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Are You Preparing for a Food or Pharmaceutical Product Safety Audit?


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gcse-fhp

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Posted 25 April 2012 - 12:56 AM

1. Be prepared for the audit by documenting, practicing and having the proof (i.e. records) for everything you do

2. Avoid the “Buried Log Syndrome” – records must be readily available

3. Do not argue about anything that you cannot factually substantiate

4. Precisely respond to the auditor’s questions by providing the evidence and facts that substantiate the effectiveness of your system and programs

5. Do not deliberately or otherwise try to overwhelm the auditor with excessive volunteered information about how well things are being managed where the auditor has not asked for that information

6. Do not hijack the audit time through the excessive discussion of speculative solutions for identified deficiencies

7. Do not insist on the history of past performance as evidence of compliance where issues are actually found during the audit

8. Avoid the excessive discussion of future compliance plans that are not documented or verifiable

9. Do not pile up unorganized documents for the auditors to search through when they ask for documented procedures and records

10. Avoid mid-audit development of missing system management documents

11. Do not attempt to rail-road and/or stir the auditor away from areas with non-conformance issues

12. Do not discuss company politics, personal issues or other clients


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Cranberry

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Posted 25 April 2012 - 09:35 AM

11. Do not attempt to rail-road and/or stir the auditor away from areas with non-conformance issues



Surely that is half the fun!


shea quay

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Posted 25 April 2012 - 09:26 PM

Great advice for competent food safety managers, but not much use for the rest of us. I tend to follow these alternative commandments....

1. Don't panic.

2. Refrain from physical violence towards auditors - they are tougher than they look and have a tendency to pull hair.

3. Reassure auditors that the person they just spoke was actually an escapee from a mental institution rather than a staff member. Far easier to correct a site security non-conformance rather than actually bothering to train your staff.

4. Save time and money by starving your auditor - this will cut at least 2 hours off of your audit.

5. Start all responses to the auditor with the phrase "in my defense....."

6. Shout out a booming "Sh*t!" after each non-conformance is read out during the closing meeting. This will convince your boss that you are competent.

7. Don't panic.

I'm currently writing a book - should be in the shops for Christmas.



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gcse-fhp

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Posted 26 April 2012 - 01:08 AM

Great advice for competent food safety managers, but not much use for the rest of us. I tend to follow these alternative commandments....

1. Don't panic.

2. Refrain from physical violence towards auditors - they are tougher than they look and have a tendency to pull hair.

3. Reassure auditors that the person they just spoke was actually an escapee from a mental institution rather than a staff member. Far easier to correct a site security non-conformance rather than actually bothering to train your staff.

4. Save time and money by starving your auditor - this will cut at least 2 hours off of your audit.

5. Start all responses to the auditor with the phrase "in my defense....."

6. Shout out a booming "Sh*t!" after each non-conformance is read out during the closing meeting. This will convince your boss that you are competent.

7. Don't panic.

I'm currently writing a book - should be in the shops for Christmas.


Hi shea quay,

I am curious as to why you have this perspective.

Regards,
gcse-fhp

Some are timid and rob the world of the contributions they can otherwise make.
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Jayqc

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Posted 26 April 2012 - 07:28 AM

Great advice for competent food safety managers, but not much use for the rest of us. I tend to follow these alternative commandments....

1. Don't panic.

2. Refrain from physical violence towards auditors - they are tougher than they look and have a tendency to pull hair.

3. Reassure auditors that the person they just spoke was actually an escapee from a mental institution rather than a staff member. Far easier to correct a site security non-conformance rather than actually bothering to train your staff.

4. Save time and money by starving your auditor - this will cut at least 2 hours off of your audit.

5. Start all responses to the auditor with the phrase "in my defense....."

6. Shout out a booming "Sh*t!" after each non-conformance is read out during the closing meeting. This will convince your boss that you are competent.

7. Don't panic.

I'm currently writing a book - should be in the shops for Christmas.


I'd buy the book :thumbup: Thank you shea quay for giving me the biggest laugh I've had all week, I needed it!


gcse-fhp

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Posted 26 April 2012 - 10:36 AM

Hi Jayqc and shea quay,

If you are not already third party auditors, would you like to be?

Regards,
gcse-fhp


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shea quay

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Posted 26 April 2012 - 05:12 PM

Dear gcse,
no, I am not a third party auditor. I must admit that I've always thought of it as a type of professional critic role, something that always reminds me of the great Theodore Roosevelt when he addressed the Sorbonne in Paris in 1910, and said;
"It is not the critic who counts: not the man who points out how
the strong man stumbles or where the doer of deeds could have done better. The credit belongs to the man who is actually in the arena, whose face is marred by dust and sweat and blood, who strives valiantly, who errs and comes up short again and again, because there is no effort without error or shortcoming, but who knows the great enthusiasms, the great devotions, who spends himself for a worthy cause; who, at the best, knows, in the end, the triumph of high achievement, and who, at the worst, if he fails, at least he fails while daring greatly, so that his place shall never be with those cold and timid souls who knew neither victory nor defeat."


So if I may, I will retire to my home to wash away said dust, sweat and blood and try to cleanse my cynical soul, safe in the knowledge that the same old crap will be once again waiting for me in the morning, and that I will face it with the same bravery and dignity as I did today.

Having said that, obviously if you are offering a job with a salary of 50,000 and a company car I would gladly flush all such fine ideals down the toilet in an instant.



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gcse-fhp

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Posted 27 April 2012 - 06:18 PM

Dear gcse,
no, I am not a third party auditor. I must admit that I've always thought of it as a type of professional critic role, something that always reminds me of the great Theodore Roosevelt when he addressed the Sorbonne in Paris in 1910, and said;
"It is not the critic who counts: not the man who points out how
the strong man stumbles or where the doer of deeds could have done better. The credit belongs to the man who is actually in the arena, whose face is marred by dust and sweat and blood, who strives valiantly, who errs and comes up short again and again, because there is no effort without error or shortcoming, but who knows the great enthusiasms, the great devotions, who spends himself for a worthy cause; who, at the best, knows, in the end, the triumph of high achievement, and who, at the worst, if he fails, at least he fails while daring greatly, so that his place shall never be with those cold and timid souls who knew neither victory nor defeat."


So if I may, I will retire to my home to wash away said dust, sweat and blood and try to cleanse my cynical soul, safe in the knowledge that the same old crap will be once again waiting for me in the morning, and that I will face it with the same bravery and dignity as I did today.

Having said that, obviously if you are offering a job with a salary of 50,000 and a company car I would gladly flush all such fine ideals down the toilet in an instant.



Hi shea quay,

Can I quote you in other posts?

Thanks,
gcse-fhp

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Charles.C

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Posted 27 April 2012 - 11:17 PM

Dear shea quay,

I think yr philosophical endurance is about to be put under test. :biggrin:

Don't forget the Boy Scout's Motto.

Rgds / Charles.C


Kind Regards,

 

Charles.C


shea quay

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Posted 28 April 2012 - 11:41 PM

In my defense.......

Story of my life, Charles!



gcse-fhp

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Posted 29 April 2012 - 12:19 AM

In my defense.......

Story of my life, Charles!

Hello again shea quay,

I am still trying to understand where you stand in the matter of having third party auditing as a necessary role in the assurance of food/product safety and quality. I know you are not a third party auditor and you do not seem to think that third party auditors contribute much to food/product safety assurance.

What exactly is the role you play in product safety assurance, or do you not? What do you think needs to be done about third party auditors and auditing schemes? Should these be taken out of the equation? If so, what do you suggest should be done in place of, or instead of, third party auditors and auditing schemes in order to help companies ensure food/product safety and quality?

Regards,
gcse-fhp

Edited by gcse-fhp, 29 April 2012 - 12:27 AM.

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shea quay

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Posted 30 April 2012 - 08:03 PM

Hello again shea quay,

I am still trying to understand where you stand in the matter of having third party auditing as a necessary role in the assurance of food/product safety and quality. I know you are not a third party auditor and you do not seem to think that third party auditors contribute much to food/product safety assurance.

What exactly is the role you play in product safety assurance, or do you not? What do you think needs to be done about third party auditors and auditing schemes? Should these be taken out of the equation? If so, what do you suggest should be done in place of, or instead of, third party auditors and auditing schemes in order to help companies ensure food/product safety and quality?

Regards,
gcse-fhp


I feel that I have provoked some soul searching questions deep within you, gcse. However, only your God on your judgement day can validate your position on this earth, I'm afraid. In the meantime...

1. I never said auditors we not necessary, merely a necessary evil.
2. I am unable to verify your ability as an auditor, I'm not on your continent. However, I have had some lushes of auditors in my time who have stuck rigidly to the auditor's code of "if I don't have a non-conformance, I can't put in for mileage". This has embittered me.
3. I perform a number of ancillary and auxiliary services to the Company that employ me. For example, to-day I swore at a Frenchman. In French. Though it turned out he was actually Belgian, a Walloon, in fact. And a woman. We did have a laugh about it afterwards.
4. I currently operate to five separate food standards - all vague and non-business specific. Tiresome, and proof, if it was required, of a shady confederation of auditors making up silly clauses in order to justify their existence.
5. I heartily endorse forums such as these that offer practical advice to Quality Managers in promoting food safety and feedback from regular contributors, some of whom may even be auditors!
6. However, all auditors have a price. The worst I've seen personally was in the meat industry in the UK. If they had a score of 82-85 and a North African inspector (this is not meant as racist in any way - just based on my findings), the plant was awful (never eat chicken on a flight from Heathrow).
7. Specific auditing schemes that work with the regulatory bodies for each type of food industry, introducing scientific facts along the way rather than a pithy upgrade of general versions, would not only enhance the food safety and quality of products but also allow a situation whereby both Quality Managers and auditors could progress from low risk processes to high care, rte products, therefore preventing the village idiot from either poisoning the entire neighbourhood or the village idiot sanctioning the other village idiot from poisoning the entire neighbourhood. Also, they would reduce the costs to SME's (small to medium enterprises) in being pro-active rather than reactive to the latest scientific developments.
8. Quality Managers should get tasty sandwiches EVERY day. Not just when auditors are about.

Apart from draconian measures such as making competent auditors financially liable for any food safety issues within 6 months of an audit, I don't think there is much else I can say. Actually, now there's an idea.......


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gcse-fhp

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Posted 30 April 2012 - 08:45 PM

5. I heartily endorse forums such as these that offer practical advice to Quality Managers in promoting food safety and feedback from regular contributors, some of whom may even be auditors!
7. Specific auditing schemes that work with the regulatory bodies for each type of food industry, introducing scientific facts along the way rather than a pithy upgrade of general versions, would not only enhance the food safety and quality of products but also allow a situation whereby both Quality Managers and auditors could progress from low risk processes to high care, rte products, . . . Also, they would reduce the costs to SME's (small to medium enterprises) in being pro-active rather than reactive . . .


Hi shea quay,

Thanks for your response. It provides much to think about. I do like your points that I have highlighted from #s 5 and 7. I hope I am not being too selective due to some biases that I may have.

Regards,


gcse-fhp

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Cranberry

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Posted 01 May 2012 - 07:43 AM

8. Quality Managers should get tasty sandwiches EVERY day. Not just when auditors are about.



...and biscuits. Don't forget the biscuits. Posh ones. On a plate.


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shea quay

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Posted 01 May 2012 - 08:45 AM

You get a plate too?!? I'm getting on to the union about this one!



gcse-fhp

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Posted 01 May 2012 - 12:24 PM

I suspect that the auditors do not demand sandwiches and biscuits. They may appreciate these if you provide them. Such a gesture may even allow the auditors to spend more time on the audit rather than on searching for food nearby if they do not pack their own lunches. This does not eliminate the need to give attention to the 12 helpful audit process rules that I listed in my first post.


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Simon

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Posted 01 May 2012 - 02:22 PM

A good auditor must possess a good sense of humour.
Audits can be enjoyable and productive or they can be a total waste of time.
Thsi largely depends on all parties coming to the table with a willingness to learn, share and improve.

A few thoughts.


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gcse-fhp

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Posted 01 May 2012 - 02:37 PM

Oooops! I forgot one. Make this #13 - The auditor must maintain a good sense of humour.

Thanks Simon!


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Mark H

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Posted 06 May 2012 - 07:07 PM

Hi shea quay,

Can I quote you in other posts?

Thanks,
gcse-fhp



This thread alone confirms the value of this forum along with validating why I read IFSQN daily.

Very best regards from the colonies.

MH





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