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Management Still Not Getting It.

Preventing Mixed Produce

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#1 PEACEQUEEN

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Posted 21 December 2017 - 05:38 PM

I am at the point of wanting to pull my hair out.

 

When my team and I read through the HACCP Plan sections for printed food packaging, line clearance at every stage in the process was defined as a risk area for mixed product.

 

I explained that a pre-requisite program for line clearance that is documented, reviewed and approved by supervisors with all final records reviewed by SQF Practitioner and filed electronically, would prevent this from being a CCP.

 

They refuse to accept that this needs to be done in any manner that falls into the other SQF SOP's and records I have created.  That SQF Practitioner does not need to keep these records in the manner I have set up the entire SQF/HACCP documentation thus far.

 

They claim it is not feasible with the amount of jobs created here.  That keeping this paperwork in the Job Bag is all that needs to happen and during the audit, you just bring the auditor to the job bags.  However, these job bags will have no SQF Practitioner involvement?  My head is ready to pop.

 

Can an expert please summarize what SQF/HACCP requires to prove line clearance will not result in Mixed Cartons. They don't seem to believe me when I verbalize it.


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#2 Timwoodbag

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Posted 21 December 2017 - 07:07 PM

2.6 Product Identification, Trace, Withdrawal and Recall

2.6.1 Product Identification (Mandatory)

2.6.1.1 The methods and responsibility for identifying raw materials, ingredients, packaging materials, work-in progress, process inputs and finished products during all stages of production and storage shall be documented and implemented. The product identification system shall be implemented to ensure: i. Raw materials, ingredients, packaging materials, work-in progress, process inputs and finished products are clearly identified during all stages of receipt, production, storage and dispatch; and ii. Finished product is labeled to the customer specification and/or regulatory requirements.

2.6.1.2 Product identification records shall be maintained.

2.6.1.3 Product start up and changeover procedures during packing shall be documented and implemented to ensure that the correct product is in the correct package and with the correct label, and that the changeover is inspected and approved by an authorized person.


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#3 Timwoodbag

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Posted 21 December 2017 - 07:10 PM

2.6 Product Identification, Trace, Withdrawal and Recall

2.6.1 Product Identification (Mandatory)

2.6.1.1 The methods and responsibility for identifying raw materials, ingredients, packaging materials, work-in progress, process inputs and finished products during all stages of production and storage shall be documented and implemented. The product identification system shall be implemented to ensure: i. Raw materials, ingredients, packaging materials, work-in progress, process inputs and finished products are clearly identified during all stages of receipt, production, storage and dispatch; and ii. Finished product is labeled to the customer specification and/or regulatory requirements.

2.6.1.2 Product identification records shall be maintained.

2.6.1.3 Product start up and changeover procedures during packing shall be documented and implemented to ensure that the correct product is in the correct package and with the correct label, and that the changeover is inspected and approved by an authorized person.

Accidentally posted that without formatting, I think that 2.6.1.3 is what you are talking about?  If the area has been identified as a risk area, I would say you absolutely need to have some sign-offs from supervisors to "prove line clearance will not result in Mixed Cartons."


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#4 PEACEQUEEN

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Posted 22 December 2017 - 03:17 PM

The more disturbing part is they don't want me to have to review and approve and record.

I am the only SQF Practitioner, Document Control Coordinator and Training Coordinator.

I have therefore implemented electronic recording of what little we have in place for SQF.

Every program I try to develop is met with "it's not feasible for your to record every line

clearance record"  Why does it have to be electronic?  Why can't we just file them with

the job bag like we do now?  Why, Why, Why?????  The only response I get to everything.


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#5 FurFarmandFork

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Posted 22 December 2017 - 03:58 PM

Come up with a better answer than "the code says so". Management is correct to ask "why" if you're pushing things to make the audit easier rather than take steps to improve the safety and quality of the product.


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#6 PEACEQUEEN

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Posted 22 December 2017 - 04:14 PM

The "code says so" is not my answer and "Making it easier" is not and has never been my stance.  The code dictates what is required for all Mandatory areas. Recording is Mandatory. 

 

Another Mandatory section is "Sr. Management shall provide the resources required to ensure the development, implementation and maintenance of the SQF System."

They have 1) Not provided resources and 2) Have not even read the Code provided to them 10 months ago.  Also have no HACCP Team either. I am dealing with an establishment that has never enforced anything at any time in any way and the thought of having to monitor processes is not feasible.  Making it easier!  LOL!!!!!!!  Like that's an option.


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#7 Timwoodbag

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Posted 22 December 2017 - 04:26 PM

I don't think your changeover document has to be too complicated.  Do you have a Manager watching employees while they do changeovers?  Even just somewhat involved?  They can just have a pre-printed stack of papers, grab one, check that the line is cleared of old packaging and new packaging is correct for new product, and pass that along to you.  You can then sign off and scan it in for your electronic copy.  You don't really have to be involved with every product changeover, just have procedures in place to ensure someone responsible is aware of what is being packed.  


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#8 FurFarmandFork

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Posted 27 December 2017 - 04:00 PM

The "code says so" is not my answer and "Making it easier" is not and has never been my stance.  The code dictates what is required for all Mandatory areas. Recording is Mandatory. 

 

Another Mandatory section is "Sr. Management shall provide the resources required to ensure the development, implementation and maintenance of the SQF System."

They have 1) Not provided resources and 2) Have not even read the Code provided to them 10 months ago.  Also have no HACCP Team either. I am dealing with an establishment that has never enforced anything at any time in any way and the thought of having to monitor processes is not feasible.  Making it easier!  LOL!!!!!!!  Like that's an option.

Again, most of the answers you just gave are variations of "the code says so" e.g. ""The code dictates..." "recording is mandatory..". Not saying you don't have a tough culture to fight through, but recognize when you're focusing on the code rather than meeting the requirement itself.

 

You need to find ways in which implementing parts of the code help you improve your quality systems and even production efficiency. I have parts of the code I personally think are overkill, and I risk assess them away or take the dang minor, as long as you address the actual risk and meet the requirement of the code there are a million ways to do it. So lets come up with some creative solutions for your specific gaps.

 

When my team and I read through the HACCP Plan sections for printed food packaging, line clearance at every stage in the process was defined as a risk area for mixed product.

 

 

2.6.1.3 Product start up and changeover procedures during packing shall be documented and implemented to ensure that the correct product is in the correct package and with the correct label, and that the changeover is inspected and approved by an authorized person.

 

An "authorized person" does not have to be you. Do you have any sort of record at all of how many of each product was made that day and when the start/stop times were? I imagine there has to be a record so that you can keep inventory. Add your signature at the end of the day and make sure you are part of the review process for the "job bag" documents you identified. That way they're reviewed on an annual basis with your involvement, and you verify the "inspection" performed by your operator. Demonstrate that this hasn't been an issue  by using your "incident" or complaint tracking log. If there actually have been problems with this in the past, use that data to demonstrate to management how you can eliminate customer complaints and/or rework downtime by implementing a more robust inspection system. But if it hasn't been a problem, don't create a check or paperwork for the sake of the code. Find another way to demonstrate a record.

 

Every program I try to develop is met with "it's not feasible for your to record every line

clearance record"  Why does it have to be electronic?  Why can't we just file them with

 

the job bag like we do now?

 

 

I'd ask the same questions! I use a mixture of electronic and paper records. The only advantage electronic records have over paper is that they can be stored, duplicated, accessed, sorted, and analyzed easier. But if no one is using the records that way, then scanning/data entry is just an extra step with no advantage for you. How many lines are there? Can you do a single page review of products produced the previous day and have some sort of verification activity that helps make sure that there are no mixed cartons independently? My pest control records are 100% paper and I bring them to the auditor, same with tracebility and on-line paperwork. Then we stay on the computer to review all of our quality metrics and SOPs. Describing what the contents of the Job bag are would help us point out how they could be used effectively during an audit. Paperwork reduction should always be a goal to make implementing your system effective, because if you have tons of excess or redundant paperwork, people will mess up the stuff that's really important.

 

 

 Also have no HACCP Team either.

 

 

I'm confused, your first post stated: 

When my team and I read through the HACCP Plan sections for printed food packaging..

 

 

 

Did you mean you don't have a cross-functional HACCP team? Or that it's since been disbanded? Ours meets only when the plan needs to be reviewed.

 

 

"Sr. Management shall provide the resources required to ensure the development, implementation and maintenance of the SQF System."

They have 1) Not provided resources and 2) Have not even read the Code provided to them 10 months ago. 

 

 

 

Your senior management team does not have to read the entire SQF code..that's your job as practitioner.

 

2.1.2.4 Senior site management shall designate an SQF practitioner for each site with responsibility and authority to:

i. Oversee the development, implementation, review and maintenance of the SQF System, including food safety fundamentals outlined in 2.4.2, and the food safety plan outlined in 2.4.3.

ii. Take appropriate action to ensure the integrity of the SQF System; and

iii. Communicate to relevant personnel all information essential to ensure the effective implementation and maintenance of the SQF System.

2.1.2.5 The SQF practitioner shall:

i. Be employed by the site as a company employee on a full-time basis;

ii. Hold a position of responsibility in relation to the management of the site's SQF System;

iii. Have completed a HACCP training course;

iv. Be competent to implement and maintain HACCP based food safety plans; and

v. Have an understanding of the SQF Food Safety Code for Manufacturing and the requirements to implement and maintain an SQF System relevant to the site's scope of certification

 

 

 

 

They're not going to read the code, and it is not essential that they do. What is required is that they hire someone with the capability to read and understand how to implement, and have the authority to implement it. Your company isn't giving you the authority to implement it in the way that you think is best, but that doesn't mean there can't be a conversation about how to meet the requirements in the way that makes the most sense for your company. Not every company is going to embrace SQF as a "culture" and many will just implement what they need to get the certification. This pisses us QA people off but it's still a step in the right direction.

 

As far as evidence of management commitment, they have demonstrated commitment by 1: designating a SQF practitioner meeting the requirements above (which you obviously do), and 2, by having a company that supports the requirements of the code and has had whatever level of investment necessary to meet the requirements in their facility. There isn't a dollar value assigned to the management commitment clause, it's assessed by looking at they systems you've implemented, and the state of your facility. If they won't fix things or implement anything, and you have findings and broken stuff everywhere, then that's evidence of lack of management commitment. 

 

As you look for different solutions, audit yourself against the SQF guidance rather than the code. For example, the guidance for the changeover clause:

What does it mean?

To allow for effective trace back (refer to 2.6.2), recall (refer to 2.6.3) and stock control and rotation (refer to 2.4.9), materials and products at all stages of production must be labelled and identified. How the supplier goes about this is entirely their own choice, as long as product can be identified and tracked at every stage of production.

What do I have to do?

This element is mandatory. The supplier must be able to clearly identify product upon receipt, throughout the process and when it is a finished product. Product that is in-process may be identified in a variety of ways. The site could use bin tags, pallet tags, colors, product tags, etc. The site must be able to demonstrate how the product identification system works for incoming materials, work-in-progress and for finished product. The finished product label needs to contain information that accurately describes the product in accordance to customer specification and/or regulatory requirements in the country of origin and intended country of destination. The supplier is required to prepare a procedure outlining who is responsible for maintaining the product identification system and include in the procedure the methods used to identify product. When shipping finished product, the supplier must ensure the product is clearly identified and that all product identification details are accurately described on dispatch documents or otherwise included with a shipment once it leaves the business.

 

Auditing guidance:

The product identification procedure shall be reviewed initially at the desk audit and compliance to this requirement by observation, and interviews with operational staff, and review of records at each site audit.

The site should expect that the auditor will select product at various stages during the process and ask for the origin of product, raw material supplier, etc. to test the identification system.

Evidence may include:

There is a documented product identification system in place;

 The product identification system is effectively implemented;

 Product is clearly identified during all stages of the process;

 Finished product is labeled to customer requirements;

 Finished product is labeled to regulatory requirements in the country of origin and country of destination;

 All operational staff understands and uses the product identification system.

 

 

Did you approve an SOP/work instructions for changeover that your "authorized personnel" have been trained on and can you demonstrate that this has been sufficient to create proper changeovers via incidence? Requirement has now been met. Applicable records are training records, the actual SOP/work instruction, and your incident log demonstrating that few/no issues have occurred under this system.


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#9 PEACEQUEEN

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Posted 27 December 2017 - 04:02 PM

I agree with your approach, which is what I have drafted up, the push back from management is that having to submit every one of those checklists to SQF Practitioner is not feasible and should not have to be electronically recorded, that just having them on file and completed as they always have should be enough for auditing purposes.

 

Coming from years of working in a compliance background, I know what they are suggesting is not enough.  They will pencil whip most of the documentation to get orders shipped and the actual documents will be incomplete if SQF does not demand proper process and recording.


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#10 PEACEQUEEN

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Posted 27 December 2017 - 08:02 PM

There is so much to address regarding the SQF status of my situation.  Yes, we had a HACCP Team which has since disbanded and has not be reformed.  We have had 3 CEO's in 10 months, on our 2nd VP of Ops, and every  other position has been restructured.  Hard copy paperwork has not worked in the past and will certainly not work in the future.  After watching the quality team fail desperately at trying to oblige the Pre-assessment Auditor's request to trace all raw materials related to a job bag forward and backward.....it was most evident that a formal document control electronic process, which is the only manner I have been trained to maintain a successful document control outcome, would need to be enforced.   I have spent 10 months watching people, lose, misplace, search for or fail to even complete hard copy paperwork.  In my world that is just not acceptable and not a system I can embrace if I am the resource required to obtain and maintain this certification. After years in document control, I am well aware of the various methods of recording compliance, but the success rate of the electronic method is invaluable. Yes, I could continue to watch well paid staff scour the plant for documentation that may not even exist, but would much rather search a QMS:Drive and in less than 3 minutes be able to product it or determine that it was never submitted.


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#11 cindyhaz

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Posted 03 January 2018 - 10:40 PM

I understand your frustration. Here's a thought. You might consider reframing your needs. Are you approaching this as a HACCP/SQF requirement or as part of your FSMA Food Safety Plan? Are you the PCQI? Would these be considered preventive controls?  As I understand it, even if not a PC, any documents referenced in the Food Safety Plan must be accessible to FDA. 

 

It's easier for management to try to get through the SQF audit and take the possible hit of a few points. FDA always arrives unannounced. Violations can be very costly, especially if the inspector finds a reason to return and starts charging the hourly rate. 

 

Though I love getting high scores on audits, compliance with FDA is mandatory. In today's world, management is being held accountable and in some cases, legally prosecuted. Being able to retrieve completed documents quickly is more important than ever. Rather than making sure your management team understands the code, perhaps it's more important they understand FSMA and the weight FDA gives traceability.

 

You must be prepared. My company just went through an FDA audit on the one day I was in training out of state. The inspectors spent almost nine hours going through all of my records, some that were technically out of bounds. My management team was sweating bullets because I couldn't help them. Thankfully, there were no violations. 


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#12 PEACEQUEEN

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Posted 04 January 2018 - 03:19 PM

Cindyhaz,

 

Thank you for your response.  New Year, new approach.  We have just compiled a new SQF/HACCP Mandatory Team that will meet weekly.

I started Document Control Training for all Managers right now because the entire concept and value of a formal document control system is

completely foreign to them.  Once they grasp that just using any form thrown at them is not going to work, then I can guide them through the

rest.  It will still be tough and a lot of work.  But feel much more confident now that I have a new plan and attitude!


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#13 Plastic Ducky

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Posted 17 January 2018 - 09:37 PM

Peacequeen,

 

At my facility, it is an identified CCP that mixed graphics could occur at various points throughout the production floor. This is a possibility because production employees will splice the next job into the prior to avoid restringing the film throughout the machine (press/laminator/slitter/pouch machine). To address this we have added an item to the pre-existing quality control inspection sheet that is filled out at the beginning of each Job. This "item" simply requests that the QC employee (who is qualified and trained to do so) either notes that the Job was actually strung through the machine with no pre-existing material present (which is rare because production uses the splice method constantly to save set up time) OR the QC employee identifies and signs the actual splice itself which is then stored in the "Job Jacket". This splice that they sign displays the marriage of the two jobs, the prior job on one side of the tape and the latter on the other. Having this proof is our method of showing that there are no mixed graphics and that each product is identified as is (which also ties into the allergen control issues in packaging via allergen statements on the packaging). We are SQF level three and have maintained this "defense" to address this concern for several years. I hope that something in what I have shared may help you and I wish you the best. :-)


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#14 PEACEQUEEN

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Posted 18 January 2018 - 01:08 PM

Thank you Plastic Ducky,

 

This is very helpful.  We are printed paperboard, but I'm sure we can apply this method to slitting, sheeting, printing etc....


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