7 replies to this topic

[zac2944]

Section 13.2.11.4 of SQF requires that "Pre-operational hygiene and sanitation inspections shall be conducted by qualified personnel to ensure manufacturing and storage areas, staff amenities and sanitary facilities and other essential areas are clean."

 

What exactly is considered "pre-operational" for a 24/7 continuous process operation? Any insight on how to conform here? 

 

I'm making flexible packaging on presses and huge extruders for food industry and have my first SQF audit in April 2014. We do monthly self inspections of all areas of our plant that look at GMPs, hygiene and sanitation by trained inspectors, and machine operators do inspections of production equipment at start of shift and job change overs to make sure all product contact surfaces are clean. 

 

Would these inspections suffice or am I expected to shut my lines down to inspect out bathrooms between every job? 

[zac2944]

Any takers? 

 

Bumping this one to the top.  There's got to be others who've considered this requirement.

[ncwingnut]

We have an audit sheet for each area of our plant.  We choose 2 people per area on a 3-month rotating basis to do the pre-op checks.  One on first shift, one on 2nd shift (we work 2 shifts).

 

At the beginning of the shift, these people are responsible for ensuring there are no issues in their area (ie - scale verifications are completed, there are no GMP violations, area was left clean by previous shift, etc.)

 

We also have a blurb on our batch tickets about ensuring the equipment they are about to use is clean and sanitized.

[w.weber]

Hello,

I do understand pre-operational as restarting after cleaning or maintenance activity. 

- check if all parts are assemled in a good manner

- check cleaniness (visually, swab ...)

- if needed sanitize

- check all moving parts on free movement

- area cleaned up

- old / broken parts removed to waste

- hand over to production...

 

Yours

Werner

[zac2944]

Thanks for your input guys.  My process is continuous and a produciton line might run for 15-30 days before is goes down for any sort of major maintenance or clean up.  We do these sort of inspections throughout a production run and indepentent of production.  There are some inspections that happen for for starting up after shut down, but it certainly doesn't include incpection of bathrooms like the standard suggests.  I do a monthly bathroom inspection regardless of operatoins. 

 

I'm concerned since my inspections aren't "pre-operations" I will receive an audit finding for this. 

[SQFconsultant]

There is obvious leeway here due to 24/7 operation.  Conducting a pre-operational doesn't mean that you have to shutdown in this situation. With that in mind I would expect a once a day or once per shift modified pre-op that includes sanitary facilities. Once a month bathroom inspections are not going to cut it.

[Ekivlen]

With that in mind I would expect a once a day or once per shift modified pre-op that includes sanitary facilities. Once a month bathroom inspections are not going to cut it.

 

Agreed. I couldn't imagine an auditor neglecting the verification that the sanitation program is working due to the fact that production might be slowed.

[fgjuadi]

 a produciton line might run for 15-30 days before is goes down for any sort of major maintenance or clean up. 

 

Holy cow, that's a really long time to run!  At least you only have to clean it a dozen times a year