that they fall down on.

Caz x

agree with caz.. but i add update accreditation number from certain body...

Here's what I have so far:

Qaulity System - Sample traceability
training records
Complaint handling
Corrective action procedures
Use of sub-contractors

Premises and Location - Fabrication
segregation of operations
Housekeeping and hygiene
Personal Hygiene- Changing areas
PPE
Jewellery policy
Hand washing
Medical Screening/return to work

Raw Material Control- Raw material specifications
Approved Supplier List
Storage of chemicals
segregation of chemicals
Stock rotation
Control of chemicals
Media Preparation
Cleanliness of prep area/ equipment
Stock control
Batch control
Heat treatment records
calibration
storage of prepared media
sterility checks

Sample preparation - Sample reception
Housekeeping
Standard Operating Procedures/ Training

Instruments and equipment - Maintenance schedule
Service records
calibration records
Temperature records ( water baths and incubators, fridges)
Type of safety cabinet inuse

Sample analysis - Housekeeping
Standard Operating procedures
review of SOP
referencing of SOPs

Reference cultures - ATCC referenced
appropriate cultures used
storage of cultures
positive and negative controls


Would it be appropriate to ask to see their latest certification report?

Would it be appropriate to ask to see their latest certification report?

Always appropriate to ask, i'd even ask for it before i went to audit!

Caz x

Has anyone an audit checklist for an external microbiology laboratory that they'd like to share? I am working on one, I'd like a comparison to make sure I haven't missed anything

Hi trubertq,

Please see attched

Hi Azaam

Great document - many thanks for sharing it with us.

Makayla

Thanks Azaam, that's a great help!

Hi trubertq,

Please see attched

Slightly , apologies.

Dear azaam nafiz,

May I enquire how you evaluate / proceed from the answers to the Y/N questions in your nice list?.

I ask because many small scale factory micro. labs I have encountered would undoubtedly have a substantial number of Ns. i appreciate it relates to the activities but to take one simple example, I have rarely seen a laminar flow hood, anywhere.
For professional labs, eg certified to iso17025, inevitably a different story.

Rgds / Charles.C

PS - Based on my lab. experiences, I would suggest one more question for yr list -
"Is there a (verified) fire extinguisher(s) present ?"

This is  very nice checklist it has lots of info for auditing the lab.Tks

 

Regards Benito.