How to Prepare for an Unannounced Food Safety Audit

How to Prepare for an Unannounced Food Safety Audit



I mean my name's Simon simply from the international food safety and quality Network welcome to edition 71 of the food safety Friday's webinar program it's good to see you all in the sidebar they're saying good morning good afternoon good evening from all over the world as usuals nice of you with us today wherever you tread today's topic is how to prepare for a unannounced Food Safety Rd always it frightening to you have you already had one are you brave enough to take one on anyway lens deed from AIB international is going to be discussing the subject today given us some tips on what we need to do to be 24/7 365 days a week prepared for any type of our day just to say obviously some of you know about the sidebar in the sidebar you can type in your questions and comments throughout we'll be running some polls at various points during the webinar and we'd like you to vote on that and put your comments in and also we put in some offers in stay at the norm you can see they're probably next week's webinar advertised which I'll tell you about in a little while today's webinar is being recorded and all registrants will receive a copy of the slide deck the video recording and the certificate of attendance so if you do miss a little bit if you have to get called away on an emergency R or whatever then don't worry you will we will follow up afterwards so it okay at this point like to introduce you today's speaker Len steed can you switch your webcam on Len if you if you're there yes I am Simon good moring how you're in good thank you good good and where you dialed in from today Len I'm in Manhattan Kansas right and is that where you're from is that where you're at you actually live no I actually live in Pennsylvania right in the Northeast you have the US yeah and you're taking a little brain from a bit of a marathon training session to be with us today yes I am I'm out here on a three-week training mission yeah first week is down very good one down two to go and a nice little break to have a chat with me and the audience a so ok if you want to get your slides ready and get them on the screen share I'll tell the audience about next week's webinar Glen okay in the sidebar you should be able to see a picture of it's actually George howler who is a CEO of safe food 360 and the topics validation of cleaning programs it's a requirement of GFSI standards and next week George going to be telling us a little bit how we can meet that requirement so ok so sign up for that now if not just respond to some of our emails later I'll be joining in with the polls and back with the Q&A later but for now I'll hand you over to Len back on how that's you very good good day everyone today's topic is going to discuss how in an organization can analyze its present position and transition to a food safety level that would allow them to have unannounced audits I think most of us know that if you are prepared 24/7 your regulatory and third party audits will be a lot more successful this presentation will look into some of the underlying factors that would enable you to raise to this level of preparedness and what conditions might undermine your ability to transition to unannounced audits so let's look at some of the objectives and discussion points we are all familiar with unannounced audits and announced audits the rear there are some tangible differences we are going to look at the aspect with regards to comparing regulatory vs. third party audits and then we're also going to look at any of the factors or conditions that might be affecting your food safety culture at your point for example we're going to look at scoring most of the audits third party have a scoring system to it if we have a lot of financial incentives and bonuses tied to the score there's a likelihood that there may be additional preparation for the audit so we're going to have a poll question about this we're going to discuss it and we're also going to look at the level of preparation are there companies that tend to spend a great deal of time preparing as compared to the ones that have a very minimal level and again that impact on your food safety culture we're also going to look at food safety messaging to your company personnel when you have announced versus unannounced audits and we're going to have an evaluation in other words how could you pull and look at the an interview and talk to your employees about unannounced vs. announced and then for those that want to transition we are going to have a discussion about that there are some facts about unannounced audits they are more and more common I did a Google search the other day and there's just about every major industry biomedical pharmaceutical are going to unannounced audits so this will be applied to the entire supply chain but there's also some reasons unannounced audits are not good for some companies they can be very disruptive in other words if you don't have key personnel there to actually feel the questions and explain the processes and programs it can disrupt your normal business operations also if you're not prepared if you were to have an unannounced at it and you didn't have your systems in place it could reveal some significant GMP issues whether they be third-party or regular taury audits it is obvious if bad situations are observed or to use the regulatory terms unsanitary or violative conditions that would adversely impact your organization so really what we're looking at here is preparing and if you decide to go down the road of unannounced audits you're likely going to have to have a procedure you're going to have to test it you're going to have to live that type of program and as we all know with any changes input in planning and commitment from senior management is essential so let's look at who controls the audit schedule in other words when you have announced or versus unannounced audits many times when I've been working through the years you would like to come in and the customer oh say please don't command it's the busy season well that would be probably the most logical time to come in because that's when you're making most the product if we compare this to regulatory they can come in any time I've heard some excuses with regards to training it's a busy week but then again we look at regulatory and they can come in any time oftentimes there are some legitimate issues like vacations but the fact the matter is is that the regulators can come in any time and then we look at key personnel in many companies the QA manager or others are the lead person and if they were out the company would have a lot of difficulty managing accessing records and completing the audit effectively there's also companies that say we're not ready and they need more time to prepare which kind of tells you that they are spending a great deal of time preparing for the audit and then I've had situations where they would prefer to audit on one shift when in fact the regulators can Aude it on any shift as long as you are processing one thing I found that is very critical is that there be agreement within the organization with regards to the severity of plant conditions and issues with regards to GMP s this is not the only way to do it but this is just an example for the presentation most people would call unsanitary or violative conditions critical and this would be understood within the organization that it is an unacceptable risk in other words it could be a class 1 or class 2 recall and most of us know class one recall means typically death or injury also there could be major findings which are a potential or actual regulatory issue that could allow for unsafe food and then of course minor is a potential or actual non-compliance with a GMP requirement that would typically not affect food safety so let's continue on with our comparison for hazard severity within your organization if you look at the regulator's their enforcement clauses are 402 a three and four 402 a three is when the product is contaminated there's no question you can actually see it but the enforcement clause that they tend to use most of the time is where the food has been held prepared or packed whereby it may have become contaminated and the regulator's have a different view of contamination as composed as compared to some of the third-party but when we look at severity it will be divined by the third party audit criteria also on a third party audit if you disagree with the auditor you can discuss it with them in fact usually there's a system in place where you can actually object to the audit finding and challenge it with regards to the severity of the issue but when you look at the regulatory aspect they always fall back on that section 402 a 4 whereby the food has been held under conditions whereby it may have been contaminated and this would be mold along the ceiling wall junction which could be a long way away from a product zone area so there are some significant differences with regards to how the regulator's look at something and your ability on a third-party audit to actually go through and challenge some of the findings so how important are audit findings if we look at a third party you can request a review you can also do that with a regulatory inspection but it's likely you be bringing your lawyer with you because the regulator's go through their own internal review process and when they send you a letter or issue a Form 83 they're pretty much behind those findings in a third party you can strongly disagree in fact in some cases you can actually have the auditor replace or you could actually go on and decide that you would like to use another third party audit group but in all cases third party or regulatory you would have to do corrective action and again corrective action would be reviewed by the third party group but it wouldn't have the severe impact of a regulatory person reviewing your corrective action because if your corrective action was not done effective it could be an adverse event for your company so now we would like to have a polling question and the background here is we would like to know the emphasis and the plants core and financial incentives if these were in place is your third party audit score tied to incentives okay yeah Len I've set the poll live in the sidebar the question is is your third party audits incentives and simply yes or no and Bolton is coming in and yes shuttling around about 15 and no of 20 80/20 yes 18 oh yeah that's how it's gonna be now it's about 25% yes and 75% no huh is that what you're expected to say Len uh no that's not what I expected to see because it's it's my experience working with a lot of different companies particularly larger companies that the score for a third party audit or GMP inspection is Twitter tip about twenty to forty percent of the person's bonus but again I'm certainly don't disagree with the poll findings but that's not exactly what I've experienced okay you can move on now Linda thank you okay so now I would like to look at the emphasis of plant scoring if financial incentives are tied to it and I would like to look at the level of preparation in other words if you were to have a third party audit would you have extensive preparation would you classify it as significant or moderate or in most cases you would do little or no preparation for that third party audit okay again I've loaded the poll in the sidebar and the question is what level of creation do you apply extensive significant moderate or minimal to none and hopefully you can see that extensive is around 27% significant 50 45% and moderate 25 and then just a few minimal to none so there is obviously quite a lot of work to do in order to prepare for an audit okay so that is more in tune with what I expected because it's just human nature to to prepare for these audits so what I'd like to do now is talk about if any of this preparation can affect the plant culture these are things or typical activities that I've seen that go on prior to audits in fact I've actually worked as a consultant helping companies prepare for audits typically what you'd see is pre audit of the key records and if there's issues found there our Corrections made there is also a survey of the prior GMP issues with the building and equipment to repair or fix deficiencies that would severely impact the scoring and also you see a preparation preparation or coaching of personnel for interviews in fact in extreme cases I've even seen people asking where you're going to go next so that they can have people quote scout ahead to see if they see any issues that they would correct prior to you getting into the room and then there's also the fact that many people try to control the audit in other words the auditor really relies on the cooperation of the company to access records and to go to certain areas and what I found or seen is that some companies that are being audit would would actually try to control that situation so what I'd like to do is look at evaluating your present position in other words with the information we've discussed is there any impact on how your employees would view the unannounced versus the announced inspection and it's my experience that many companies conduct interviews obviously there's good communication but many companies have always have used anonymous polling and that's where they can ask the plant employees anonymously what their opinion is of the the food safety culture the GMP compliance and what we're specifically looking at here is doing a lot of preparation actually beneficial for the organization because what I've seen is it kind of presents two sets of standards in other words if you are in the category and prepare significantly or extensively you're likely to be operating at one level of GMP compliance prior to the audit and during the audit and then your GMP compliance will actually degrade and the other thing to look at is does the scoring in your third party actually predict your success for regulatory compliance so really is it beneficial to do this preparation to try to control the audit and then with this information you can actually go back and see is there any need to change would unannounced audits actually allow you to have a more consistent food safety system so what I'd like to do is have another polling question with messaging to your plant personnel and the question is does this affect the consistency of your employees view on your GMP compliance at your plant is it positive or negative okay again I've said all along the sidebar a question does this affect Presidency of employees views on food safety positive on negative and we can see around 85 percent positive and 15 30% negative so the vast majority positive yeah uh yes I agree with that completely and certainly the polling speaks for itself but the feedback that I have gotten from some of the mid-level to upper level managers is that some of the employees feel that the company is operating on two levels in other words uh for the preparation in the audit you do things that you ordinarily wouldn't do you have a higher level of awareness for food safety and then in some cases you would slide back to business as usual so again the polling speaks for itself but uh the issues I've seen is that operating on two levels is a concern for some employees not only at the lower levels but also at the upper levels so what I'd like to do is have a little open and honest discussion about some of these discussion points we go over and ask the question what does audit preparation deliver what I found is that it tends to obviously allow you to get a better score but it does present some issues with regards to consistency if you would pull your employees and they are satisfied with the level of preparation and they don't think there's an impact well that's all well and good but if you went to unannounced audits you would be ready 24/7 and and that I believe is the goal of many people and certainly that is the way that industry is going so for those that are seeking to change what I would recommend is that they would at least go to unannounced audits for your internal audit program and you need to be looking at how we're going to do this and the concept we're trying to do is to be in a perpetual state of readiness and if we do this it's obviously going to cause or require more resources and planning and also to have a procedure in place if we do go to unannounced audits I can almost guarantee that this will mitigate many of the adverse impacts that some companies experience when they go through this cycle of preparation and only do anounced audits so if we're trying to effect meaningful change you would have to obviously have impact from your senior management they would have to provide the resources necessary for all this cross-training so that when people were out you would have backups that would be able to go through the quality go through the processing the maintenance and engineering to field the questions with regards to the third party audit criteria but also you would have to be in a state of preparedness on a third party so the unannounced audits would be good but you need to go through and do a critical review of your food safety system taking you back to the findings in other words the severity of findings you would have to establish that critical no debate issue that everyone would agree that this is a significant audit finding and would have to be corrected you would also have to look at your corrective action system what I found in many facilities is that you have repeat corrective actions so you'd have to have an ironclad root-cause investigation to correct these and not allow them to happen again most companies if they go to unannounced audits they actually set up and do their audit preparation typically quarterly in other words we're using that same model for preparing but it's ingrained into the system it is done on a regular basis typically quarterly and all internal and external audits will be announced there's certainly a transition we've had several large companies come to us and they actually started with their GMP audits unannounced and then they transitioned to having their third party audits unannounced so for those of you that are considering going to unannounced audits we have another polling question and these are the options here what are the plants situations that could prevent adopting and unannounced on it okay yeah I've loaded that in the sidebar of course your plant situation could prevent from adopting unannounced audit resource is not available company reluctant to change plants core is viewed as most important and finally management commitment for unannounced audits is not supported as a supposed land multiple of those actually you know oh my god yes yeah by the way you're forced have to pick one only and how it's settled down is management commitment is the highest with 33% resources not available 29% which is tied to Missouri commitment I guess yes company reluctant to change 22% and plants for his view because most important 18 percent so yeah what does that look Lunn yeah that is uh that's almost what I expected if you were to combine the the resources not available and the management commitment for unannounced are has not supported those are really connected because if you were to commit the unannounced audits you would be having the unannounced audit procedure in place you would adopt a a system where you would prepare on a regular basis of typically quarterly to have audits you would do your cross-training so that essentially you would be prepared for an audit at any time so so that really is is kind of what I expected okay all right but no three to me though so what I'd like to do is summarize for those of you that are thinking about moving onto unannounced audits to improve or impact your food safety culture obviously again senior management is the key so they would likely have to spearhead that many companies now are requiring unannounced audits along the food chain that would your supplier even the supplier to the supplier the receiving entity the customer and even the customers customer unannounced audits are very applicable to co-packers and suppliers and it will definitely change the culture of a company the reason I think unannounced audits are very good because it tends to align your preparedness with regulatory expectations this is particularly true if the severity criteria is understood and agreed upon within the organization so if you were to go down this road you would require training you would have to have a documented procedure for unannounced audits and you would have to have a system for testing this in fact many companies now are doing FISMA related unannounced audits because as we all know companies need to be prepared all times so if you set up you'd have to do a review of your risk-based food safety systems you would replace that announced audit preparation cycle with the unannounced you would critically review your corrective action and make sure that there are no violative or unsanitary conditions or repeats for your GMP compliance an effective unannounced audit program will mitigate adverse impacts and that is primarily tied to companies Beckett and regulatory issues they have problems that they have contamination in the marketplace so if anyone has had a form 483 or warning letter from the FDA or from the state they understand how an adverse impact can economically hurt the organization so in the end you would replace that preparation cycle and just do it on a regular basis so with that I'd like to ask if there's any questions or comments right yes thanks very much flag if you could stop sharing your PowerPoint now and then we'll go to the Q&A there are some questions that been coming through so we can move to them I know switch webcam home as well there we go okay thanks very much a nice little primer there land and just to get the discussion going Simone says isn't a financial incentive a bit counter a counterproductive according to intrinsic motivation yeah that's kind of the point that I was trying to make with some of the polling that I did again I'm not saying that that all companies have financial incentives tied to the scoring announced audits but I do have to honestly say there are quite a few and when financial incentives are tied it's human nature that people are going to prepare and in many cases prepare extensively which really isn't a good day a good idea for the organization because it essentially says that we can operate on two different levels and what I've found is that you know people within the organization not only at the lower levels but at the mid and upper levels understand this and it's not it's not healthy yeah okay Lonnie is saying with with sqf we get to announced and one on annouce these are considered third party audits right yeah yes yeah that's it yeah go to do let's have a look Simonne again the question is what I think this is related to the poll this what do you do if you don't get the resources so if if if you're not provided with adequate resources to achieve the quiet level of food safety well if if you follow the presentation what what I would suggest is that you would do some polling or interviews of your employees and actually find out from them if they they believe that you the organization has a good food safety culture just for an example many people use Survey Monkey their suggestion ox there are others where you can anonymously poll your employees and like most people they I'm sure they'd be happy to share their opinions with you and I actually know companies that have done this and they get some very interesting feedback because they notice the level of prep raishin for third party audits tends to be quite high where where things that ordinarily wouldn't be done or postponed are done because you know you're having the audit and you want to get a good score and and really I would like people to look at is your scoring in your third party auditing actually indicative of how well you're prepared for a regulatory audit and what I've seen with these different cycles where you prepare and then you go into this other level it's it's not good for the organization yeah okay Bruce would you consider a 90 day window for an audit I was unannounced so actually I would tend to say no because I've been down that road before and I tell you some interesting tricks is that the people at the plant would actually call around hotels and they would find out when the auditor is coming so even with the quote unannounced at it I found many times that the company actually knew exactly when the audit was going to Kirk oh I don't know there's all sorts of sneaky ways I suppose Devlin really Stuart wouldn't wouldn't continuous training and assurances of good work references potentially unannounced others be considered preparing although it's not making sense to me that that's with that community sure does it well well I can actually I can actually address what we were trying to convey is that everybody knows that that people prepare for audits so so what the model I was proposing actually it's not mine it's been out there for people that go to unannounced audits and really this model comes from the pasteurized milk ordinance is that they're required to do quarterly reviews where they go through they look at the records they review their corrective action they they look at their management commitment and projects and they would have that done on a scheduled basis so essentially what they're doing is replacing that announced audit preparation with being prepared all the time yeah I know also lenders some companies as part of their internal audit program for example take let's say let's say with BRC it could be any standard but let's say it was BRC they take all of the requirements of the standard and and put them into a schedule and perhaps do some of the higher risk ones more frequently but but at least at least under and so that you are always then preparing yourself incrementally for that for that audit that's exactly right and with the new regulatory requirements coming down the road with the Food Safety Modernization Act which all countries are going to adopt something similar is that it's really asking you to know the most critical food safety issues at your facility and those would typically be audited more frequently but in the least amount of application a company should really consider going to unannounced at its internally and and who knows that that is the could could be the start in other words you're prepared internally exactly and I think a Adria adriennes said that when you say to have internal on and our audit is it for the preparation of when we have the unannounced FSF is marar sqf yeah of course I mean there will always be some tidying up and clearing of working progress and and painting that floor that you meant to pain that's not really a food that's not really a food safety concern but you know just putting a little bit of spit in polish but it should be minimal so for any type of audits and it itch should because it's it's not the right right thing to do and and like I've said people in the organization notice stuff like that and then of course they notice when things tend to slide back to where they were prior to the preparation okay Camille we just have an unannounced third party all day how can I assist in getting more buying from senior management in terms of resources and support once corrective actions outlined so well you know that's that's why I had that slide in the beginning where you need to have an ironclad or no debate agreement on what our significant findings and by significant findings I mean ones that will be an obvious regulatory issue and most of us know that if you get caught with you know condensate on Ernie Rover product zones you know contamination and that's why I pulled out the may have clause in Section 402 a four because that's the the the idea of contamination in a third party audit is much different from what the regulatory people believe their idea of contamination is much broader to the point where if they saw contamination in the same room they many times would assume because it may have become contaminated they will put it down as a critical finding okay okay do you think tea fees of teas do you think it's frequent enough that GFSI FS SC and sqf acceptor now do unannounced but only one out of three orders well you know you always have the option of going to three unannounced no you see what I'm getting at is this is a start and everybody that is in the audit game as I say no that there is preparation now whether it's significant preparation or minimal that's that's really the question and if you go on an unannounced audit usually the results are going to be much different if you didn't do that preparation cycle so it's almost intuitive that you would be better off going to some type of unannounced at it and be the same type of manufacturing plant 365 days a year it is a difficult decision though because for example I am familiar I think a bit with the BRC grading so let's say a double-a is announced but you get a double a bought a B star so you get that little star because you've had an unannounced but to your customers you know whoa well you've got a B that you don't put up under study protocol and you know what he's demanding familiar house you know and how difficult it can be they just see a beam stead of a double-a you say yeah but it was unannounced yeah yeah yeah well I'll tell you what I would rather be a B throughout the entire year and instead of being the double-a and then going down to a C or lower but again I I think in the polling questions to your in your company and reassessing financial incentives is that it's it can be a detriment to a company when they get into this preparation cycle and scoring is the main objective so really what we're asking people to do is maybe go back and and take a look talk to your employees at all levels and and see if there's a need to rethink this we lost you for a little second there for some reason there's another instance of oh it's me I don't touch it no no no I think my connection must have just dropped for a little second I have a look anymore in the sidebar today if you can see any there ah Federico does the concept of one announce that it's really aligned companies is seriously who seriously care about food safety okay I I think I got that if there was a decision in senior management that they wanted to be prepared every day the the unannounced audits would serve them well because they would have gone through providing the resources the cross-training necessary so there would be coverage to be able to field and unannounced Aude it oftentimes in companies there's keep you personnel in other words the QA manager or other individual responsible for audits it essentially is running everything and without them being there the company wouldn't be able to produce the records and in some cases even explain how the GMP programs are executed and how the KPIs are interpreted so really what I'm saying here is that you would have the ability to have anyone come in at just about any time and have the confidence that your level of GM PS would always meet customer and regulatory standards yeah and ultimately it's about the safety of the consumer at the end of the day and you shouldn't be switching on and off procedures but to keep them safe and healthy right Brenda my facility has been BRC on and ours for three years now and it keeps you on your game excellent and I would agree with that a hundred percent good for you Irina hello could you please elaborate a bit on the ironclad root-cause investigation ironclad root-cause investigation well I know everyone has root-cause investigation but when you have repeat issues again you're not addressing the absolute root cause so in other words when I've reviewed as an auditor but also come in as a consultant I would actually look at their their GMP issues not only operational practices but building issues and if I see a pattern or trend I'm going to bring this up and I find this in most companies in fact in our training this week we went through analysis for a company and they have the same problems over and over again so ironclad means is that you're going to have to face these these problems that are occurring over again whether it be operational building equipment related and correct them so that you don't have problems with the regulator's yeah okay thanks London if the I don't know if you know it ah unannounced food safety Oz it all it's only tied to private standards and regular its regulatory authorities well really what we're trying to get across and the presentation is that there's there's lots of GMP standards out there and when you have an issue and found on a third party audit you can discuss them debate them you can disagree with them and then we have the other side of the fence in the real world where if a regulator came in and they found something typically there's not going to be a lot of discussion in fact I've seen companies that had a cop of significant regulatory issues and if you were to compare those issues to the third-party accreditation those would be likely be changed or modified so again the point I was trying to make here is that there's a stark difference between some of the regulatory views on contamination versus what you would see in a third party audit criteria okay any more questions ladies and gents before LAN hostile Olivos we've got a few more minutes with had a commenter in the sidebar and I've been feverishly deleting the comments because it's just spam apologies to the legitimate commenters in the sidebar but unfortunately I can't do anything about it okay in regards this termination of the plan what are some of the key ball in wicked artists today um yeah my audio kind of went out on that a little bit Simon oh yeah it's just Abner is asking in regards to Sanitation of the plant what are some of the key points audit is look for in regards to sanitation oh okay well well first of all if you have a risk-based food safety system you've already gone through in your hazard analysis and decided what is your critical cleaning in other words you know how long you can run a process line before you typically would get into indicator organism issues and then potentially pathogenic bacteria but cleaning would also apply to your allergen your allergen changeover cleaning the auditor would first of all ask you what is your critical cleaning and if you couldn't respond and tell him what your critical cleaning was it would tell them that you haven't really analyzed this so that's typically where I start in other words do they know what is critical for food safety that makes sense Michael but do you believe that Lean Six Sigma principles help to get plants audit ready anytime I'm going to answer that yes and no and then I'm going to get into the fact that in lean which I support in fact I'm a member of the lean group at American Society equality but also what I find gets in there is the term value added and just this week at the training I was performing one of the students said that many of the upper level management people don't view sanitation as value-added and in some cases sanitation isn't value-added because regulatory compliance is not meant to be value-added mmm it keeps you out of trouble from an adverse impact recall losing millions of dollars losing customer confidence and perhaps market share so lean is very good but it shouldn't be in conflict with your known regulatory requirements okay great Ella I am putting you to food safety can you please let me know what is 402 brackets a three and four yes and I know much of this is us-centric in other words this is what the FDA does and that's not what everyone else in the world does but these are the two enforcement clauses that the FDA uses and the distinction was is 402 a 3 is where product is contaminated its putrid decomposed as pathogenic bacteria but they tend to use the 402 a 4 clause whereby food has been held packed or prepared under conditions where by it may have become contaminated they use that enforcement Clause almost exclusively okay thank you Declan is asking is there a difference in results between announced competitive unannounced audit performance I can honestly tell you that there is because as I mentioned we have several companies that have decided that they are going to unannounced third party audits typically companies start out with the GMP and they have noticed a significant improvement with regards to day to day conditions this company actually modified their incentives to be broader and in other areas so that it took the importance of scoring off and it didn't allow the plants or have the plants prepare so the unannounced audits in my estimation and my experience has had a very positive effect on most companies okay Kim is asking besides using a poll are there any other options I did take talked to take seen image with to support unannounced auditing okay well well what I would do is actually do the survey poll of your employees and again I would do all levels and I would even include senior management and then I would bring out the points and the fact is your company extensively or significantly preparing and then with that information you can show that you do have a variation in your GMP compliance and let's face facts senior executives are smart people if you have variation in your GMP compliance you run the risk of having the quote adverse event which means having a regulatory issue which always is an adverse impact on a company okay none again what what is in order to look for in a master sanitation schedule boy you're asking these good questions today well again I I would go back to the critical cleaning first of all has a company do they know what their critical cleaning is have they prioritized and used their resources so that they could accomplish their critical cleaning where if they know they don't clean something in a certain frequency then they are going to run the risk of first of all usually having quality issues but then again if those bacteria can grow and you're making a ready-to-eat product then you can likely have pathogens grow so everything's relative there's conflict as you know within a company where you want to run the equipment all the time hopefully downtime and cleaning is not looked at as a non value-added because it really isn't it's keeping the company healthy it's preventing any adverse effects in the marketplace and that's where the agreement on the significance of findings and conditions it really needs to be a no debate issue within the organization yah-hey always asking whether unannounced audits are internal or external they can be both absolutely and that's why for those companies that are thinking of transitioning you would adopt your internal audits unannounced and that would be a start in other words I've even found on internal audits that certain departments will prepare if you're a large company where you have internal auditing going on at several different sites because you're using different auditors they if they're notified they will actually prepare for the audit yeah on false we have deleted it coming by accident and but it was a good one and it said about getting management baton should-should or our GFSI Stander's including more about senior moment commitment and the culture of the organization to actually building some requirements and auditable requirements along those lines okay could you repeat that one more time so I'm gonna cut out on me again yeah it was a comment that I've deleted so I can't read it but just remembering back and it was about should GFSI standards include more about more required senior management building and demonstrating a food safety culture yeah I think that they should drill down a little bit uh many times I I know during audits that I've done for I've been an auditor for 38 years is that they always tend to put things on QA certainly you may meet with the site executive and talk to them but many times if I wanted to be tough on the audit I would actually interview and look at the knowledge level of the site executive in other words do they know what a true food safety issue is and and there are some times when I in conjunction with with finding bad issues in the plant I would actually link the two so that senior executive needs to understand this stuff yeah okay okay I think I'm not no Len I think believe it we're approaching the hour mark now you do a great job with answered lots of questions and give a lot of food for thought about on announce Dobby so thanks for your time today Len absolutely Simon thank you much appreciated from myself everybody watching this now and we will see the recording and everybody the IFS comments so hopefully we'll see you again on the 2018 program you bet

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