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Are GMP's implemented as a separate program? Or part of the QMS?

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Jean Carmona

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Posted 14 June 2018 - 03:53 PM

Hello we are a packaging company for food packaging but we don't handle food in our facility. I'm the responsible for implementation of the code and i have some doubts that you might help me with.

 

 

1. I took the code original transformed into word and i highlighted everything and i'm using it as a guide to accomplish every step by step. i have developed the QMS with test, inspections sheets for raw materials as final product as well. The point is i'm responding to some questions inside of that Code so they use it as a guide to know how things works in the company. Is this ok?

 

2. Are the Good manufacturing practices implemented as a separate program? is part of the QMS? or can i put this into the SQF code that i talked about.

 

 

Thank you, looking forward to hear your recommendations.

 

 



jcieslowski

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Posted 14 June 2018 - 06:33 PM

I don't understand your first question well enough to give you a meaningful response.

 

To your second question, GMPS are a component of the food safety and quality management system (like pest control, chemical control, supplier approval, etc.).  In your case, look at SQF code 12.3 and 12.4 to see what SQF requires your GMPS to cover.



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Jean Carmona

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Posted 14 June 2018 - 06:56 PM

what do you don't understand of my first question ? i took the code 8 i transformed the pdf into a word and i am answering some questions inside of that document. for example they require a method to handle the complaints i created a form in adobe and took a screeenshot and paste that in the document. So the original code instead of questions will be full of the answer im providing with their requirements. is this ok ? or should i manage the complaints thru a separate program like the quality management system.

 

ok i got you. Gmps are part of the food safety and quality management system (like pest control, chemical control, supplier approval, etc.). 

 

is that the same as the quality management system or is this a separate program?



Charles.C

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Posted 14 June 2018 - 07:34 PM

Hi Jean,

 

Implementation of GMP(s) (mainly involving hygienic status of environment/equipment/personnel) is regarded as a preliminary activity to be carried out prior to implementing HACCP (process focussed).

 

The whole system is typically regarded as a FSMS structure.

(Some texts regard the HACCP component as a FSMS system in itself also, it's just a question of "terminologies")

 

You may have to post an example of yr current methodology  to get an answer to yr 1st query. I'm not a SQF user but, as I understand, individual Programs are required to be developed where requested in the Code.


Kind Regards,

 

Charles.C


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Scampi

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Posted 14 June 2018 - 07:59 PM

GMP

Good 

Manufacturing

Practices

 

They are the heart and soul of food manufacturing (including packaging) in that the best written plans out there fall apart when simple things like handwashing and hairnets are not followed 

 

QUALITY is not the same as SAFETY.  I think you're trying to combine existing QUALITY parameters with newly implemented food safety programs


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Jean Carmona

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Posted 15 June 2018 - 11:29 AM

Let me see if i get this straight 

 

I have to create a Food Safety Management System where main purposes is the Gmp's and HACCP is this correct?



jcieslowski

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Posted 15 June 2018 - 02:52 PM

I have one book I call "Food Safety and Quality Management" and it serves as the basis for all my policies, sops, etc.  The outline of the Food Safety and Quality Management book follows my standard (it used to be SQF but at my current position it is the 7-11 audit standard).  It starts with things like scope and purpose of the plan, management commitment, and moves into all the other components (pest control, record retention, training, sanitation, pest control, allergen control, maintenance, incoming materials, new product development, etc. etc.).  

 

I don't believe that jotting notes on the code itself would be sufficient to satisfy the SQF requirements in terms of providing 'methods and responsibilities' for all of the things that SQF requires you to do that for.  For example, the code says to provide methods and responsibilities for calibration and you noted: "QA manager calibrates monthly" - that's a good start, but it doesn't outline the specific steps that would be better elaborated on by making a "calibration standard operating procedure" QA manager calibrates all thermometers by putting them in an ice water bath and comparing to a certified calibrated NIST thermometer.  That thermometer is certified by an accredited 3rd part laboratory (w/ accreditation paperwork on file), etc. etc.   

 

I think what you're doing is a great start but don't think it's going to satisfy an auditor.  I think it's a good way to look at gaps in your plan and get everything organized but then you should take your notes and expand them into a procedure for each topic.



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dfwdilemma

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Posted 18 June 2018 - 01:45 PM

Jeanc, I think you're on the right track. Since you handle food packaging, you will also need other sections along with GMPs: pest control, allergen control, supplier programs, etc.

 

There is nothing wrong with including screenshots, but be prepared because I do not think it will be enough to satisfy the auditor's needs. 

 

The manual is where you can compile everything and add links to the individual processes. 

 

Let me know if this answer helps! 



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Jean Carmona

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Posted 18 June 2018 - 02:31 PM

Jeanc, I think you're on the right track. Since you handle food packaging, you will also need other sections along with GMPs: pest control, allergen control, supplier programs, etc.

 

There is nothing wrong with including screenshots, but be prepared because I do not think it will be enough to satisfy the auditor's needs. 

 

The manual is where you can compile everything and add links to the individual processes. 

 

Let me know if this answer helps! 

 

 

Yes i understand so much better what to do thank you all for the answer provided.

 

I was answering all in the code iteself but was not just simples notes i was putting the procedures and all in there but know i understand the difference between quality manual and the food safety management system are two different programs.

 

Let's see if i don't get confused knowing what goes to what program. haha

 

Thank you all for the help!!



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Posted 18 June 2018 - 03:08 PM

Probably once you've got your systems up and running you will be able to combine them

 

Are you starting both from scratch at the same time?  That's a huge undertaking, even for an experience person


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Jean Carmona

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Posted 18 June 2018 - 03:15 PM

Probably once you've got your systems up and running you will be able to combine them

 

Are you starting both from scratch at the same time?  That's a huge undertaking, even for an experience person

 

Yes starting both from scratch but i'm up to it. they want a audit for this year so i'm a in a rush right now haha. But i already designed the quality manual with all the inspections for raw materials as production with statistical process control also. we're low risk so we shouldn't have so much problems, i hope.

 

already finish the HACCP also, btw, i'm a little confused because in the HACCP as i told you we are a low risk company, we don't have to calibrate thermometers and that kinda works. my haccp plan is more like monitoring the cleaning and that kinda programs having a glass control etcetera. what happens when you don't have a critical control point? you just avoid that step?

 

Sorry if a went out of main subject of the topic.



Scampi

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Posted 18 June 2018 - 03:43 PM

I'm assuming you've prepared a through hazard analysis of your facility?  If so, then the analysis should list all of the Pre Reqs that cover each hazard. If no CCPs then no CCPs (lucky you).  Not every process will have any, and a good auditor should know that.

 

http://www.inspectio...035?chap=4#s8c4

 

This is my preferred method of hazard analysis, the backbone of my entire program (SQF or otherwise)  I've included an example

 

 

That is the whole point behind a well done HA. Where people get stuck is not completing the H A properly and thinking everything is covered when it isn't

 

A CCP is put in process when the hazard CANNOT BE REDUCED to an acceptable level by any other means

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Jean Carmona

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Posted 18 June 2018 - 03:53 PM

I'm assuming you've prepared a through hazard analysis of your facility?  If so, then the analysis should list all of the Pre Reqs that cover each hazard. If no CCPs then no CCPs (lucky you).  Not every process will have any, and a good auditor should know that.

 

http://www.inspectio...035?chap=4#s8c4

 

This is my preferred method of hazard analysis, the backbone of my entire program (SQF or otherwise)  I've included an example

 

 

That is the whole point behind a well done HA. Where people get stuck is not completing the H A properly and thinking everything is covered when it isn't

 

A CCP is put in process when the hazard CANNOT BE REDUCED to an acceptable level by any other means

 

 

Great thanks for the info, i have placed sops, prp's, coa, letters of guarantee and other measures that i took i'm pretty sure i covered all the hazards.

 

Last question Scampi and thank you so much for helping me out.

 

Im starting to write the FSMS. do you have any template to use as a guide. Because my trouble is in the management responsibility 2.1.2 of the code it says "The reporting structure describing those who have responsibility ensuring food safety of the packaging shall be identified and communicated within the site.

 

I have developed this structure with the plant manager and we have in place the jobs descriptions and everything, i know this is asking me for the roles of each personnel food safety related.

 

BUT, should i use the same scheme-form as the code to write down the FSMS? or there is another structure of this program that i can use. 

 

Thank you so much Scampi!



Scampi

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Posted 18 June 2018 - 04:01 PM

Use whatever works best for your and your site, but DO NOT name names, list positions that way you don't have to change this policy every time you have a personnel change

 

I've posted an org chart in a couple of places and in the program I have used bullets to list out who's responsible for what,employees on the floor simply need to know to whom they report an issue, supervisor or lead hand, shift supervisor, QA.....so a short simple statement in your GMP training should cover this off


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Jean Carmona

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Posted 18 June 2018 - 04:09 PM

Use whatever works best for your and your site, but DO NOT name names, list positions that way you don't have to change this policy every time you have a personnel change

 

I've posted an org chart in a couple of places and in the program I have used bullets to list out who's responsible for what,employees on the floor simply need to know to whom they report an issue, supervisor or lead hand, shift supervisor, QA.....so a short simple statement in your GMP training should cover this off

 

 

Great then, Thank you Scampi, you were very helpful.



Scampi

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Posted 18 June 2018 - 04:11 PM

you're welcome!


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Jean Carmona

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Posted 19 June 2018 - 03:13 PM

you're welcome!

 

Hey Scampi, to meet the code in the statement 2.1.2.3 and 2.1.2.2 where it explains that the senior site management shall adequate provisions and resources to ensure food safety.

 

do i have to create a management statement or a policy for this?. 

 

We have in place pest control and further programs that in fact talks by itself that the company are using resources to ensure the food safety.

 

Thank you!



Scampi

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Posted 19 June 2018 - 03:32 PM

Yes, just a management statement that is SIGNED BY MANAGEMENT---that's the key factor on this one

. A broad statement that simply says

"company X is financially stable and understands and accepts that capitol is required to maintain the food safety system including staff and equipement" or some such thing

 

It's a policy that demonstrates management commitment to the entire program


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Jean Carmona

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Posted 19 June 2018 - 03:47 PM

Excellent Scampi Thank you very much. Will write you here if anything more goes up but i expect not to haha thank you my friend!!



Jean Carmona

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Posted 20 June 2018 - 05:24 PM

Hello Scampi hope you're doing well. Sorry for bothering you but i'm developing now the 2.1.3 part of the code for management review and i have developed some tables that explains what program are we monitoring, document name for inspection, verification guidance, who do the monitoring function for that program frequency of the verification so it's like a schedule for the monitoring functions of gmps, pest control, cleaning programs, quality, training of personnel, haccp. Do i have to include this table that i have developed in the FSMS as part of the management reviewing process or i just name it and keep the tables and inspections forms on server? 

 

Thank you!



jcieslowski

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Posted 20 June 2018 - 05:59 PM

Use whatever works best for your and your site, but DO NOT name names, list positions that way you don't have to change this policy every time you have a personnel change

My auditor would NOT accept this and made me update senior management flow chart (to manager level) with every personnel change.  I argued that it was unnecessary but sometimes you need to go along to get along.



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Posted 21 June 2018 - 02:24 PM

I would ask the auditor where in the code is says that names are required. It doesn't matter "who" it is that been assigned responsibility, but rather that person in position X is

 

This does not make food safer!

 

2.1.2.1 The reporting structure describing those who have responsibility for food safety shall be identified and
communicated within the site. 
 
Drives me nuts when auditors cannot see that it fulfills the requirement. If you're in a facility with a really high turnover rate, this can turn into a nightmare, and if you want to be extra picky EVERYONE has a responsibility to food safety, so are we expected to list out the names of say 175 employees on the line??
 
Sorry for the rant, I'm just incredibly frustrated with auditors these days!!!!!!!!

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Posted 21 June 2018 - 06:47 PM

The process is: Complete your PRPs (PreRequisite Programs) including your GMPs, then perform your HACCP and HAQCP according to the 12 steps and 7 pillars of HACCP. The GMPs should cover behavioral issues of your employees like hand washing, proper handling of personal items, Building security (all doors closed and locked at all times), Visitor procedure and policy, uniform / dress, tobacco use, chemical use and handling, food consumption, glass and ceramic use prohibition. The rest of your PRPs should cover the physical issues like building condition and maintenance, equipment and process design, maintenance, sanitation, material storage etc. Once you've completed those, as a packaging manufacturer, you will likely find no CCPs necessary as you have addressed them through your PRPs. if your PRPs are not completed you might have done a lot of work you'll need to undo or scrap. Hope this helps and hang in there, it's a lot of tedious albeit necessary work. I hope your audit goes well. Also, any chance owners / upper management might consider a gap audit or analysis?





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