Tag Archives: certification

Gary Smith, Eurofins’ Food Safety Systems

Moving from GMP to GFSI Audits

By Sangita Viswanathan
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Gary Smith, Eurofins’ Food Safety Systems

Ask any one in the food safety and quality sectors of the F&B industry and they all talk about one uniform concern: Audits. The sheer number of audits, supplier audits, GFSI audits, FDA audits, unannounced audits, the work involved in preparing for these, and the possibility of still things not working as planned on the actual day of the audit.

Dispelling some of these concerns, Gary Smith, who leads the strategic development and oversight of Eurofins’ Food Safety Systems division, including auditing, certification, and training programs, spoke to Food Safety Tech about how companies can be better prepared; challenges in moving from traditional GMP audits to GFSI recognized certification audits; role of management; and what do you if you disagree with the auditor.

Food Safety Tech: What is the biggest challenge for a company moving forward from traditional GMP audits to GFSI recognized food safety certification audits?

Smith: A good GMP audit program has probably got about 80 percent of the full GFSI scheme. It’s a great precursor. But there are some aspects that are not addressed in GMP audits which are facility-specific, such as would we know if the floor is in bad shape etc.? With GFSI you can’t have any non-conformance. Internal audit programs, corrective action management, root cause analysis, all of these are a must for GFSI. So it’s much more advanced than what’s required in GMP.

The audits are also difference from a validation stand point. For instance, with GMP audits, you need to have six elements of a Pest Control program and a facility can say, I have all six, so I am set. But with GFSI certification programs, you need to have these six elements, but you also have to prove that these are effective.

GMP audits provide a snapshot in time, a look behind the curtain to make sure you are following all the requirements. With certification, it’s a more consistent and continuous process – you are always looking for ways for improvement, and ensuring the standards and systems are working the way they are supposed to.

FST: What is the role of management in the audit process – whether GMP or GFSI?

Smith: There’s a big difference when it comes to management participation with both these sets of audits. Management needs to understand that with GFSI certification, management is required to have a culture of continuous improvement, where they are constantly looking for issues to manage and ways to get better. Leadership has to drive that change and a lot of folks struggle with this. QA managers should focus on training them to bring managers to embrace and communicate that culture.

FST: For companies first looking into certification services, what criteria should they be using while selecting a certification body?

Smith: The most basic requirement according to me is auditor availability. You need to identify a certification body that has more than one or two certified auditors. While price should be a consideration, it shouldn’t be the top priority.

As companies move to certification versus auditing, it is also important to look for a food safety partner, one who can service many of your foods safety needs such as testing, consulting, training etc., versus just auditing. For instance, can you call the Certified Body in case you have a recall or a food safety incident, and can the CB help you minimize the issue and solve the problem? Of course, customer service is an important consideration; the auditor and the team have to be responsive and polite.

FST: What steps can a company take prior to an audit to give themselves the best chance for success on the audit?

Smith: Training is critical. The facility and the personnel concerned with the audit process need to thoroughly understand the standard against which they are being audited, what will be asked and assessed for. Companies need to be harder on themselves than the auditor will be. Get others in maintenance and product involved in the facility and ask them questions that an auditor may ask. Train them to answer those questions.

Have strong internal auditing programs so you are prepared. You should know your issues and some auditor shouldn’t be telling you what the gaps are. All this is time and energy consuming, but it’s worth it.

Taking pictures both internal and external can also help, and can be a great training tool. When you have actual pictures from the facility and the processes, there can’t be too much room for debate.

FST: If the company disagrees with an auditor or the audit findings, what should they do?

Smith: The first thing I would say is don’t be afraid to ask the auditor questions. It is okay to say, ‘show me in the standard where it says this is a nonconformance.’ Remember to ask them before they leave. In most cases, asking such questions can help solve 75 percent of the issues.

Auditors can help describe why something is a nonconformance. If as a facility there’s still disagreement, you can go to the CB and provide a written description with as much information as you can, specific to the standard, about why you disagree with the audit. You can do an investigation and in many cases, probably 40 percent of the time, the auditor could have made an error, and gone beyond the standard. Remember that for the CB also, it’s important for them to get it right. So sites shouldn’t be worried about asking auditors questions, and CBs should respond to them – all in the process of continuous improvement.

Unfortunately, in some instances, it gets escalated beyond the CB to the standard owner. Though it’s a really drastic step, it has happened with SQF. As the final step, the site can still contact the Accreditation body, the American National Standards Institute.

FST: What are some other concerns regarding audits against the backdrop of FSMA proposed rules and GFSI?

Smith: As the industry is still waiting for final FSMA rules, one requirement that is causing some concern is auditors having to inform FDA when they see a nonconformance during a consultative audit. There is some concern that such a requirement would discourage people to try and get better. Industry is also waiting to see how FDA views certification audits. Can this be a process to ease imports, or, for domestic suppliers, be a risk-reduction tool? For instance, if there are two food facilities that make the same product, one that uses a GFSI scheme and one that doesn’t, can the one that uses be considered lower risk and not require as much resources to assess risk? Can inspections be done less frequently for such a facility? Will FDA accept such factors in the final requirements?

Ultimately, we need to remember that certification in the food industry in the U.S. is only about six years old. We all need to collectively continue to drive the process forward.

Robert Garfield, Senior Vice President of the Safe Quality Food Institute

SQF – The Road Ahead: Interview with Robert Garfield

By Michael Biros
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Robert Garfield, Senior Vice President of the Safe Quality Food Institute

Food Safety Tech: We’re very excited to have you kick off the SafetyChain/Food Safety Tech GFSI Leadership Webcast Series with your August 22 webinar, “SQF – The Road Ahead” webinar. Can you start by telling us what is new with SQF today? What are some of the things you’ll be talking about in terms of current changes?

Bob Garfield: We’re very busy here. We have a new version of our code, 7.2, which was introduced in the beginning of July. GFSI benchmarks standards every 3 years. Historically, SQF hasn’t waited for every 3 years to revise our code. This is the second time since our last benchmark that we will be revising our code based on the best science and technology that our stakeholders are putting forward. We’re pretty excited about that. We’ve added in some things that we think are important for all suppliers and people using the SQF code to keep them at the leading edge of science, technology, and the needs of buyers. That’s the primary one, but there are a bunch of things that I will be talking about as well in the webcast, including new modules on produce, feed, and pet food.

FST: We’re sure that unannounced SQF audits will be a topic of many questions during the webcast. What are some of the key takeaways attendees will leave the webinar with on this topic?

Garfield: Change is always difficult for some organizations. I understand why, but going through the SQF process is not to just get a certificate on the wall. We know from our stakeholders that it’s a commitment to food safety management, all the time, from the top to the bottom of a facility’s management. A facility needs to be audit-ready all the time, and we believe that the unannounced audit protocol that we are establishing will allow facilities to accomplish that audit readiness goal. We are fully aware that regulators and other food safety stakeholders are more and more looking at unannounced audits as the direction that food auditing needs to take in order to ensure consumers that what we are doing is the best it can be. It’s the most that we can do to ensure the safety of the food supply.

SQFI LogoFST: You will also be talking about the direction of SQF in 2015 and beyond? Is there a “theme” or specific set of business drivers that are driving future changes to SQF?

Garfield: Yes, there is. The business driver that is the primary focus of SQF is exactly what our executive committee from the Food Marketing Institute has told us – that the value proposition for SQF is to improve safety internationally as much as possible. Retailers are the closest that anyone can get to consumers. They believe that the purpose and the scope of SQF has to be continuous improvement to make food safety as close to foolproof as possible.

FST: What are some of the things we’ll learn in the webinar about why embracing change is critical to the ongoing success of SQF?

Garfield: Change is always critical and important. Embracing change is critical to the success of SQF because it is not a stagnant standard. It changes as science and technology evolve. Food safety and food safety management in particular are two areas that are constantly evolving as we learn more about how to protect the food supply chain, and we continuously update the code to make improvements that reflect this. Change is critical to the success of SQF. We are constantly evolving the code – it’s a process that must be ongoing.

FST: We know that you’ll be providing advice on how companies can start today to prepare for tomorrow’s SQF. Can you tell us some of the topics you’ll be addressing in this part of the webinar?

Garfield: To clarify, SQF doesn’t provide advice – we provide guidance with the SQF code. As we continue to evolve the code, we also evolve our guidance to support that process. I’ll be talking about things we do to help our users and stakeholders to evolve their own knowledge. For example, I’ll discuss our advanced practitioner course that we’ve just started to offer to help practitioners gain better understanding and know-how about how to manage food safety at their facilities.

FST: It has been said that SQF certification is a very good start to preparing for FSMA compliance. What are some of the key points you’ll be addressing when it comes to FSMA compliance?

Garfield: It is a good start. SQF is an international code and there are things in the code that are equal to or above what FSMA is requiring. There are also areas that are different. This is why we’ve hired Dr. David Acheson to do a comparison of our code against FSMA’s proposed preventive control and produce rules. Both of these comparisons are available on our website at www.sqfi.com. We’ll be able to make more comparisons/gap analysis when the final rules come out in 2015. As I discussed with FDA, we’ll look at the final rules and see how we match, exceed, or may need to do some work on our particular code if we think it’s appropriate.

Register for this complimentary webinar by clicking here.

Dr. Bob Strong

SQF Certification for Food Packaging Plants

By Dr. Bob Strong
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Dr. Bob Strong

The Global Food Safety Initiative is a set of standards created to assure confidence that food products meet international standards. GFSI sets the minimum requirements for Food Safety Management Systems, GMPs, GAPs, GDPs, and HACCP. All standards to get GFSI approval must meet the minimum requirements outlined in the GFSI guidance document. There are currently nine approved GFSI schemes, however only four apply to packaging.

Safe Quality Food or SQF, as it is more commonly referred to, originated as an Australian standard in 1994. It was purchased by The Food Marketing Institute in 2004 and is now operated by the Safe Quality Food Institute in the US. It was one of the first four GFSI approved schemes. It’s currently in edition 7.1 and is available from sqfi.com. Edition 7.2 will become effective July 3, 2014.

SQF offers three levels of certification: Level 1 is basically the fundamentals of food safety;  Level 2 requires at a minimum HACCP analysis and possibly a HACCP plan; and Level 3 requires a quality plan. GFSI approval only requires Level 2 SQF certification. 

SQF initial certification audits

The initial certification process requires two separate audits. The readiness audit reviews documents, programs, policies, and procedures to make sure that they match the SQF requirements. The auditor may look back through up to two years of records. SQF code also requires practicing continuous improvement and that the facility meets the regulatory requirements of the country in which the facilities operates as well as those of each country where product is sold. 

The second audit is a facility audit. This audit assesses how the facility is in compliance with the documented programs, policies, and procedures. The auditor will look at your equipment, building, processes, and records and will perform a graded evaluation. All deficiencies in this audit will need to be corrected before the Certifying Body can issue a SQF Certificate. For packaging plants, this audit usually takes two days but can take longer. Recertification only requires one annual audit that is a combination of the readiness audit and facility audit.

SQF practitioner

SQF certification requires that facilities employ a full-time SQF practitioner that is in a position to manage the program. This person must have completed an accredited HACCP course and be competent to implement and manage HACCP plans. They must also have SQF code knowledge and be competent to implement and manage SQF programs. While not required for certification, taking an SQF implementation course is highly recommended.

SQF for food packaging manufacturers

SQF has products and services divided into 35 food safety categories of which Category 27 is “Manufacture of Food Sector Packaging Materials.” The two modules of SQF code that require compliance from packing manufacturers are Module 2, SQF System Elements and Module 13, Pre-requisite Programs for the Manufacturing of Food Sector Packaging. The other modules do not relate to packaging and will not be part of the audit of a packaging facility.

The following are SQF mandatory sub-elements that are required to be documented and implemented by everybody. They cannot be excluded, exempted, or marked as non-applicable by the auditor. There are only mandatory elements in Module 2; there are no mandatory elements in Module 13.

  • 2.1.1 – Management Policy
  • 2.1.2 – Management Responsibility
  • 2.1.3 – Food Safety and Quality Management System
  • 2.1.4 – Management Review
  • 2.2.1 – Document Control
  • 2.2.2 – Records
  • 2.4.1 – Food Legislation
  • 2.4.2 – Food Safety Fundamentals
  • 2.4.3 – Food Safety Plan (levels 2, 3)
  • 2.4.4 – Food Quality Plan (level 3 only)
  • 2.4.8 – Product Release
  • 2.5.2 – Validation and Effectiveness
  • 2.5.4 – Verification and Monitoring
  • 2.5.5 – Corrective and Preventative Action
  • 2.5.7 – Internal Audit
  • 2.6.1 – Product Identification
  • 2.6.2 – Product Trace
  • 2.6.3 – Product Withdrawal and Recall
  • 2.7.1 – Food Defense
  • 2.9.2 – Training Program 

Nonconformities

A minor nonconformity must be corrected within 30 days of the facility audit. Extensions may be granted by the certification body where there is no immediate threat to product safety and quality, and alternative, temporary methods of control are initiated. 

A major nonconformity must be corrected and appropriate corrective action verified and closed out within 14 days of the facility audit. 

A critical nonconformity raised at a certification audit results in an automatic failure of the audit and the supplier must reapply for certification. 

Nonconformities can occur during the document audit or during the facility audit, but only the facility audit is scored. Out of a possible 100 points, a critical nonconformity will deduct 50 points, a major nonconformity will deduct 10 points, and a minor nonconformity will deduct 1 point each. All nonconformities should be corrected before an SQF Certificate will be issued, however if all minor nonconformities have not been corrected, a certificate can still be issued within 45 days of last day of facility audit. A score of 96 to 100 is ‘excellent’ (E), 86 to 95 is ‘good’ (G), 70 to 85 is ‘complies’ (C), and 0 to 69 is ‘fail’ (F). A certificate will be issued for grades of excellent, good, and complies. Excellent and good grades require a 12-month recertification audit and a grade of complies requires a six-month recertification audit.

The above article has been adapted from an archived webinar, hosted by SAI Global and presented by Dr. Bob Strong. For more details, please click here.