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GMP Inspection - How to get action ?


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Sabear

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Posted 14 August 2018 - 11:19 PM

Finding resistance in doing inspections. Wondering if this is the norm.

Managers review my findings, and I find myself fighting with them on every topic. "This is getting done (future project)" or "You need to be more lenient on this"

 

Is this the case? Should their be leniency (on my end) when performing inspections over the facility/GMPs?

 

Thank you in advance!



Ryan H.

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Posted 14 August 2018 - 11:56 PM

This is mostly the norm I would say. I would say that it’s important to issue CAPA Corrective Action Preventive Action forms after the inspection is completed so that your team is then preventing reoccurrences. Also even if you find a non conformity/ issue during your inspection and they have a future “fix” for it, write it in your CAPA log anyway. Write down a reasonable date and check on it when it’s completion is due.

What are some typical items you normally write up? How many on average each month?


All the best, 

 

Ryan Heavner 


Ryan H.

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Posted 15 August 2018 - 12:05 AM

I would also like to add that being lenient is not meant for self inspections. Your attempting to be pro active and addressing problems before they become bigger issues. It also helps you in staying on top of your game and being audit ready.

I would like to suggest beginning monthly meetings to review your findings with key management personnel, explain to them what you saw and why it’s a problem, and at that time determine as a group a corrective action, preventive action and date for completion.

You could take pictures of the items your seeing (not employees faces) and it would spur good discussions with the group.


All the best, 

 

Ryan Heavner 


012117

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Posted 15 August 2018 - 12:54 AM

Sarah H.

 

Managers of your same department or other department? Sometimes, these managers from whom you raised findings are "resistive" at times perhaps on how you communicate it to them.  If they felt like you are helping them to address problems by sometimes providing recommendation and use bettwer words, somehow it change their openness with gaps. You may also want to lump some "simpler" observations especially if those type of observations are observed greatly in all areas. Also, while I understand observations are observations and need to be addressed, it must also have "sense-check" from where the plant currently stands. If you give them "laundry-list" without so much contribution to overall must win battles for your plant then they might feel it as additional work.

 

Also replacing some words on how you deliver them (e.g. findings replace with observation or findings without recommendations) makes wonders for your team on the long term.



Sabear

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Posted 15 August 2018 - 02:24 AM

Thank you both for responding. They are done weekly. I am the only person in quality/food safety, so the managers are from different departments.

The most resistance I find are in regard to items being left astray all over the production areas, and product spills. I started recently. But reviewing previous audits. These are long term issues we have had. I use to "go easy" on the inspections. But nothing was getting done. Even though they knew it was an issue.

So I figured if I wrote them down, that change would happen.

I have spoken to them about it before, and other issues verbally. Like leaving the facility doors open that lead to production. And I was just shrugged off.

We have a very poor food safety/quality culture in key personnel unfortunately. And even audit findings tend to not be enough for change to happen, as they just disregard them a month or so after.



Charles.C

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Posted 15 August 2018 - 02:37 AM

Hi Sabear,

 

As per Post 3, it sounds like you need some Management Review meetings. Share the Buck.

 

How much leverage you have/can generate (if any) may depend on future Objectives like FS audits.

 

(Last comment in Post 5 is rather odd to me. do you mean failed audits are ignorable ?? Which FS Standard ?)


Kind Regards,

 

Charles.C


AudreyB

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Posted 15 August 2018 - 01:22 PM

Sabear, 

 

Is your facility certified to any particular standard? Most GFSI standards insist that communication between person responsible for food safety and upper management on a monthly basis at a minimum. If these issues continue to occur, you need to ensure this is communicated to upper management, and that everything you do / say is recorded. 

 

A lack of food safety culture is very prevalent in most facilities unfortunately, and it is extremely difficult and time consuming to change this ... but it is possible. I have faced many of the same issues in my company over the past couple of years, but it is possible to improve these situations. My suggestions to you would be the following:

 

 1) You mentioned you were new to the facility, and new employees (especially in quality) always have a hard time. Employees with more experience (including managers) often do not like new people coming in and analyzing what they do. This is a normal reaction which can be reversed. Did your manager / supervisor fully introduce you (including your previous experience, background) and explain your role to other employees (namely supervisors and managers)? If not, this needs to be done as soon as possible, as it helps to justify your position and why you are doing what you are doing. 

 

2) Make sure you understand the company's background / history. Was the previous person in your position someone who did not get along with the employees in question? Sometimes, the reaction of employees is not against you but against your predecessor. Make sure you understand the company dynamics as well as individual dynamics. Having the skills of reading people and situations is vital for success in this field. 

 

3) Is everyone fully trained and aware of your food safety management system / quality system, and are they aware of their individuals roles and responsibilities? These types of reactions are often due to a lack of understanding behind the why things need to be done a particular way. This also ties in with the company quality and food safety policy, does everyone know the policy? If they do not understand their roles, the policy nor the reasoning behind why they must do something, they will continue to have the same reaction. 

 

4) During your next couple of inspections, complete it with some of the more resistant employees / managers. Give them your inspection checklist and have them fill it out along with you, and allow them to raise their own points. This is a great way for them to feel included in your inspections, and this will also give them a sense of responsibility for what is happening. 

 

5) If you notice something non compliant in your inspection, ask them what their solution is to the situation. If they say "it will be fixed in a project .. blah blah blah", ask them how exactly and why. Get them to think about things. 

 

6) Write everything down and I cannot stress this enough. Beyond your inspection forms and CAPAs, write down who is saying what and when. We often forget little things said in conversation over time, therefore it is vital to write everything down. This will help protect you in the future. 

 

Do not give up! Keep pushing and things will improve overtime. 



SQFconsultant

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Posted 15 August 2018 - 03:09 PM

The absolute best companies in food, logistics and packaging share something really big in common - they all have robust Internal Auditor programs. 

 

We have sold quite a few copies of our  IA training program over the years and we have found that getting as many people involved in the process as possible is a sure winner.

 

My suggestion to each of our clients is that not only should the core employees be taught how to do internal audits but ALL management levels are taught how to do this as well.

 

You will find substantially greater acceptance of your audits if you have anybody trained in doing them and have each one participate as a group exericise in carrying out a couple of them.

 

It will teach them how to view and accept findings - the friction will go away.

 

And if it doesn't they are just a bunch of bad managers and owners.


Edited by SQFconsultant, 15 August 2018 - 03:12 PM.

Kind regards,
Glenn Oster
 
GOC BUSINESS GROUP | SQF System Development, Implementation & Certification Consultants
Internal Auditor Training - eConsultant - Pre & Post SQF-GAP Audits - Consultant Training
Visit us @ http://www.GlennOster.com  or call us @ 772.646.4115 US-EST 8am-4pm Anyday except Thursday
 
 

ts33

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Posted 15 August 2018 - 04:48 PM

Hello Sabear,

 

I think in depth communication about the findings of non-compliance of GMPs with managers and supervisors might help. As if something goes wrong by not fixing something that may compromise food safety, and explaining that what would be the consequences. The company's reputation damage and everyone's employment at the risk. They may understand that doing the right things are important. It's a dilemma when you get stuck with a team members who do not show cares. I wish you the best! 

 

 

Regards,

ts33



Sabear

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Posted 15 August 2018 - 06:53 PM

We are SQF certified and have had our PC audit.
We have had a handful of different auditors say the same thing.

When we have audits everyone tends tongrt on board with targeting what needs to get done. But it quickly fades and they start devaluing the audit findings.

I would love to get others involved, and have tried this approach. I am told its my job.
I appreciate all the helpful hints and will incorporate many of them!



Scampi

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Posted 15 August 2018 - 07:12 PM

When all else fails, put products/equipment etc on hold........that will get there attention. Make friends with management type folks who you believe can help you.(put on hold in shipping system so stuff cannot be picked etc)

 

Get a maintenance person on your side who can lock out the equipment, then no one can use it until the lock out is released!!!

 

OR (playing devils advocate here) keep performing your own audits, and quote the responses you receive....management commitment is part of SQF------once the auditors see responses from management---well you know.  I have had to take this course of action in my past employment (it worked for me and they smartened up, but you have to be really brave to try this approach)


Edited by Scampi, 15 August 2018 - 07:12 PM.

Please stop referring to me as Sir/sirs


John_E

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Posted 15 August 2018 - 07:52 PM

If management is not committed to basic food safety, I would advise finding a new company to work for. If going up the ladder doesn't work, they will never change and just blame you for any failures. That is what happened to me. Management would not take my suggestions seriously, I was fired for them not implementing the required actions, then the company went out of business when Kraft stopped buying from them.

 

-John



Charles.C

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Posted 15 August 2018 - 11:06 PM

We are SQF certified and have had our PC audit.
We have had a handful of different auditors say the same thing.

When we have audits everyone tends tongrt on board with targeting what needs to get done. But it quickly fades and they start devaluing the audit findings.

I would love to get others involved, and have tried this approach. I am told its my job.
I appreciate all the helpful hints and will incorporate many of them!

 

Hi Sabear,

 

Well, someone must presumably be doing something right.

 

Maybe you need to clarify yr "fighting" ?


Kind Regards,

 

Charles.C





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