Quality Management Audit

I have to do an internal audit of Quality Management in my company.  While I have a basic idea what Quality Management encompasses, I am not sure how to go by auditing this system.  Can someone give me some pointers?  Does anyone have a checklist?  Thanks.  :helpplease:

First: :Welcome: to IFSQN Astrid!

Second: Well I guess I need to ask you a question or two:

Are you auditing the Food Safety part of your factory or the actual quality of the product? 

If you are auditing the quality of your product you may want to look at things like product specifications and if you are meeting them.  If a product is supposed to have a moisture of 13.5%-15% and you are consistently making a product of 16% that's not good for quality.  Also you can look at your customer requirements and make sure you are meeting those for the product and possibly procurement (are you attaining the required amount of pallets/cases/product units that your customer needs?  Are you sending the right amount?  Are you sending too much?)

SQF Level 3 has a Food Safety component and a Food Quality component.  If you were to look at SQF level 3 and take out the stuff that is in Level 2 that could give you an idea about Food Quality Management.

You can audit your sanitation - good sanitation leads to better quality product.

Your pest control efforts help as well - better pest control leads to lower chance of an infestation and bugs getting into your product.

All idea and thoughts.. I'm sure others will chime in.  If you have more questions feel free to ask.

Thank you very much for your input.  I actually work in the chemical/pharmaceutical business, not the food business, but this site has been a huge help since they are very similar.

The audit schedule has me down as auditing 'Quality Management' and no other explanation is given as to what to check.  You have given me some ideas, though.

Thanks again,

Astrid

Ah ok well yeah they are pretty close to each other.  If you have any other specific questions please feel free to ask.

Thank you very much.  :smile:

Also - stick around :)  I often wonder what a pharm co would do in my situation, beucase when I was interviewing I looked at a lot of them, and they always seemed so

CLEAN and ORGANIZED

and I'd just die for control over a facility like that.  Beautiful!  Stainless steel!  Controlled air flows! 

Ah, I'm jealous

Will do.  :thumbup:

I have to do an internal audit of Quality Management in my company.  While I have a basic idea what Quality Management encompasses, I am not sure how to go by auditing this system.  Can someone give me some pointers?  Does anyone have a checklist?  Thanks.  :helpplease:

will you be auditing against a standard such as ISO9001 or  ICH Q10?

Q10 guidance here   ISO9001 checklist here

Mike

Hi Mike

We are not ISO certified, so I will auditing against ICH Q10.  I am also currently reading Chapter 1 of the Eudralex in preparation for my audit.

Thank you very much for the above information.  I have opened the links and glanced at the information.  It appears to be perfect to familiarize myself more with the task at hand.

Astrid

Hi Mike

 

We are not ISO certified, so I will auditing against ICH Q10.  I am also currently reading Chapter 1 of the Eudralex in preparation for my audit.

 

Thank you very much for the above information.  I have opened the links and glanced at the information.  It appears to be perfect to familiarize myself more with the task at hand.

 

Astrid

Hi Astrid

Also have a look at the attached- skip to Chapter 20 for the Q10  (QM stuff!) (it's an aide memoire for inpectors-so may be useful to you!)

Mike

Hi Mike

Thank you very much for the information, including the spreadsheet which will be very useful. 

With everyone's help I feel a lot more confident in being able to perform an excellent Quality Management Audit.

Have a great weekend,

Astrid

Hi Mike

 

Thank you very much for the information, including the spreadsheet which will be very useful. 

 

With everyone's help I feel a lot more confident in being able to perform an excellent Quality Management Audit.

 

Have a great weekend,

Astrid

No problem -I hope it  all goes well for you!

Mike

Dear All Good Day

I have tried to develop a checklist for Internal Quality Auditing with some change in relation to departmental compliance of the clause for my use rather than just wording by wording to standard.

Its a food for thought and needs feedback of IFSQN fellow mmbers.

Looking forward to your valueable feedbacks.

Regards,

W@Q@S

Our internal audit procedure outlines the different areas that need to be audited, such as Production, Quality Management, Laboratory, Materials Management, Equipment, etc.  It states in our procedure that these areas need to be audited every two years.

I don't know if listing areas would apply to you or not.

I like our checklist.  :-)

Astrid