Tag Archives: audits

How to Run an Audit-Ready Co-Pack Operation

By James Houghton
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If an auditor were to walk through your site today, would you be proud of its set-up and its ability to uphold quality and regulatory standards for yourself and your client?

I think many of us have once been – or are still – in a state of scurrying around right before an auditor knocks on our front doors. When you’re small and growing quickly, it’s hard not to be reactive for things like regulatory audits. But at some point, you have to proactively build out repeatable processes to drive long-term growth, and start really taking control of your own operation.

Here’s the ideal:

You want your co-pack operation to be in a state of audit-readiness. That is, if an auditor were to walk through your site today, you’d be proud of its set-up and its ability to uphold quality and regulatory standards for yourself and your client.

Earlier in October, I presented a webinar on “How to Run an Audit-Ready Co-Pack Operation,” i.e., how to get your house in order. Here are the five pillars of maintaining a state of audit-readiness for your co-pack operation:

Culture

In the same way that you have built a culture of collaboration and client satisfaction you’ll also need to build one for Quality. The way you prioritize and permeate Quality initiatives throughout the organization, from your senior team to your shop floor staff, will show when the auditor walks through the doors.

Paperwork

It’s vitally important that your paperwork is in order, including your SOPs, transactional items like RFQs, POs, and SOWs, and most importantly, the batch record. The auditor will be looking for two things amongst all of your documentation: content and consistency. The content needs to meet regulatory requirements, and there needs to be consistency between what you say you do and what you actually do.

It’s not rocket science: you need to write out what you do, and then you have to do the activities that reflect what you’ve written down. This is often the one thing that won’t be maintained properly, unless it’s given attention.

Physical Space

Your physical space will be audited to ensure it’s set up with the correct flow, that it is kept clean, and there is documentation to that effect.

To make sure your physical space is up to par for an audit, imagine that you yourself are the product… go back to your receiving doors and physically walk through your facility, as a “day in the life” of your product. You’ll be able to see where you go, how you are handled, and where each step is documented. Along the way, anything that’s not delineated, not treated or identified properly, or does not follow a logical flow, are the areas you need to lock down before an audit.

Material Control

An auditor will want to see that you’re in control of your materials, and that you have track and traceability. Being able to track where you’re storing things in the site, where it’s moving, what your processes are for moving inventory, etc… all that demonstrates that you have the traceability controls to be able to handle mock and real recalls and maintain consumer safety.

Production

Ahh… the production line. It’s where the magic happens. When setting up your production line, you need to make sure you have appropriate line clearance, the lines are segregated, the correct staff are on the line to do the project, and that they have had the proper training for their particular activity in the line. In the co-pack world, where things are highly customized with low repeatability, it can be easy to overlook the extensive amount of training it takes to make sure each production line is in good hands. You need, however, to make sure you do your due diligence to maintain production accuracy, quality assurance, and regulatory standards.

In the webinar, I discuss each of these areas in greater detail. If maintaining a state of audit-readiness is an endeavor you’d like to pursue, watch the webinar for more details or access the slide deck by clicking here

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.

Ask the Compliance Expert: Unannounced Audits

By Sangita Viswanathan
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Do you know when your next unannounced audit will be? And can a site refuse entry to an auditor? In this Q&A, Jane Pappin of Cert-ID provides some answers.

Food companies are now handling and preparing for increased number of inspections and audits. Food safety rules under the Food Safety Modernization Act have proposed unannounced audits of food facilities as a way to include another level of security to ensure that these facilities are compliant with the various standards. Such audits, regulators hope, will give a more realistic picture of compliance, rather than facilities appearing to comply just the day of the inspection.

Food companies that have been abiding by all the requirements of the specific food safety standard don’t have to do anything differently than what they have been doing all along, says Jane Pappin, Certification Director at Cert-ID: “If they have a strong food safety and quality management program in place, have been conducting regular internal audits, and gap analysis etc., they shouldn’t have anything to worry about. The auditor is not going ask anything that they would be unprepared for,” she adds.

We present below excerpts from a Q&A with Pappin.

Q: How will my site know if our next audit is unannounced or not?

A: SQF has indicated that the Certification Body (CB) is responsible for telling the site when their unannounced audit will be. As the CB is charged with reminding the site of their upcoming renewal audit approximately three to five months in advance of the re-audit due date, the site could be informed then.

Once the site is told when their unannounced audit will be, there is opportunity to negotiate black-out dates – these are only for days when the site will not be in production. The unannounced audit will always take place within the site’s renewal audit window, which is from 30 days before the site’s re-audit due date (which is listed on your certificate) to 30 days after the re-audit due date. 

A site must have one unannounced audit per three-year cycle. For those sites already certified, their first unannounced audit will take place either in 2014 (from July 3 to Dec 31), 2015 or 2016 and they will be informed by their CB which year it will be in. Their second unannounced audit will take place in either 2017, 2018 or 2019, and so on. Once your unannounced audit year is determined, this will be recorded in SQF’s Reliance Database. Even if you change CBs, this information will go with your facility’s profile and your unannounced audit year will not change.

Q: What happens if the auditor arrives for the unannounced audit and the site refuses entry?

A: The ramifications of disallowing the auditor entry to your facility are far reaching: First, you will still be charged for the visit, including auditor expenses. Second, your facility will immediately be put into suspension. Third, an announced audit must now take place no later than 30 days from the date you denied entry to the auditor. If this doesn’t happen, your certification will be withdrawn. Fourth, because you were put into suspension, you will also be required to have a surveillance audit six months after the 30 day audit. Fifth and last, your next audit will then be your unannounced audit.

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