Tag Archives: audits

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.