Seed Program Quality System Procedure QSP 142.3
Authorized Seed Crop Inspection Service Monitoring and Auditing

Appendix I - Objectives of the Quality System Review Audits

The objective of the Quality System review in a complete systems audit or a partial systems audit is to ensure that:

  • management has approved the company pedigreed seed crop inspection service control system and accepted responsibility for the process;
  • the pedigreed seed crop inspection service control system is documented, current, and adhered to by its employees;
  • the pedigreed seed crop inspection service control system has a documented procedure to keep its system current;
  • the pedigreed seed crop inspection service control system stipulates that the parental material; provided will meet the minimum requirements under CSGA's Circular 6 (and its amendments) and the Seeds Act and Regulations;
  • the pedigreed seed crop inspection service only uses licensed seed crop inspectors;
  • the licensed seed crop inspector is following the appropriate SWI for the crop kind;
  • where appropriate, the pedigreed seed crop inspection service control system includes a mechanism to react to and dispose of seed that does not meet the pedigreed seed requirements;
  • the pedigreed seed crop inspection service has a system to analyse the cause of a non-conformity and take corrective action;
  • the pedigreed seed crop inspection service trains staff who are responsible for pedigreed seed crop inspection on its Quality manual and ensures that its seed crop inspectors are evaluated and licensed.

The lead auditor will use the documents in Appendices VII-VIII to review the submitted quality manual. In addition to the checklist, the following questions will assist in assessing the applicant's quality program documentation.

Completeness: Are all activities described? Are all CFIA requirements comprehensively covered, as specified in the system checklist?

Language: Is the documentation written in language that can be easily understood by the people who have to read it, follow it or implement it? (Is it simple and practical?)

Clarity: Is it free of all ambiguity and conflicting statements?

Responsibilities: Does it clearly specify who is responsible for what?

References: Are required documents and records identified and their use explained?

Forms: Are sample forms included and referenced in the descriptions?

Review: Are there arrangements to ensure that the program documentation is reviewed with the proper frequency by the appropriate people?

Updating: Is there a mechanism for ensuring the documentation is kept current, up-to-date and properly supported?

Changes: Is there provision to ensure that all changes receive the same care and authorization as the original?

Obsolete Documents: Is there provision for removal of obsolete documents?

Appendix II - General Verification of Submitted Documentation Checklist

Documents Verified Conformity
AD*		 Conformity
UN*		 Conformity
NA
1. Compare the information on the report submitted by the licensed seed crop inspector with the report submitted by the official crop inspector      
2. All required documentation is present:
  • information on parental material (crop certificate number)
  • field on which parental material was planted (map, application)
  • Report of Seed Crop Inspection
      
3. Report was complete and accurate      
4. Report was made by licensed seed crop inspector as indicated by a signature and inspector number      
5. Licensed seed crop inspector was authorized for the crop kind/species      

AD* Adequate
UN* Unacceptable (information is not adequate or the item has not been addressed)
NA Not applicable

Appendix III - Classification of Non-Conformances - Authorized Seed Crop Inspection Service

CRITICAL
The inspected pedigreed seed crop or a portion thereof cannot receive certification due to a lack of &/or inaccurate information. Inspector's licence is suspended and the auditing inspector's reports are submitted to CSGA for certification assessment.

CARS are addressed to the following person: Crop Inspector Manager
Inability to accurately identify the crop X  
Inspection of the incorrect crop X  
Provision of anticipated CSGA decision on a Report of Seed Crop Inspection X X
Failure to complete Reports of Seed Crop Inspection X X
Inspection carried out by non-accredited personnel
  • crop inspector not licensed for crop kind or pedigreed status level
 X X
  • personnel other than licensed crop inspector not under the direct supervision of a licensed crop inspector
   X
Three or more major non-conformances detected at one audit X X
Any one major non-conformance at three consecutive audits X X
Provision of false or misleading information to the auditor X X
Maintenance of any false or misleading records in respect of any pedigreed seed or crop X X
Provision of any false or misleading information on a Report of Seed Crop Inspection X X
Failure to report potential discrepancies in variety descriptions to certification bodies where required   X

 

MAJOR
The inspected pedigreed seed crop or a portion thereof cannot receive certification due to a lack of &/or inaccurate information. Inspector's license may be suspended and the auditing inspector's reports are submitted to CSGA for certification assessment.

CARS are addressed to the following person: Crop Inspector Manager
Failure to report localized weeds or off-types X  
Taking counts in a non-representative manner (clustering) X  
Provision of inaccurate land location on Report of Seed Crop Inspection X  
Some detailed inspection visits were not conducted during the pollination period or at the appropriate stage for inspection (i.e. too early or too late) but the crop stage was not noted on the report X  
Failure to accurately report isolation problems (i.e. distances from seed field, severity of contaminating source, effectiveness & number of border rows) X X
Failure to report detasselling problems that exceed the CSGA standards X X
Failure to use correct count area for plants as specified in QSP 142.1 X  
Failure to perform the required number of counts X  
Failure to obtain variety description or failure to report absence of variety description on Report of Seed Crop Inspection X X
Failure to report altered count area X X
Failure to report off-type plants in either male or female that exceed the CSGA standards X X
Failure to report weeds or other crop kinds of significance to the inspected crop at stage when they are identifiable X X
Failure to report volunteer corn plants that exceed the CSGA standards and are shedding pollen during the pollination period X X
Failure to report variants in excess of tolerances provided on the official description of variety X X
Failure to conduct inspections at appropriate growth stages X X
Failure to report planting problems (i.e. mix-up of male and female seed) X X
Failure to report potential contamination from adjacent seed crops with detasselling/plant removal problems X X
Failure to deliver inspection reports to CSGA in a timely manner X X
Failure to provide auditor with inspection records/reports in a timely manner X X
Mandatory documents are missing
  • information on parental material
 X X
  • field on which parental material was planted
 X X
Improper decision
  • classifying seed that does not meet Circular 6 requirements as pedigreed on documents other than the Report of Seed Crop Inspection
 X X
Three or more minor non-conformances detected at one audit X X
Any one minor non-conformance at three consecutive audits X X

 

MINOR
Certification of the seed crop is not immediately at risk. Corrective actions are required to retain confidence that the licensed inspector follows Quality System Procedures.

CARS are addressed to the following person: Crop Inspector Manager
Failure to check previous land use X  
Failure to identify a reportable disease X  
Misidentification of obvious environmental factors causing plant deviations X  
Inaccurate reporting of weed pressure X  
Providing unclear description of off-type plants X  
Failure to report problem areas e.g. lodging, flooding X  
Completing reports in an illegible manner X  
Failure to complete and attach crop inspection rough notes to final report (checklists) X X
Failure to provide the estimated pollination dates for inspected seed crops, where applicable X X
Failure to submit application and field maps as per CSGA deadlines where under control of authorized crop inspection service   X
Report forms were not signed by the inspector X X
Portions of the final report were not completed (e.g. volunteer corn acreage, date inspected, variety and acreage inspected) X X
Minor map corrections were not made (e.g. identifying those crop kinds around seed field that are not contamination problems) X X
Some detailed inspection visits conducted during pollination period were not reported on the final report X  

Appendix IV Calculation of Audit Frequency

Having categorised the non-conformances using Appendix III and QSP 142.4 Appendix IV where applicable, use the following to calculate the audit frequency.

(1) List current audit frequency status:

(2) List numbers of non-conformances based on classification,

  • Critical:
  • Major:
  • Minor:

(3) Using the notes below, calculate the final number and classification of non-conformances:

  1. If the same minor non-conformance has been identified at the previous two audits, reclassify as major
  2. Every three minor non-conformances are reclassified as one major non-conformance
  3. If the same major non-conformance has been at the previous two audits, reclassify as critical
  4. Every three major non-conformances are reclassified as one critical non-conformance.

(4) List recalculated numbers of non-conformances based on this consideration:

  • Critical:
  • Major:
  • Minor:

If any critical non-conformances are identified, the audit frequency is automatically changed to tightened with the tightened audit frequency reflecting the total number of non-conformances identified. Go to (f)

If no critical non-conformances are identified:

(a) How many major non-conformances?

None go to (b)
one or more go to (f)

(b) How many minor non-conformances?
What audit frequency is authorized crop inspection body currently on?

No. Minor Non-conformances Current inspection frequency Next Step
None reduced go to (g)
None normal go to (c)
None tightened go to (c)
One or two reduced go to (c)
One or two normal go to (c)
One or two tightened go to (e)

(c) If on tightened frequency

two clear audits go to (d)
less than two clear audits go to (e)

If on normal frequency

three clear audits go to (g)
one or two audits with minor non-conformances, go to (d)
three audits with one or two minor non-conformances, go to (e)

If on reduced frequency

two clear audits go to (g)
less that two clear audits go to (d)

(d) Audit at normal frequency

(e) Audit at tightened frequency

(f) Determine whether the specific non-conformances require suspension of the authorization of the crop inspection service or licence of crop inspector. If so, implement suspension. Upon reinstatement, the initial audit frequency is automatically at the tightened level

If the non-conformances do not require suspension, the audit frequency must be increased one level ie. If at a reduced audit frequency, this would be changed to a normal frequency and if at a normal frequency, this would be changed to tightened frequency.

(g) Audit at reduced frequency.

(h) List revised audit frequency status:

Appendix V - Authorized Seed Crop Inspection Service Quality System Review Status Report

(To be completed by CFIA)

Audit Review Status Code Issue/ Revision/ Date of Manual Date of Audit Lead Auditor Recommended for Provisional Status By Letter Date
           
           
           
           
           
           

The number of the system review is to be placed in the Status Code column.

1 CSR First Complete Systems Audit
2 CSR Second Complete Systems Audit
3 CSR Third Complete Systems Audit
SA System Acceptable
1 PSR First Partial Systems Audit
PSA Partial System Acceptable

Letter Date - Date of letter or report sent to applicant with respect to audit results from a complete systems audit or a systems and surveillance audit to determine the implementation of CARs.

Appendix VI - Authorized Seed Crop Inspection Service System Review Summary Record

CLAUSE QUALITY SYSTEM REQUIREMENTS COMMENTS/ CARs CONFORMITY
AD		 CONFORMITY
UN
CR		 CONFORMITY
UN
OT		 CONFORMITY
NA
1 Management responsibilities (inter-relation chart)    
 		      
2 Quality system    
 		     X
3 Contract review - NA    
 		     X
4 Design Control - NA    
 		      
5 Documentation    
 		      
6 Purchasing Control    
 		      
7 Customer Supplied Product    
 		      
8 Product Identification and Traceability    
 		      
9 Process Control    
 		      
10 Inspection and Testing    
 		      
11 Inspection, Measuring and Test Equipment    
 		      
12 Inspection and Test Status    
 		      
13 Control of Nonconforming Product    
 		      
14 Corrective and Preventative Action    
 		      
15 Handling and Storage    
 		      
16 Quality Records    
 		      
17 Internal Quality Audits    
 		      
18 Employee Training and Qualifications    
 		      
19 Servicing - NA    
 		     X
20 Statistical Techniques    
 		      

Status
AD Adequate
UN Unacceptable (information is not adequate or the item has not been addressed)
CR Critical element
NA Not Applicable
OT All others

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