WEB SITE ANNOUNCEMENT
- BEST ISO considers the FDA FSMA revisions to be significant in nature, primarily due to changes in structure, along with introduction of some additional concepts and themes. It is our goal to ensure that we perform value added audits that establish an organization’s level of conformity to these standards and in doing so help our clients understand both the intent and the philosophy behind the changes.
- This policy relates to BEST ISO’s certification services covered under its accreditation.
- BEST ISO’s will announce the following change in the web site and email to all clients
- Business or Shareholder change
- IPO
- Change the Head quarter or branch contacted address
- Any change for the program and SCOPE
- The change of Head or chairman of the company ,ICB or committee
- The new branch open
- The certification issuing
- The certification withdraw and suspending
- The big change for the certification process
2 General web announcement
2.1 All current existing certificates will announce the following information
2.2 A new certificate to the new version will be issued when it can be satisfactorily shown that a client has fully met the requirements of this new standard. As is the current practice, all major non-conformities must be formally closed out and corrective actions for any minor non-conformances must be received and accepted by BEST ISO, prior to issuance of a certificate.
2.3 Prior to the Transition Audit from the previous FDA FSMA pilot certification being undertaken, clients are required to complete ST2 audit and re issue the new FDA FSMA certification.
3. IA SV and RA man day
4. Sampling for the testing products
5. REPORT to USA FDA
Best ISO or its audit agent, where applicable will notify FDA immediately in this web site if, at any time during a food safety audit, discovers a condition that could cause or contribute to a serious risk to the public health and provide information required by IAS and FDA.
5. Auditing Finding
As a result of an observation(OFI) or finding( MAJOR or minor) during a regulatory audit, an eligible entity must implement a corrective action plan to address a deficiency and evidence in (MAJOR need From 8-NC management minor could use the form 35-section 4 auditing finding) to Best ISO, Best ISO may not issue a food or facility certification to such entity until after the Best ISO verifies that eligible entity has implemented the corrective action plan through methods that reliably verify the corrective action was taken and as a result the identified deficiency is unlikely to recur, except onsite verification is required for corrective actions required to address deficiencies that are the subject of a notification (see clause 4.15).
If happen the on site closed the NC that same as 4.10.3
5.1 Major: One or more of the following:
5.2 Minor: A failure to comply with the safety requirements of the FD&C Act and FDA regulations that, based on judgment and experience is not likely to result in the failure of the quality management system or reduce its ability to ensure controlled processes or products usability.
2.3 Prior to the Transition Audit from the previous FDA FSMA pilot certification being undertaken, clients are required to complete ST2 audit and re issue the new FDA FSMA certification.
3. IA SV and RA man day
- The initial audit (IA) man day that address in the documents AR-2-5 and man day table (form 32) that only for ST2 and exclude the ST1.
- The Surveillance audit (SV) same man days for the second year is the same man days as the ST2,
- However if add the scope or the change such as the address or employees that need new contract review and to be the ST2 manday audit.
- The Re-certification is the same as the ST2 man day.
- Follow the Antalya CAPA audit that when the client will plan manufacture the products that shipping to USA need to inform the BEST ISO before one week that BEST ISO could arrange any no announce audit.
- Best ISO will not use an audit agent to conduct a regulatory audit at an eligible entity if such audit agent conducted a consultative audit or regulatory audit for the same eligible entity in the preceding 24 months, except that such limitation may be waived if the accredited third-party certification body demonstrates to FDA. Best ISO will ask the all agent to sign the 4.7.1 agreement and will sue the agent if they cheat the Clients, FDA, IAS and BEST ISO.
4. Sampling for the testing products
- All shipping USA products need have the FQC report for each manufacture order.
- Sample the products in the marketing in the manufacturing site when the onsite auditing and the storage area. The storage need FIFO policy to sample.
- The above three samples need to send to the qualified laboratory to do the IAS FDA testing.
- If the product is cooling or frozen products that must send from the clients site with the special shipping company that still need to careful to avoid the clients to effect the final test result.
5. REPORT to USA FDA
Best ISO or its audit agent, where applicable will notify FDA immediately in this web site if, at any time during a food safety audit, discovers a condition that could cause or contribute to a serious risk to the public health and provide information required by IAS and FDA.
5. Auditing Finding
As a result of an observation(OFI) or finding( MAJOR or minor) during a regulatory audit, an eligible entity must implement a corrective action plan to address a deficiency and evidence in (MAJOR need From 8-NC management minor could use the form 35-section 4 auditing finding) to Best ISO, Best ISO may not issue a food or facility certification to such entity until after the Best ISO verifies that eligible entity has implemented the corrective action plan through methods that reliably verify the corrective action was taken and as a result the identified deficiency is unlikely to recur, except onsite verification is required for corrective actions required to address deficiencies that are the subject of a notification (see clause 4.15).
If happen the on site closed the NC that same as 4.10.3
5.1 Major: One or more of the following:
- The absence of or total breakdown of a system to meet an FDA FSMA requirement and the safety requirements of the FD&C Act and FDA regulations.
- Any finding that would result in the probable shipment of nonconforming products.
5.2 Minor: A failure to comply with the safety requirements of the FD&C Act and FDA regulations that, based on judgment and experience is not likely to result in the failure of the quality management system or reduce its ability to ensure controlled processes or products usability.