Jump to content

  • Quick Navigation
Photo
- - - - -

HELP! GMP 13.4.1.2

GMP 13.4.1.2 SQF

  • You cannot start a new topic
  • Please log in to reply
31 replies to this topic

#1 Loni Banaszak

Loni Banaszak

    Grade - MIFSQN

  • IFSQN Member
  • 69 posts
  • 2 thanks
2
Neutral

  • United States
    United States
  • Gender:Female
  • Location:Kent. Ohio
  • Interests:Animals, Garage Sales, Tea Cups, Antiques and Disney

Posted 27 April 2015 - 01:26 PM

Good Morning!

 

I have a question. After searching on this site about GMP I see a lot of people who use a GMP Checklist? Since the SQF Guidance documents I have do not touch on 13.4.1.2 and I can't seem to find anything buried on the internet I thought you guys could help me. Because you always give the best help!

 

My auditor is asking for a GMP Procedure, I have no clue what's supposed to be in it I though GMP was about Hygiene (Personal/Plant) PPE those types of things. Am I missing something because I had covered all that in our sanitation process.

 

If someone could tell me what exactly what points you are supposed to hit in a GMP Procedure for SQF maybe I can point her in the direction of other processes we have in place.


  • 0

Thanks,

 

Loni


#2 Setanta

Setanta

    Grade - PIFSQN

  • IFSQN Principal
  • 959 posts
  • 220 thanks
115
Excellent

  • United States
    United States
  • Gender:Female
  • Interests:Reading: historical fiction, fantasy, Sci-Fi
    Movies
    Gardening
    Birding

Posted 27 April 2015 - 01:35 PM

I THINK the question your auditor wants to know is how are you verifiying that your procedures are being followed?  That's where the checklist comes in.  If you have a checklist performed at specific times of the day/shift, you can show that yes, your GMPs are being followed.


  • 0

-Setanta                 WeepingAngela.gif

 


#3 Loni Banaszak

Loni Banaszak

    Grade - MIFSQN

  • IFSQN Member
  • 69 posts
  • 2 thanks
2
Neutral

  • United States
    United States
  • Gender:Female
  • Location:Kent. Ohio
  • Interests:Animals, Garage Sales, Tea Cups, Antiques and Disney

Posted 27 April 2015 - 01:38 PM

I THINK the question your auditor wants to know is how are you verifiying that your procedures are being followed?  That's where the checklist comes in.  If you have a checklist performed at specific times of the day/shift, you can show that yes, your GMPs are being followed.

 

Thank you, But what is supposed to be in the checklist, they are already complaing about all the paperwork I make them complete now, Id hate to add something that wasn't necessary of we were covering it somewhere else.


  • 0

Thanks,

 

Loni


#4 Setanta

Setanta

    Grade - PIFSQN

  • IFSQN Principal
  • 959 posts
  • 220 thanks
115
Excellent

  • United States
    United States
  • Gender:Female
  • Interests:Reading: historical fiction, fantasy, Sci-Fi
    Movies
    Gardening
    Birding

Posted 27 April 2015 - 04:09 PM

Well, they should be checking for whatever your GMPs. We have jewelry, hairnets, candy, utensil checks, temp checks, etc. Please see attached

 

 


  • 0

-Setanta                 WeepingAngela.gif

 


#5 Setanta

Setanta

    Grade - PIFSQN

  • IFSQN Principal
  • 959 posts
  • 220 thanks
115
Excellent

  • United States
    United States
  • Gender:Female
  • Interests:Reading: historical fiction, fantasy, Sci-Fi
    Movies
    Gardening
    Birding

Posted 27 April 2015 - 04:10 PM

Here it is...

Attached Files


  • 0

-Setanta                 WeepingAngela.gif

 


#6 Loni Banaszak

Loni Banaszak

    Grade - MIFSQN

  • IFSQN Member
  • 69 posts
  • 2 thanks
2
Neutral

  • United States
    United States
  • Gender:Female
  • Location:Kent. Ohio
  • Interests:Animals, Garage Sales, Tea Cups, Antiques and Disney

Posted 27 April 2015 - 05:21 PM

Here it is...

Thank you, I guess Ill have to add one more checklist for them! lol they wont be happy.......

 

Loni


  • 0

Thanks,

 

Loni


#7 Loni Banaszak

Loni Banaszak

    Grade - MIFSQN

  • IFSQN Member
  • 69 posts
  • 2 thanks
2
Neutral

  • United States
    United States
  • Gender:Female
  • Location:Kent. Ohio
  • Interests:Animals, Garage Sales, Tea Cups, Antiques and Disney

Posted 27 April 2015 - 06:12 PM

Here it is...

Oh one question after reviewing the checklist sample you provided, Are you having your Supervisors complete this checklist? and How are you making sure people are washing there hand, as in how are you confirming they are meeting your required standard.


  • 0

Thanks,

 

Loni


#8 Setanta

Setanta

    Grade - PIFSQN

  • IFSQN Principal
  • 959 posts
  • 220 thanks
115
Excellent

  • United States
    United States
  • Gender:Female
  • Interests:Reading: historical fiction, fantasy, Sci-Fi
    Movies
    Gardening
    Birding

Posted 27 April 2015 - 07:20 PM

Can you incorporate this into another of your checks?

 

For us, this is a snapshot done by QA. They are observe people washing their gloved hands as they enter the production area.


  • 0

-Setanta                 WeepingAngela.gif

 


#9 Loni Banaszak

Loni Banaszak

    Grade - MIFSQN

  • IFSQN Member
  • 69 posts
  • 2 thanks
2
Neutral

  • United States
    United States
  • Gender:Female
  • Location:Kent. Ohio
  • Interests:Animals, Garage Sales, Tea Cups, Antiques and Disney

Posted 27 April 2015 - 07:35 PM

Can you incorporate this into another of your checks?

 

For us, this is a snapshot done by QA. They are observe people washing their gloved hands as they enter the production area.

I don't really think I have any where else to place this, I think it will have to be a separate check.  Which is fine they can deal with it. I am just trying to figure out who should do the check, since we aren't handling food, we can observe that people are washing hands after eating and smoking, but then again our sinks are located inside the bathroom where they can close the door


  • 0

Thanks,

 

Loni


#10 xylough

xylough

    Grade - MIFSQN

  • IFSQN Member
  • 146 posts
  • 103 thanks
21
Excellent

  • United States
    United States
  • Gender:Male
  • Location:SanFrancisco Bay Area (Oakland, Lake Merritt)
  • Interests:"Foodie" stuff, dogs, family, horticulture, natural sciences

Posted 27 April 2015 - 07:36 PM

Loni,

 

Another way to approach/conceive of this verification that program GMP are followed and reduce redundancy is as training validation. Methodically pre-select individuals or practices to observe and or question per day, then immediately document your observations or conclusions of questioning on a well designed brief.  Be sure to have corresponding CAPA for the individuals who fail to comply or for the practices that are weak. A register helps to track who has training validation and who does not. 

 

Regards


  • 0

#11 Kelly S

Kelly S

    Grade - MIFSQN

  • IFSQN Member
  • 89 posts
  • 32 thanks
9
Neutral

  • Australia
    Australia
  • Gender:Female
  • Location:Brisbane
  • Interests:Sci Fi Geek, Book Lover, Chef-in-my-own-kitchen, Eclectic Music Collector

Posted 04 May 2015 - 05:33 AM

This sort of thing has, in my experience, always been a QA check. In my last few roles I would do a floor check a set time (either every hour or every 2 hours) and check everything including people and their PPE, the general cleanliness of the area, CCP's recorded and condition of product/packaging. It's sounds laborious but it was only ever a 10 min check, less if one or 2 of the lines weren't running. I think the risk of having a non-QA employee do this check is the potential for them to mark as ok to save themselves any hassles which an auditor may query if there are no QA GMP checks.


  • 0

“Will this be on the test?" "Yeah, about the test. The test will measure whether you are an informed, engaged, and productive citizen of the world, and it will take place in schools and bars and hospitals and dorm rooms and in places of worship. You will be tested on first dates, in job interviews, while watching football, and while scrolling through your Twitter feed. The test will judge your ability to think about things other than celebrity marriages, whether you’ll be easily persuaded by empty political rhetoric, and whether you’ll be able to place your life and your community in a broader context. The test will last your entire life, and it will be comprised of the millions of decisions, that when taken together, make your life yours. And everything — EVERYTHING — will be on it.”

                  -  John Green


#12 Maretha

Maretha

    Grade - Active

  • IFSQN Associate
  • 12 posts
  • 3 thanks
0
Neutral

  • South Africa
    South Africa

Posted 18 May 2015 - 09:43 AM

Good day!

 

We have checklists for every department, e.g. our Maintenance department has a GMP checklist containing the following questions: 1. No signs of pests or vermin (required by Iso 22000), 2. No standing water (also required), 3. No broken glass/hard plastic (required), 4. There is running water, drying paper, and soap available at handwash station (required), and then the rest of the questions they choose themselves to keep their area clean (food safety) and neat, e.g. the workshop floor is washed, there are no tools lying around, the maintenance request list is up to date, etc. What I'm basically getting at, is that you can create a checklist for every department and it helps a great deal to keep everyone at the same standard, as well as complying to ISO 22000. We do weekly GMP checks for every department, I gather all the scores (we do percentages because not everyone has the same amount of questions, 10 questions minimum, but not too much to be too time consuming!) and then we have a Measurable Objective to try and get everyone above 80%. You could also plot this on a chart and present it at the Management Review. Good indication of what is going on in each department.

 

Hope this helps!


  • 0

Thanked by 2 Members:

#13 Loni Banaszak

Loni Banaszak

    Grade - MIFSQN

  • IFSQN Member
  • 69 posts
  • 2 thanks
2
Neutral

  • United States
    United States
  • Gender:Female
  • Location:Kent. Ohio
  • Interests:Animals, Garage Sales, Tea Cups, Antiques and Disney

Posted 18 May 2015 - 01:30 PM

Good day!

 

We have checklists for every department, e.g. our Maintenance department has a GMP checklist containing the following questions: 1. No signs of pests or vermin (required by Iso 22000), 2. No standing water (also required), 3. No broken glass/hard plastic (required), 4. There is running water, drying paper, and soap available at handwash station (required), and then the rest of the questions they choose themselves to keep their area clean (food safety) and neat, e.g. the workshop floor is washed, there are no tools lying around, the maintenance request list is up to date, etc. What I'm basically getting at, is that you can create a checklist for every department and it helps a great deal to keep everyone at the same standard, as well as complying to ISO 22000. We do weekly GMP checks for every department, I gather all the scores (we do percentages because not everyone has the same amount of questions, 10 questions minimum, but not too much to be too time consuming!) and then we have a Measurable Objective to try and get everyone above 80%. You could also plot this on a chart and present it at the Management Review. Good indication of what is going on in each department.

 

Hope this helps!

Thank you This will help ALOT!!!!


  • 0

Thanks,

 

Loni


#14 Maretha

Maretha

    Grade - Active

  • IFSQN Associate
  • 12 posts
  • 3 thanks
0
Neutral

  • South Africa
    South Africa

Posted 18 May 2015 - 01:50 PM

My pleasure! We are also in the stages of getting ISO 22000 certified, Stage 1 audit in August!


  • 0

#15 Charles.C

Charles.C

    Grade - FIFSQN

  • IFSQN Moderator
  • 12,447 posts
  • 3244 thanks
346
Excellent

  • Earth
    Earth
  • Gender:Male
  • Interests:SF
    TV
    Movies

Posted 18 May 2015 - 01:57 PM

SQF Packaging = ISO22000 Food ?

 

Then again, i guess it's mostly generic. :smile:


  • 0

Kind Regards,

 

Charles.C


Thanked by 1 Member:

#16 Maretha

Maretha

    Grade - Active

  • IFSQN Associate
  • 12 posts
  • 3 thanks
0
Neutral

  • South Africa
    South Africa

Posted 18 May 2015 - 02:12 PM

Charles, I am sure Loni is smart enough to adjust her questions according to her relevant standard. But as far as I know, GMP stands for General Manufacturing Principles in ALL standards, no?


  • 0

Thanked by 1 Member:

#17 Loni Banaszak

Loni Banaszak

    Grade - MIFSQN

  • IFSQN Member
  • 69 posts
  • 2 thanks
2
Neutral

  • United States
    United States
  • Gender:Female
  • Location:Kent. Ohio
  • Interests:Animals, Garage Sales, Tea Cups, Antiques and Disney

Posted 18 May 2015 - 02:24 PM

From what I have researched GMP seems to hit in ALL the standards lol. Just trying to get everyone on board is my issue :(


  • 0

Thanks,

 

Loni


#18 Charles.C

Charles.C

    Grade - FIFSQN

  • IFSQN Moderator
  • 12,447 posts
  • 3244 thanks
346
Excellent

  • Earth
    Earth
  • Gender:Male
  • Interests:SF
    TV
    Movies

Posted 18 May 2015 - 04:20 PM

Hi Loni,

 

Not sure if you have abandoned the part of yr OP related to 13.4.1.2 but as far as i can see it requires "Procedures". The Checklist would appear to be an additional  issue.

 

As per the format shown, the Guidance for 13.4.1 includes all of subs 1-3 but i agree with you that the list of "evidences" shown is contradictory.

 

Sadly I could not find any forum comments relating to 13.4.1.2 from other SQF Packaging users. Perhaps they simply ignored it. Dot2 does not appear to exist in any other modules so perhaps the author of (13) decided to add it as a novelty.

 

Additionally one must always remember that the Guidance is only a non-binding "suggestion", albeit a tantalising one. :smile:

 

The auditor has the final word.


  • 0

Kind Regards,

 

Charles.C


#19 Loni Banaszak

Loni Banaszak

    Grade - MIFSQN

  • IFSQN Member
  • 69 posts
  • 2 thanks
2
Neutral

  • United States
    United States
  • Gender:Female
  • Location:Kent. Ohio
  • Interests:Animals, Garage Sales, Tea Cups, Antiques and Disney

Posted 18 May 2015 - 05:58 PM

Hi Loni,

 

Not sure if you have abandoned the part of yr OP related to 13.4.1.2 but as far as i can see it requires "Procedures". The Checklist would appear to be an additional  issue.

 

As per the format shown, the Guidance for 13.4.1 includes all of subs 1-3 but i agree with you that the list of "evidences" shown is contradictory.

 

Sadly I could not find any forum comments relating to 13.4.1.2 from other SQF Packaging users. Perhaps they simply ignored it. Dot2 does not appear to exist in any other modules so perhaps the author of (13) decided to add it as a novelty.

 

Additionally one must always remember that the Guidance is only a non-binding "suggestion", albeit a tantalising one. :smile:

 

The auditor has the final word.

 

 

Well, After a bit of back and forth this was what we received a NC on for GMP

 

 

Our actual finding listed below.

 

2.1.3.2 Food Safety Management

 

Item: A food Safety Manual shall be documented, maintained , made available to relevant staff and include or reference the written procedures, pre-reqs, food safety plans and other documentations necessary to support the development and the implementation, maintenance and control of the SQF System.

 

Evidence: The company has documented a Quality Manual (Quality-002) which outlines the methods used to meet the requirements of the standard. Some programs needed to maintain the SQF Management System were not documented such as management review.

 

A list of pre-reqs was also included but it was noticed that not all programs are referenced such as Personal practices/GMP, control of chemicals, Monitoring of water and air quality.

 

So now I am sitting here wondering exactly what is supposed to go into a GMP pre-req. The standard to me isn't clear at all.


  • 0

Thanks,

 

Loni


#20 Setanta

Setanta

    Grade - PIFSQN

  • IFSQN Principal
  • 959 posts
  • 220 thanks
115
Excellent

  • United States
    United States
  • Gender:Female
  • Interests:Reading: historical fiction, fantasy, Sci-Fi
    Movies
    Gardening
    Birding

Posted 18 May 2015 - 06:14 PM

Damn! I had a post and lost it.  We are not under section 13, but it looks close in verbage to Section 2. This is what we have for that:

 

The purpose of this policy is to document the Food Safety Plan in place and that these documents are developed, validated, verified, and maintained including sign off by the SQF Practitioner for FACILITY. The supplier shall ensure that the food safety fundamentals described in the relevant subsequent modules of this Code (i.e. modules 3-15) are applied or exempted according to risk analysis outlining the justification for exclusion or evidence of the effectiveness of alternative control measures to ensure food safety is not compromised.

  1. The premises, building, and equipment design shall be located, constructed, and designed to facilitate a safe food product.
  2. The Facilities are maintained in a structurally sound and operated in a sanitary manner.
    1. A site plan showing the location of the premises and the surrounding land use.
    2. Evidence from the local authority indicating that the premises are approved for that purpose.
  3. The premises, buildings, and equipment must be located, constructed, and designed to facilitate proper processing, handling, storage, and delivery of safe quality food.
  4. Food Safety Fundamentals include Prerequisite Programs:
    1. Pre-requisite Programs include programs applicable to SQF Level II Certification and validated and verified according to the SQF Code.
      1. Personnel Practices
      2. Personnel Processing Practices
      3. Training of Personnel
      4. Calibration of Equipment
      5. Management of Pests and Vermin
      6. Monitoring Water Microbiology
      7. Control of Physical Contaminants
      8. Supplier Approval
      9. Transport and Delivery
      10. Waste Management and Disposal
    2. Methods and practices to provide basic environmental operating conditions essential for processing of safe foods
    3. GMP and/or Sanitation Practices that include Federal and state programs that the plant falls under including but not limited to USDA, FDA, and State of Minnesota.
    4. The plant will have a Food Safety Plan depicting what is being done, hazards that are present, and what the control measures are; including listing what the critical control points are and how they are being controlled
    5. The Food Safety Plan will be developed using the HACCP method with demonstration of how it is being used.

  • 0

-Setanta                 WeepingAngela.gif

 


#21 Setanta

Setanta

    Grade - PIFSQN

  • IFSQN Principal
  • 959 posts
  • 220 thanks
115
Excellent

  • United States
    United States
  • Gender:Female
  • Interests:Reading: historical fiction, fantasy, Sci-Fi
    Movies
    Gardening
    Birding

Posted 18 May 2015 - 06:18 PM

It looks like part of what you are missing is Management Review. As I update our SOPs each year, I send them to Senior Management for them to physcially sign off.  I list two managers and myself as signatories.


  • 0

-Setanta                 WeepingAngela.gif

 


#22 Loni Banaszak

Loni Banaszak

    Grade - MIFSQN

  • IFSQN Member
  • 69 posts
  • 2 thanks
2
Neutral

  • United States
    United States
  • Gender:Female
  • Location:Kent. Ohio
  • Interests:Animals, Garage Sales, Tea Cups, Antiques and Disney

Posted 18 May 2015 - 06:25 PM

It looks like part of what you are missing is Management Review. As I update our SOPs each year, I send them to Senior Management for them to physcially sign off.  I list two managers and myself as signatories.

 
 That's the thing, we have a management review process, And our auditor reviewed it.
 
See Management review attached. Maybe I just missed something that I cant see.
 

Attached Files


  • 0

Thanks,

 

Loni


#23 Setanta

Setanta

    Grade - PIFSQN

  • IFSQN Principal
  • 959 posts
  • 220 thanks
115
Excellent

  • United States
    United States
  • Gender:Female
  • Interests:Reading: historical fiction, fantasy, Sci-Fi
    Movies
    Gardening
    Birding

Posted 18 May 2015 - 06:35 PM

Do they physcially sign off on the docs?


  • 0

-Setanta                 WeepingAngela.gif

 


#24 Loni Banaszak

Loni Banaszak

    Grade - MIFSQN

  • IFSQN Member
  • 69 posts
  • 2 thanks
2
Neutral

  • United States
    United States
  • Gender:Female
  • Location:Kent. Ohio
  • Interests:Animals, Garage Sales, Tea Cups, Antiques and Disney

Posted 18 May 2015 - 06:36 PM

No we control everything electronically, even signatures.


  • 0

Thanks,

 

Loni


#25 Setanta

Setanta

    Grade - PIFSQN

  • IFSQN Principal
  • 959 posts
  • 220 thanks
115
Excellent

  • United States
    United States
  • Gender:Female
  • Interests:Reading: historical fiction, fantasy, Sci-Fi
    Movies
    Gardening
    Birding

Posted 18 May 2015 - 06:43 PM

How do you demostrate that management has given their approval or has done a review?


  • 0

-Setanta                 WeepingAngela.gif

 






0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users