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Audit Checklist for an External Microbiological Laboratory


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trubertq

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Posted 21 April 2013 - 01:05 PM

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


I'm entitled to my opinion, even a stopped clock is right twice a day

Carol88

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Posted 21 April 2013 - 11:28 PM

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.


trubertq

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Posted 22 April 2013 - 07:11 AM

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.....

I'm entitled to my opinion, even a stopped clock is right twice a day

cazyncymru

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Posted 22 April 2013 - 08:55 AM

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

Edited by cazyncymru, 22 April 2013 - 08:56 AM.


AS NUR

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Posted 22 April 2013 - 09:53 AM

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



trubertq

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Posted 22 April 2013 - 10:39 AM

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?


Edited by trubertq, 22 April 2013 - 10:46 AM.

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cazyncymru

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Posted 22 April 2013 - 12:34 PM



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


azaam nafiz

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Posted 23 April 2013 - 06:14 AM

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

:thumbdown:

Attached Files



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Wine Gum

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Posted 23 April 2013 - 07:08 AM

Hi Azaam

Great document - many thanks for sharing it with us.

Makayla



azaam nafiz

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Posted 23 April 2013 - 07:12 AM

Hi Azaam

Great document - many thanks for sharing it with us.

Makayla



:thumbup:


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trubertq

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Posted 23 April 2013 - 09:03 AM

Thanks Azaam, that's a great help!


I'm entitled to my opinion, even a stopped clock is right twice a day

Charles.C

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Posted 23 April 2013 - 03:45 PM

Hi trubertq,

Please see attched

:thumbdown:


Slightly :off_topic: , 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 ?" :smile:

Kind Regards,

 

Charles.C


Tina Huynh

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Posted 03 June 2013 - 03:42 AM

The document is useful for everybody! Thanks



m.erzetti

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Posted 17 June 2013 - 02:43 PM

On ACCREDIA site (but only in italian languages) there is a ISO 10725 checklist for Laboratory http://www.accredia....L_DS_Rev_01.pdf



benito

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Posted 25 October 2014 - 10:37 AM

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

 

Regards Benito.






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