general regulation part ii ( group certification)€¦ · roles!in!the!qms! internal!auditor!!! •...

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GENERAL REGULATION PART II ( Group Certification)

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Page 1: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

!!

GENERAL REGULATION PART II ( Group

Certification) !

Page 2: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Legality

•  Documents clearly demonstrating ownership

•  The legal right to carry out agricultural production and/or trading

•  Signed Sublicense and certification agreement with a CB

•  One QMS per country (one product)

Page 3: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Producers and production sites

•  Requirements for Producer groups •  Written contract consists of

–  Producer group name and legal identification –  Name and address of the producer –  Details of production locations/PMUs –  Producer�s commitment to comply with GLOBALGAP

requirements, group�s procedures and sanctions in case above requirements not being met

–  Signature – producer and group representative

•  Producer individually can not sell produce as certified.

Page 4: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Producers and production sites

•  Requirements for Multisites •  All PMUs shall be owned or rented •  If rented – written contract between PMU owner and the

legal entity consisting –  Name of certificate holder and legal identification –  Name and address of site owner –  Details of PMUs –  Indication reflecting rights of legal entity in

production operations –  Signature – both parties

Page 5: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Producer!member/!produc-on!site!registry!!

•  Name!of!producer!!•  Name!of!contact!person!•  Full!address!!•  Contact!data!•  Other!legal!en6ty!ID!•  Products!registered!•  Details!of!the!individual!produc6on!

sites!(if!MS)!•  Growing!area!and/or!quan6ty!•  Cer6fica6on!body(ies)!!•  Date!of!last!internal!inspec6on!

! ! ! ! ! ! ! !! ! ! ! ! ! ! !!

Use!the!indent!buHons!on!the!Home!tab!to!change!the!level!of!text.!

•  Name!of!produc6on!site!•  Contact!details:!address!•  Contact!data:!Phone/fax!number,!

email!•  Northern/Southern!la6tude!and!

Eastern/Western!longitude!is#voluntary.!!

•  Products!produced!in!each!produc6on!site!!

•  Growing!area!and/or!quan6ty!•  Site!legal!status!(owned,!rented)!•  Produc6on!!site!GG!status!!!!

Op6on!2!–!members! Mul6sites!with!QMS!S!units!

Page 6: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Producer and Site Internal Register

•  All producers applied for certification must be registered on the database

•  Producers who do not apply for certification must be listed separately

Page 7: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Organization Structure

•  Be able to manage the QMS in line with GLOBALGAP requirements

•  Shall be documented and include individuals responsible for –  Managing the implementation of GLOBALGAP –  Managing the QMS –  Carrying out internal inspections –  Carrying out internal audit on QMS –  Technical advice to the group

Page 8: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Roles!in!the!QMS!!Internal!auditor!!

•  Inspec6on!of!QMS!•  Approval!of!farms/sites!•  If!acts!as!II!as!well!–!can!not!approve!his!work!!•  Can!not!responsible!for!daily!QMS!management!Internal!inspector!!•  Inspec6on!of!farms/sites!If!there!are!more!of!them:!Training!&!Evalua6on,!witness!audit!•  !Has!sufficient!authority!to!independent!and!technically!jus6fiable!decisions!during!

internal!control?!•  Do,!in!all!cases,!internal!inspectors!have!prac6cal!knowledge!about!the!products!they!

are!inspec6ng?!•  Do!auditors!and!inspectors!strictly!observe!the!producer!group’s/company’s!procedures!

to!maintain!the!confiden6ality!of!informa6on!and!records?!•  Technical!advisors/subcontractors!–!meet!the!requirement!of!CPCC ! ! ! !

! ! !!

Use!the!indent!buHons!on!the!Home!tab!to!change!the!level!of!text.!

Page 9: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Competency and Training of Staff

•  Competency requirements shall be documented as per –  Annex II.1 – internal auditor and inspector

•  Records of qualification including completed online exams and training shall be maintained.

•  Shadow audits/inspections (if more than one inspector/auditor)

•  Key staff shall be informed with developments, updates etc.

Page 10: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Roles!in!the!QMS!!Internal!auditor!!

•  Scope!related!postShigh!school!diploma!OR!

•  AgriShigh!school+2!yrs!prac6ce!OR!•  Any!high!school+!2yrs!QM+!3!yrs!overall!

prac6ce!

•  Prac6cal!knowledge!on!MS!•  QMS!internal!auditor!training!!16hs!•  HACCP!training!•  Food!Hygiene!training!•  Plant!Protec6on,!fer6lizer,!IPM!training!!

Use!the!indent!buHons!on!the!Home!tab!to!change!the!level!of!text.! Internal!inspector!

•  Scope!related!postShigh!school!diploma!OR!

•  AgriShigh!school+2!yrs!prac6ce!OR!•  Any!high!school+!3!yrs!prac6ce!•  1!day!prac6cal!inspec6on!course!•  2!inspec6on!observa6on!(CB/qual)!•  1!successful!shadow!by!IA!•  HACCP!training!•  Food!Hygiene!training!•  Plant!Protec6on,!fer6lizer,!IPM!!

Page 11: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Document Control

•  QMS documentation shall include

–  The quality manual – content shall be reviewed periodically

–  GLOBALGAP operating procedures – shall be available to relevant staff

–  Work instructions –  Recording forms –  Relevant external standards

Page 12: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Document Control

•  Document control requirements –  Written procedure – control of documents –  Identification of documents –  Review and approved by authorized personnel –  Availability –  Control of obsolete documents

•  Records –  Demonstrate effective control of QMS –  Shall be kept for min. 2 years –  Shall be genuine, legible, stored and maintained

Page 13: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Complaint Handling

•  A documented procedure describing how complaints are received, registered, identified, investigated, followed up and reviewed.

•  Procedure shall be available to customers •  Procedure shall cover both complaints to the group and

individual producers.

Page 14: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Internal QMS Audit

•  Audited annually

•  Auditor with qualifications as set in Annex ii A

•  Auditor shall be independent of the area being audited

•  Records of internal audit shall be maintained –  Completed QMS checklist with comments –  Follow up of corrective actions

Page 15: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Internal producer/PMU Inspections

•  Each producer/PMU shall be inspected annually •  Inspector with qualifications as set in annex II.1 •  Inspector shall be independent •  New members shall always be inspected prior to

external inspection •  Inspection reports shall be available •  Internal auditor�s/management representative�s review

of inspection report

Page 16: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Non-compliances, Corrective action and Sanction

•  Documented procedure for identification and evaluation of non-compliances

•  Corrective actions – evaluated

•  Implementing corrective actions

•  System of sanctions including –  Notifying the CB –  Records of sanctions

Page 17: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Product Traceability and Segregation

•  Products!shall!be!traceable!and!prevent!mixing!with!nonScer6fied!products!•  Documented!procedure!–!iden6fica6on,!traceability,!mass!balance!•  In!case!of!parallel!produc6on!–!�traceability!and!segrega6on!(AF.12)��applies!•  Incoming!and!outgoing!product!flow!procedure!–!records!•  Conversion!ra6ons!are!calculated!for!each!handling!process!and!all!waste!is!

calucated!•  GLOBALG.A.P.!cer6fied!product!entering!the!process!shall!be!immediately!

iden6fied!S!either!with!GGN!or!any!reference!(wriHen!policy)!•  Obliga6on!for!Mul6sites/PGs!with!PP/PO!!S!labelling!the!product!with!GGN!

! !!

Page 18: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Withdrawal of Products

•  Documented withdrawal procedure

–  Identifying types of events that may result in a withdrawal

–  Can be operated at any time –  Shall be tested at least annually

Page 19: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Subcontractors

•  Subcontractor shall be assessed. •  Records demonstrating competency of subcontractor

(assessed)

•  Agreement or contract with the subcontractor�s commitment work in accordance with QMS

Page 20: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Registration of Additional Producers/PMUs

•  Inform the CB on any additions/withdrawals

•  Up to 10% of new producers can be added in one year

•  If exceed 10% - external inspection

•  Addition of 10% of new producers should not exceed increment in production area by 10%.

Page 21: GENERAL REGULATION PART II ( Group Certification)€¦ · Roles!in!the!QMS! Internal!auditor!!! • Scope!related!postShigh!school!diploma! OR! • AgriShigh!school+2!yrs!prac6ce!OR!

Thank You

© GLOBALG.A.P Secretariat | Page 21