· Zero defects

· No human injuries

· No product recalls

· No complaints

· No internal failures

“These are the world-class expectations; the business expectations are even tougher – they want faster product delivery and faster QC testing on top of all of that,” he added. “And they want more efficient processes along with this – the ability to do more with less. They want less incoming inspection. They want to eliminate non-value-added activities. In considering building our world-class systems, we need to consider these business expectations as well.”

Presepe defined a world-class auditing system as an audit system recognized both internationally and by customers as “best in class” that even exceeds their own expectations. These are measured by global standards for food safety, hygiene and quality systems in addition to other new emerging issues. “People don’t necessarily realize that auditing is always against something – it’s audited against an expectation – it’s audited against a standard or a set of requirements,” said Presepe. “That’s where we begin. Higher performance can be obtained by adding attributes of interest to customers as well as critical objectives defined by your company. If you want to be best-in-class, what’s best-in-class for you? Your customers have certain expectations of you.”

Presepe said audits are needed because of increased competition and downward pressure on overhead costs, renewed focuses on risk management, productivity, cost effectiveness and value-added products and services. He said there’s a need to create a means of performing an ongoing self-assessment process and a periodic review. “In years past the customer was satisfied with the quality and safety of the product. Now they want you to take off your coat and see the next layer of clothing you have on underneath your coat,” Presepe said. “This makes it difficult in a way but it makes you put more of your own eyes on your own systems and gives you a closer view of what’s going on in your own place.” These audits, he added, can find problems or potential problems before they become costly. “You’re proactive – the ‘ounce of prevention being worth a pound of cure’ concept holds true for a reason to perform audits,” he said.

To get the most benefit from the audit process, improvement must be a goal, Presepe said. “You don’t just audit to get a nice, pretty audit report to submit to management showing you did 27 audits this year so you earned your pay. What counts is what resulted from those 27 audits? Why are we better? What kind of corrective actions have we taken? Is our risk any lower? Are our processes any better because of changes we’ve made?”

Presepe said knowing what type of audit is taking place (HACCP, ISO, etc.) is crucial. “There’s also proposed legislation out there for nutraceutical GMPs, so if you make products that are being sold to the nutraceutical industry, you can be asked by your customer to be compliant with these proposed regulations which are heavily pharma-based – not food based,” said Presepe. He said customers and third-party auditors will often have their own standards as well. With so many standards, confusion can crop up.

“What Firmenich has done, and these are always a work in progress, is to review its customer requirements for quality and food safety systems,” said Presepe. “Every customer questionnaire that came to us over the course of the last couple of years was assimilated in a requirements document defining what our customers’ needs are.” Presepe suggested each company review its design and production SOPs for failures using industry-accepted criteria such as AIB, FPA and NSF standards. “This is another benefit of auditing because you want to find things that have not become problems yet. You want to eliminate them, correct them and/or improve on them so that your plant will be more efficient. The fewer problems your plant faces when it makes its product, the more product it can make,” said Presepe. “We’re about identifying these problems before they occur.”

Presepe said it’s important to review the requirements placed upon vendors. “Basically, in order to have a world-class system, you have to define your own world-class standards. You’re taking pieces from all the things that are out there that meet your current business demands. And you’ll have to review that from time to time as you add clients, as your business environment changes or as regulations change.”

Presepe spoke about Firmenich’s audit approach. “Standards are applied consistently throughout the entire organization; vendor controls, product design, manufacturing, packaging and delivery – we have consistent expectations through all of these areas,” he said. “In auditing, we don’t often talk about design control but if you design a product that has a failure built into it, you’re going to see it when you produce it.”

Presepe cautioned against double standards. “Vendors must not be held to a higher standard than your company,” he said. “What we implement at Firmenich is something we call a three-tier model, where we have the supplier/subcontractor audits at our base. For us it’s a very important aspect of our business. We think we’re controlling the quality of our raw materials when they come in but the quality has already been controlled before they ever got to us since they’ve been in the complete control of our vendor – how they managed it, how they produced it and how they took care of their equipment and their cleaning as well as our packaging vendors.”

Presepe said many companies can’t or don’t perform enough audits. “People generally don’t have the resources to do it or the time to do it and they’re trusting the purchasing department for monitoring the performance. But I would submit that if you knew more about your vendors, you’d be very surprised. You may even find out you’re buying from vendors who are buying from vendors who are buying from other vendors. Don’t assume your vendor is the primary supplier and knows exactly how that product is made,” he cautioned. “You don’t know unless you go with a list of X number of products and specifically ask the vendor if they produce all of this. They may look at you and say, ‘Well, this one here is a resale item for us.’ So you don’t really have the controls over your raw materials unless you go out and audit your vendors.”

He said Firmenich also has an internal audit program which looks at the design of its products and at the manufacturing and production - food safety – hygiene – and sanitation. “But you have a whole host of other systems out there that are going to guarantee whether or not it comes out right. And a standard like the ISO 9000 standard would be one that reviews different systems in your plant but could be used by your internal auditors. We like to compliment that with the roof of the house being our third-party independent audit systems, topped off nicely and driven by our customer requirements – the customer being the most important aspect in defining what they want from us.

“You’ve all heard of Current Good Manufacturing Practices,” said Presepe. “What we’ve done at Firmenich is create FGMPs – Firmenich’s Good Manufacturing Practices.” For example, he said, Firmenich took good manufacturing practices from a variety of sources – CODEX Alimentarius, European food law, etc. – and defined what it is Firmenich should have. “We’ve broken that down into a GMP checklist and we use that checklist systematically in all of our facilities,” said Presepe.

Another process put into place at Firmenich is GTPs – Firmenich’s good transportation practices. “We’ve defined our expectation of transportation companies who never damage packaging and always deliver on time,” Presepe said. “We can now audit systematically these transportation companies against a standard we’ve defined.”

Presepe said when employing this kind of measuring and using point scoring, a company can keep track of performance. It can be done quarterly or once or twice a year and by site locations so one can compare if anything is slipping or if it is status quo. It also allows the company to monitor sites that have had problems to assure there have been improvements.

Presepe spoke about changes in the way some audits are conducted. “The classical method is that you audit against a known standard. You make observations. You send out an audit report with findings and then you ask them to send you an audit report back and they tell you within 30 days they took care of it. They always say they took care of everything you pointed out but that’s not always the case.

“The new model includes something different,” Presepe said. “The new model says you audit your vendor against an appropriate standard which means that’s something you’re going to define. If you’re going to a chemical vendor, you can’t hold them to a HACCP standard. You can hold them to product protection but they’re not going to build a HACCP plan at a chemical plant with no microbiological risk. You have to go to them with a set of standards.”

The new model, he said, can result in less testing. “If it’s a pure chemical and somebody’s going to do a GC and it has to be 99.9 and you audit them and see that they have GC capabilities and their technicians are qualified, why are you re-running it again? A better method would be to do an identity check or another quick test when it comes in – something that is shorter than an hour or half-hour GC run.”

One should also audit against plant and product failures, according to Presepe. “You have to get down to the plant floor level and understand your standard operating procedures,” says Presepe. “I run into this challenge all the time: How much documentation should we have out on the floor? How many things should we write about? ‘Why do we have to write so much? We have the same guy doing the same thing for 30 years,’ I hear. I reply that ‘if you don’t write it down the way you want it done, then you have nothing to check against to see if it’s being done that way.’ You have to prepare information on the plant floor in detail.”