About 'international standards on auditing'|Int’l Audit Groups Say PCAOB Proposed Confirmation Standard Falls Short on Convergence
SQF 2000 REQUIRED DOCUMENTATION SQF 2000 is the food industry's response to ISO 9001. The food industry has probably been controlled and regulated as stringently and for as long, as any industry, if not longer. The style of requirements and auditing, however, has concentrated on what is called Good Manufacturing Practices (GMPs). These are guidelines and rules on personal cleanliness, integrity of the facility, upkeep and so on. Typical Quality System standards include so much more than GMPs. One of the leaders was and always has been, ISO 9001. It came out in 1987 as the answer to the multitude of differing quality standards first tier OEMs (Original Equipment Manufacturers) were subjecting their customers to. In the automotive industry alone there was upwards of eight to ten different standards a company would have to prepare for. Once they were ready, they would have to entertain a team of auditors for two to five days or sometimes even more. It was really getting out of hand. This was certainly a situation that called for the expertise of the International Organization for Standardization. I won't go into any more of the history or background of this organization or of the origin of SQF 2000. Suffice it to say, the food industry now has a very capable Quality Management System and they are applying it across the board. Like I said, the food industry has plenty of experience with following standards and documenting what they do, but they have very little experiencing when it comes to documenting an actual Quality Management System (QMS). As an example, a typical QMS will require from 20 to 26 different primary activities or processes. These will range from Management Review, to Supplier Approval to Internal Audits; most of which the food industry may have had in place, but there approach was not documented or structured. So now, with SQF 2000, the food industry is being asked to structure, define and document their approach to the same things ISO 9000 has required other industry to address for years. For the food professional faced with that task the question must be "What?" Fortunately, SQF, as do all other major Quality Standards, has a very thorough guideline and set of requirements for the practitioner to review and follow. It is laid out much like the ISO standards. It also includes GMPs and what is referred to as "Prerequisite Requirements." Some of the Pre-Reqs are also included in ISO 9000. All standards get their requirements across by using the word "SHALL." Wherever the word "shall" appears, you can expect to see at least one thing that has to be done. In ISO 9001 the word "shall" introduces about 350 individual tasks to be completed. In the automotive equivalent of ISO 9001, called ISO/TS 16949, there are about 750 individual things that must be done. In SQF 2000 there are a whopping 1100 specific tasks on the to-do list; clearly the most in-depth standard of them all. What must be done to satisfy these 1100+ tasks, or requirements or shalls? Well, the first thing is to establish the documented system. In fact when your registrar, the organization which has been selected to handle your registration pursuit, sends out the auditors, they will come first to do nothing but look at your documentation. They won't even look at records. They want to look at nothing but how you have documented what must be done. ISO used to use a phrase like; Say what you do and do what you say. In other words, document all the activities you put in place to help satisfy SQF then make sure you are doing whatever it is you have documented. This will indeed be reviewed on any and every audit, believe me. Now, what must you document for SQF? Unlike ISO or ISO/TS, SQF does not give you any suggested number of documents or recommended places where documents would be advisable. Instead they use a key phrase to point out when and where you need to consider documentation. That phrase usually goes something like; "The methods and responsibility for ............ shall be documented and implemented." The topic to be documented appears where I have put the series of dots. This sentence is used all through section four of SQF. It isn't used in section five (GMPs) and is used about half the time in section six (Pre-Requisites). That means you need to prepare to document everything in section four (ISO like requirements) and in about half of the requirements in section six. There are also some requirements in section seven, but these are specialty requirements and you will have to sort through them to see which ones apply to your company. In addition to section four, the ISO like requirements in section six are the ones you will need to document. Things like; 6.3) Training of Personnel 6.4) Calibration of Equipment 6.6) Premises and Equipment Maintenance and so on. You will be able to tell by finding that give away sentence from above. If a section of SQF does not have that sentence then you do not necessarily have to have instructional documents for that section. Don't let that little fact sway you from at least documenting that section. For instance, section five is all GMPs. You will not have to document how you assure employees wash their hands properly or how you restrict what they take into the plant, but you still need to document the GMP requirement. You still need to have something that tells employees not to chew gum in the plant. You just do not have to document how you make sure that rule is followed. The documentation aspect is not going to be that difficult for you. The first thing you need to tell yourself to do though is to read through the standard. Highlight all the times the word SHALL appears. Then read it again and highlight all the times the documentation sentence appears. Then read at least once more and highlight, in a different color, all the things each shall is telling you to do. If you can complete this exercise you will be well on your way to knowing what the standards are saying and knowing how you are going to have to document your company's intentions. |
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