Tag Archives: audits

FDA

FDA Releases Voluntary Retail Program Standards

By Food Safety Tech Staff
No Comments
FDA

After receiving input from federal, state, and local regulatory officials, along with industry and trade associations, academia, and consumers, FDA issued its Voluntary National Retail Food Regulatory Program Standards last week. The standards address “what constitutes a highly effective and responsive retail food regulatory program,” according to the document.

The Retail Program Standards include:

  • Promoting the adoption of science-based guidelines from the FDA Food Code
  • Promoting improvement of training programs to ensure local, state, tribal, and territorial staff have the necessary skills, knowledge and abilities
  • Implementing risk-based inspection programs
  • Developing outbreak and food defense surveillance plans to enable systematic detection and response to foodborne illness or food contamination

The 2015 edition contains new worksheets that are intended to assist regulatory programs in looking at how their programs line up with the 2013 Food Code. This includes helping them assess the consistency and effectiveness of their enforcement activities, and a verification tool to help independent auditors with these self-assessments. Although jurisdictions can use the worksheets and other materials without enrolling in the Retail Program Standards, FDA encourages them to do so, as enrollment allows them to apply for FDA funding. The agency also lists the jurisdictions enrolled in the program here.

FSMA Final Rules Almost Here, Guide to GFSI

By Food Safety Tech Staff
No Comments

With a host of mandatory requirements under FSMA means, businesses may want to consider GFSI certification.

The first FSMA deadlines are now two months away, and manufacturers may wonder how and where GFSI certification ties into increased regulation. First, what are some of the main differences between GFSI and FSMA? GFSI is seen as more global, while FSMA is more US-focused. Of course, the final FSMA rules will require mandatory compliance, and GFSI is voluntary. However, GFSI certification is recognized among major domestic and international retailers, so compliance with a GFSI-recognized scheme is an important part of a company’s food safety program.

The Food Safety Consortium Conference features a GFSI Services & Compliance track. With increased regulatory demands under FSMA, speakers will discuss the role of food safety certification systems. A GFSI-certified facility is one step closer to compliance with FSMA and may be held in higher regard by FDA from an auditing and inspection standpoint versus a business that has not opted to obtain certification.

Obtaining GFSI certification provides several benefits to the food industry, according to a recent TraceGains blog about the GFSI journey, including:

  • Reducing duplication of audits
  • Creating a comparable audit approach and outcomes
  • Enabling continuous improvement and customer opportunity for GFSI-benchmarked companies
  • Enhancing trade opportunities
  • Gaining cost efficiencies throughout the supply chain
  • Increasing competitiveness in the global market

Several food safety management schemes are recognized by GFSI. Among them is FSSC 22000, which touts the certification of more than 10,000 businesses worldwide. This year’s Food Safety Consortium also includes the first FSSC 22000 North American Harmonization Day on Tuesday, November 18. The meeting will provide a technical update of FSSC 22000, along with current scheme and future plans for expanding scopes and preparing for GFSI benchmarking.

How Supplier Scorecards Affect You

By Food Safety Tech Staff
No Comments

A supplier scorecard allows companies to measure vendor performance as it relates to risk management, quality, and compliance. Having up-to-date and accurate documentation, particularly surrounding foreign supplier verification, is an important part of FSMA compliance. Suppliers must be able to provide immediate and accurate information, especially in the event of an audit. Marc Simony, vice president of marketing at TraceGains, explains why companies should build the scorecard over time, evaluating a supplier’s performance against specific business requirements.

Ron Harrison, Ph.D., Director of Technical Services, Orkin, LLC
Bug Bytes

Make Employee Training a Team Effort in Your Pest Management Program

By Ron Harrison, Ph.D.
1 Comment
Ron Harrison, Ph.D., Director of Technical Services, Orkin, LLC

Pest management plays a key role in food safety and product integrity, and ensuring such is a critical, facility-wide undertaking. The success of a pest management program can be the difference between acing a third-party audit and facing a plant shutdown. An effective program is not just a one-person job; it requires an ongoing team effort from a company’s pest management provider and all employees. As such, beyond selecting an effective pest management provider, it’s equally important to recruit employees to help enhance your efforts. After all, they are the eyes and ears of your facility, as they spend a lot more time there than your pest management provider.

Arming your employees with the right tools and pest control knowledge will set up your pest management program for success. The following steps outline how you can get your entire team involved in your company’s program.

Teach the what, where and how

Your employees can be the first responders to any pest problems, but only if they know what they should be looking for and where they should be looking. For that reason, it’s essential that they complete training on the specific pest pressures your property faces and the red flags that alert them to pest activity.

Many pest control providers offer complimentary employee training, so ask your pest management professional to conduct an on-site training session for your team. These training sessions should include not only information about the specific pest pressures on your property, but also the conducive conditions and pest hot spots that your employees can help control. Pest hot spots are the key areas inside and outside your building that pests target as entry or harborage points. These areas are in constant danger of being penetrated by pests and are areas that currently or have previously had pest issues. Areas with standing water, excessive condensation or improper drainage are just a few examples.

Your pest management professional can also teach your employees the key components of integrated pest management (IPM). Rather than reacting to pest issues, IPM takes a proactive approach through a combination of non-chemical solutions, relying on chemical treatments only as a last resort. Proper sanitation practices, ongoing property maintenance to exclude pests, and regular monitoring are paramount to a pest-free facility.

Training sessions are also a great way for your employees and provider to build a strong relationship so your team is more likely to proactively report any pest issues.

Keep the lines of communication open

An open, ongoing line of communication between management, employees and your pest management provider is also an important component of successful pest management programs. Regular communication helps ensure that your employees are kept in the loop on important pest control information and initiatives. Furthermore, an open line of communication will keep you thinking proactively about pest management, which can help reduce decisions that lead to reactive chemical treatments.

This open dialogue will also help build rapport with your employees so they are more comfortable talking about sensitive issues, including the potential for bringing pests into the facility from home. 

Know your role

Your pest management program will work best when everyone involved knows his or her role. Consider assigning each team member a specific pest management task based on his or her daily duties. For instance, employees involved in facility maintenance can monitor for small holes or gaps in the building façade and seal them immediately to help prevent pest entry. 

 

In case of a pest sighting

Sometimes no matter how effective your IPM program is, resilient pests can still find their way inside your facility. Further, pest activity may not only originate locally, but from other parts of the country throughout the supply chain, making it somewhat difficult to immediately pinpoint the pest issue. This means there is a chance for both live and dead pests to make their way into your product, which can pose a nationwide health and safety threats to consumers.

With this in mind, it’s important to have a plan in place should a pest be spotted. Establish a pest sighting protocol that identifies the steps to report a pest incident, including who should be notified. The following are a few examples of steps that should be included in a pest sighting protocol:

  • If possible, catch and show the pest to your pest management professional.
  • Record the pest activity in a pest sighting report, making note of when, where and how many pests were seen.
  • Work with your pest management professional to determine what is causing the issue and how to resolve it.

Continue the education

Your employees need continued education to help keep your property on the cutting edge of pest control. Many pest management providers offer educational resources that facilities can use as ongoing education, including tip sheets, sanitation and maintenance checklists, and seasonal pest management tips. Ask your pest management provider if they have resources you can share with your team. You may also consider having your pest management professional provide further training sessions on specific pest problems.

Pest control is most successful when a team effort is involved. Work with your pest management provider to get your employees up to speed on the pest management efforts at your facility and ensure they have the basic knowledge needed to play a role in keeping pests out.

What Matters When Considering a Food Safety Audit?

No Comments

Food companies need to get audited and their personnel need to get trained frequently, and this is a growing trend in the evolving regulatory landscape and a highly competitive and global supply chain. However, what matters the most to food companies when getting audited? How significant is auditor competence as an attribute? How about the time that the audit takes, and the time to get the report? Or for training, what role does technology play?

To understand this, Eurofins conducted a blind survey of industry participants – nearly 600 respondents answered questions related to Certification and food safety Training.

Some of the highlights included:

EurofinsSurveyMarch2015_1EurofinsSurveyMarch2015_2EurofinsSurveyMarch2015_3 Ultimately, the following factors influenced food companies’ decision to go through food safety certification:

  1. Customer Requirements/Requests Relationships;
  2. Industry Standard; and
  3. Value Proposition. 

When it came to training, the top three influencers to go through Food Safety Training were identified as:

  • Developing Competence (Gaining, Improving, Growing)
  • Relevance and Subject of Training Cost and Time

EurofinsSurveyMarch2015_4

Top 5 Reasons Organizations Fail Audits and How to Not Be One of Them

By Chelsey Davis
No Comments

When it comes to audits, there are plenty of reasons for failing, especially in the food and beverage industry. To help shed light on some of the reasons companies fail audits and to help prevent future failure, here’s our top 5 reasons to why organizations fail.

When it comes to audits, there are plenty of reasons for failing, especially in the food and beverage industry. Whether it’s an audit for GFSI, FDA or an audit required by any of your customers, the consequences of failing can be very costly. And while the whole team receives praise when an audit is successfully completed, there are a select few that bear the burden of audit failure (QA professionals). To help shed light on some of the reasons companies fail audits and to help prevent future failure, we’ve listed our top 5 reasons to why organizations fail.

1. Human Error

It doesn’t matter what industry you’re in, human error is bound to occur. The key here is to be able to minimize the chances of human error as much as possible. As a quality assurance manager, it’s important to make sure all employees are well-trained and fully understand the reasoning for performing certain functions of the job in a particular way. When employees understand the why regarding processes, it will be easier to remember going forward. Additionally, you should have systems and internal audits in place to ensure that what is supposed to happen is happening.

2. Compliance vs. Business as Usual

During audit time, there is often a conflict of interest when it comes to quality assurance managers and making sure the business is still operating as usual. As part of the process to prepping for an audit, management needs to ensure everything is up to standards, and this can possibly include stopping production lines, which interferes with the operation manger’s strict schedules. The important thing to convey here is the fact that compliance should come before anything else. The consequences of failing to meet compliance requirements will surely cost more than a delay in product delivery.

3. HACCP Failure

Hazard Analysis and Critical Control Points (HACCP) is a management system that helps prevent foodborne diseases and essentially operates to protect consumer safety. When it comes to audits, HACCP documentation is incredibly important, which is why it’s crucial to have it complete and comprehensive. Not doing so can be enough to cause your organization to fail. (Download this HACCP checklist as a guide to help you get started).

4. Lack of Supplier Control

All the guidelines and processes in the world you use to keep your organization compliant wouldn’t help much if your suppliers weren’t in sync. And with today’s global food supply chain, it is becoming increasingly difficult to manage risks of food fraud and contamination. One way to help tackle this issue is supplier scorecarding. Automated scorecarding helps both parties examine data and results based on the same information, fostering closer collaboration, information exchange, review of standard and best practices, as well as the occasional review of ingredient specifications, so that all stakeholders involved can work toward the same goals.

5. Lack of Documentation and Organization

“The best part about prepping for an audit is gathering all the required documents,” said no one ever. Not being organized can definitely hinder your chances of successfully completing an audit. And with multiple suppliers providing multiple different documents, staying organized can be a challenge. A filing cabinet just won’t cut it anymore. As a quality assurance manager, you were not hired to be a paper clerk, but agile document management is critical to the success of your business. This is where automation comes into the picture. Are you getting the data and information out of your documents that you need to improve your business? Can you satisfy an auditor with just a few mouse clicks? Automating this process not only helps your organization overall, but also helps you—the quality assurance hero—save time and energy.

Check out our chat with John Paul Williams, Director, Enterprise Solutions and Market Development, Americas, at Polycom, to learn more about why automation is so important for evolving businesses.

What’s Frustrating for Food Manufacturers?

By Food Safety Tech Staff
No Comments

Gary Nowacki, CEO of TraceGains, highlights the concerns that came out of an Ask the Expert discussion about Supplier Qualifications and Management at the 2014 Food Safety Consortium.

“A common takeaway–whether it was small, mid-size or large companies–was the frustration of having to do more audits, and the growing demand for more paperwork. A question that was often asked was that ‘my customer is asking me to subscribe to a different audit, and that defeats the promise of GFSI, that it would lead to fewer audits.’ My advice to them is to not just blindly agree, but ask the customer politely what exactly they are looking for, and see if they can address that. Another frustration related to the increase in paperwork and the time and resources consumed in filling these plethora of forms. So there was a discussion about how we can standardize these. And people are looking to get automated solutions as they are not getting more headcount.”

How to Run an Audit-Ready Co-Pack Operation

By James Houghton
No Comments

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
No Comments
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
No Comments

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.