11 replies to this topic

[MMQA]

I have a constant situation where management is not ensuring the requires checks and documentation are completed each day, including some of the preventive controls (mainly sanitation and ovens, we do baked goods) QA is constantly chasing down managers to get trainings scheduled, with no cooperation. We speak to the managers to remind them that these checks are not optional, we send emails with lists of missing paperwork. It feels like a loosing battle because we cannot keep up or make lasting changes. This is in addition to many other problems with management commitment, building issues and hygiene that I feel like I am falling into a black hole daily. How have other pcqis managed these issues?. I do plan to do a complete reassessment of the plan as I have been at this facility for half a year and would like to update many things.

[Brothbro]

Does your facility have a "QA Manager" who is of at least equal authority to production managers? This kind of role is essential to turning this situation around, someone in the QA department needs to have the authority to stop production if things are too far out of compliance. Beyond that the CEO or company owner does need to have the commitment to back QA up. You say the checks aren't optional, but from production's perspective they certainly seem that way. They become mandatory when you show that production is stopped when these the requirements of your system aren't met.

Edited by Brothbro, 07 May 2024 - 09:59 PM.

[MMQA]

Does your facility have a "QA Manager" who is of at least equal authority to production managers? This kind of role is essential to turning this situation around, someone in the QA department needs to have the authority to stop production if things are too far out of compliance. Beyond that the CEO or company owner does need to have the commitment to back QA up. You say the checks aren't optional, but from production's perspective they certainly seem that way. They become mandatory when you show that production is stopped when these the requirements of your system aren't met.

Yes i hold the highest position in QA and have definitely considered implementing a check that if the forms are not available production cant start. I see it as my next step especially with the sanitation forms

[Tony-C]

Hi MMQA,

 

It is always disappointing to hear that someone is struggling to get support they need from the management team in their facility. I would be writing to them to confirm what paperwork is expected from them in order to ensure compliance with food safety regulations. Deficiencies in paperwork should then be reported and copied to senior management.

 

Good luck, sometimes a stick is needed, I have been known to turn up to management meetings even if not invited and present deficiencies/deficient paperwork.

 

Kind regards,

 

Tony

 

[Dorothy87]

 

Hi, 

 

I would start with documents review 

 

- Often they are not staff friendly, contains way too many signatures and unnecessary checks. This must be verified by you against the procedures and third party audit standards. 

- be clear about documents, (for example managers signatures at the bottom, QA signs on the left at the bottom) - someone could say that this will make them "blind" which is not true. 

- Show new version of documents to managers, let them know that they are user friendly and easy. Ask for suggestions, encourage them to make a change. 

- Training should be organised by you with simply rules (why we doing this (legality/BRC etc), how to do this, who should sign, responsibility and where to leave documents), no longer than 20 min - (always inform managers how long the training will take, this will help to schedule production and they will be more keen to join your training) 

- Write an email to your director / head of about all changes made 

- forward a weekly issues log to director / head of with all NC`s raised against missing documents, the director should prompt the managing director to chase production managers. 

 

good luck !

 

 

 

 

 

 

. 

Edited by Dorothy87, 08 May 2024 - 10:24 AM.

[Scampi]

You need HR on your side

 

Repeated violations of the program should be disciplined as per your companies policy (but i have the feeling you don't have one of those either)

 

On the quicker side, you can change forms whenever you want without having to reassess your plan, maybe it is partially because the form is overly complicated/difficult to complete (and maybe not)

 

Since you've mentioned you've been there less than a year, perhaps schedule an OPEN meeting where you ask questions regarding how your predecessor ran the department.  I have been in many facilities where QA was the "police" and other department heads felt resentment due to not having a voice in what is feasible in practice.  Sometimes it's just a matter of building trust.

 

Having said all of that, you also mentioned lack of management commitment, if you genuinely feel that this is a top down issue---you're best bet is to brush up your resume, and remember to ask some specific questions about management style in your next interview(s)  

 

We all a highly technical, skilled profession, we are not super heros.  Know your worth 

[MMQA]

You need HR on your side

Since you've mentioned you've been there less than a year, perhaps schedule an OPEN meeting where you ask questions regarding how your predecessor ran the department.

No one has lasted more than a few months, it has been this way for a few years. I am in the process of changing the form and who is assigned to it and added a verification check for sanitation (to be done by qa) which the manager was visibly upset about, so that says alot….

Edited by MMQA, 08 May 2024 - 03:58 PM.

[jfrey123]

The nuclear option is to start putting finished goods on hold.  You find a batch record with missing PC checks, you have the authority to place it on hold and investigate.  Production and sales will lose their god damned minds, so be ready for arguments, but your SOP's should include the release criteria and I'd bet the release of goods depends on all the PC checks being completed and reviewed.

 

You can warn them ahead of time: citing your internal SOP, whatever relevant GFSI codes you are licensed under, and even relevant CFR (21 CFR 110.93 for example, dictating that "Storage and transportation of finished food shall be under conditions that will protect food against physical, chemical, and microbial contamination as well as against deterioration of the food and the container.")  If your team isn't performing the checks prescribed by your SOP's and HACCP plan, then you haven't protected the food against the physical, chemical and microbiological contaminations your own program has identified and it should  not be shipped. Explain to them that QA cannot release these finished materials for sale and distribution if the checks have not been completed.

 

Everyone else above has great idea to try and make it a team effort.  Keep my nuclear option as a last resort, but just bear in mind if a recall happens and FDA/USDA finds your company was willfully negligent in documentation of PC steps, they're going to look at you first as the PCQI.  If you can't work with these teams to make change happen, it might be time to start looking elsewhere for supportive employment.

[MMQA]

Everyone else above has great idea to try and make it a team effort. Keep my nuclear option as a last resort, but just bear in mind if a recall happens and FDA/USDA finds your company was willfully negligent in documentation of PC steps, they're going to look at you first as the PCQI. If you can't work with these teams to make change happen, it might be time to start looking elsewhere for supportive employment.

This is my concern, i feel that i am in a situation where im already loosing. By the time i was able to start digging there were already big issued and as pcqi I feel it will all fall on me despite my efforts. I am looking elsewhere but it takes time… in the meantime i am trying to find a way to get things back on track

[MDaleDDF]

I agree with JFREY.   You don't wanna hang with my food safety stuffs?   Cool.   I will not release batches for shipment.   Wanna fire me?  Here's the face I'd give um:

 

 

I was lookin fer a job when I found this one....

Edited by MDaleDDF, 08 May 2024 - 05:24 PM.

[MMQA]

Moving forward i may have to take this approach, what would be the best course of action for everything prior? This is where I am getting stuck today.

[jfrey123]

The only thing I can think of is to check batch records, and throw a write up into each one missing records.  Perform a review/investigation of what you can measure related to the missing docs, and see if you can qualify whether the food was produced safely even with the missing checks.  Check notes from other forms, check other records like any daily checks or audits that refer to the area or machines used, and verify no issues were reported.  Then copy these investigations into a CAPA form, as the missing checks are a deviation from your FS program, and root cause why the checks weren't done.  Use this to talk to senior management about getting the deficiencies corrected, letting them know it cannot continue or materials will have to be put on hold.