Marjan Smit International Supplier Auditing (ISA) Head office The International GMP Standard for corrugated and solid board: How it works Marjan Smit International Supplier Auditing (ISA) Head office

Content of the presentation Introduction of ISA Background of the Int. GMP code for corrugated and solid board Content of the International GMP code What about an GMP audit in practice? What are the effects of non conformities A glance in the future: what is the role that the International GMP code can have.

Introduction of ISA Set up in 1996 Dedicated to supplier auditing only 160 people; companies in Holland, UK, Belgium, Germany, Italy, France, Switzerland, Hong Kong, Israel, Austria, accredited to EN 45004 or 45011 Native speaking and licensed auditors in Spain, Portugal, and Turkey. Standards: BRC Food Standard, IFS, International GMP standard for corrugated and solid board, BRC/IOP packaging standard. Our customers: International retailers and producers of food and packaging.

Background of the International GMP code for the corrugated and solid board Increasing demands from customers on transparency in Hygiene. Amount of client audits are increasing; audits are performed by food people with different perspectives. The wish to be proactive. Existing initiatives in the sector like the Dutch GMP code, the Ondef code, the BRC/IOP code and MCAS code were not harmonized. The BRC did not want to cooperate with the sector to combine sector specific demands with the BRC/IOP demands.

“The International GMP standard for corrugated and solid board” Background… A truly International Team of corrugated and solid board representatives started the time consuming process of harmonisation, including test audits. The result: “The International GMP standard for corrugated and solid board”

Content of the int. GMP standard The standard is based on independent auditing by an EN 45011 accredited certification body. The auditee pays for the audit and becomes the owner of the audit report. Part 1 Standard with the demands Part 2 Audit protocol with instructions on how to audit against the standard Part 3 Glossary of terms.

Content of the Standard Chapter 1: Quality management Chapter 2: Factory standards Chapter 3: Contamination control Chapter 4: Personal hygiene

What about the audit in practice An audit on site will consist of four elements:   ·         Opening meeting ·         Documentation check on site ·         Site assessment ·         Closing meeting The audit on site has a very strong focus on the implementation of the demands in the standard. It is strongly based on the hazard inventory of the auditee.

What about the audit in practice During the test audit we found out: That an old factory with a good GMP policy can have a good result. It is not necessary to rebuild the factory as long as the auditee knows where the Hazards in his factory are and controls them. ISO certified companies had non conformities against the “quality management” demands of the GMP standard.

The auditor has 3 options to reward an element in the standard: A: In full compliance with the criteria in the standard B: Only partly in compliance with the criteria in the standard C: Not in compliance with the criteria in the standard.   The auditor has to motivate all B and C non-conformities in the audit report.

Minor non-conformity Every requirement in a standard that is awarded with a B or a C is seen as a minor non conformity if: The auditor does not give a major non conformity If the amount of C’s per chapter does not exceed the limit that is prescribed for this.  

Minor non-conformity In case the auditee only has minor non-conformities, a corrective action plan has to be delivered in 30 days after receiving the preliminary report. If the corrective action plan is sufficient the auditee will be recommended for certification. The corrective action plan will be part of the end report.

Major non-conformity A major non-conformity is:  “a substantial failure to meet a full clause of the standard and/or a failure that can directly lead to contamination of the product”.   It is the decision of the auditor to judge if a situation at the auditee can directly lead to contamination of the product.  There is also a limit on the amount of C’s per chapter. If the amount of C’s exceed the limit which is mentioned in this table, this will automatically turn into a major non-conformity.

Critical criteria (KO) In the standard there are 5 critical criteria pre defined. These 5 criteria have to be awarded with an A (in full compliance) or a B (only partly in compliance). When the auditor awards a critical criterion with a C, the auditee is automatically disqualified and cannot achieve certification.

Audit frequency Depending of the audit result: 6 or 12 month.

The audit report Audit summary with detailed description of the scope Summary and overview of non-conformities per chapter. Corrective action plan from the auditee with the actions on all non-conformities. Detailed listing of findings with motivation of critical, majors and B and C non-conformities.

A glance in the future The Food industry and the corrugated board producers are asked to actively give their input on the first version. Interested certification bodies who want to take the GMP code in their package are informed and invited. Implementation of the standard will in some cases demand a cultural change in the companies.

But with this code the corrugated and solid board sector shows that they take their customer demands seriously! A chance to be pro active towards clients

Thank you all for listening and good luck with the implementation Thank you all for listening and good luck with the implementation!! Marjan Smit International Supplier Auditing bv