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

1 MANAGEMENT RESPONSIBILITY

The supplier's management must define and document its policy and objectives for, and commitment to, quality. The supplier must ensure that this policy is understood, implemented and maintained at all levels in the organization.

The responsibility, authority and the interrelation of all personnel who manage, perform and verify work affecting quality shall be defined.

The supplier must appoint a management representative who, irrespective of other responsibilities, shall have defined authority and responsibility for ensuring that the quality system is implemented and maintained.

The quality system must be reviewed at appropriate intervals by the supplier's management to ensure its continuing suitability and effectiveness. Records of such reviews shall be maintained.

The results of such quality system reviews with respect to it's performance and impact should be made known to employees on a regular basis.

2 QUALITY SYSTEM

The supplier must establish and maintain a documented quality system as a means of ensuring that product/service delivery conforms to specified requirements. This shall include:

a) documented quality system procedures and instructions in accordance with the requirements of the Generic Quality Manual;

b) the effective implementation of the documented quality system procedures and instructions; and

c) documentation of the system to revise the quality system when necessary.

The documented quality system should be approved by the designated Quality Manager.

Have the employees received adequate education and training regarding the policy objective?

Has the inter-relation of personnel been identified through the use of an organizational chart?

Has the management representative selected to ensure implementation, and maintenance of the quality system requirements been identified in the Quality Manual?

Is the pedigreed seed crop inspection system being reviewed by senior management to check on its implementation and/or effectiveness or suitability at regular intervals?

Are review records maintained?

Are records of corrective actions maintained?

Are employees informed of the results of quality system reviews?

Does the quality manual indicate, directly or by reference to internal procedural documents, that there is a documented system for pedigreed seed crop inspection?

Have procedures manuals and instruction sheets been prepared?

Is there a system to revise and update the quality manual and quality system?

Does the quality manual indicate that a manager has signed off the quality manual and quality system?

5 DOCUMENTATION

5.1 General

The supplier shall establish and maintain procedures to control all documents and data that relate to the requirements of the Authorized Seed Crop Inspection program and the inspection of seed crops. These documents shall be reviewed and approved for adequacy by authorized personnel prior to issue. This control shall ensure that:

1. the current versions of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed; and
2. obsolete documents are promptly removed from all points of issue or use.

5.2 Operational Procedures

Ensure that operational procedures are reviewed by relevant authorized person for adequacy and conformance and filed in an accessible area.

5.3 Travellers (routing sheets, work sheets)

Any travellers shall be reviewed prior to issue to ensure the work is performed in accordance with user requirements.

Do the procedures ensure that external documents such as the Seeds Act and Regulations, and Circular 6, are up-to-date?

Is the responsible person listed in the organization chart?

Do the document control procedures ensure that relevant documents are made available to their correct locations?

Do the document control procedures identify current version of documents, and preclude the use of non-applicable documents?

Are changes to documents reviewed and approved by same person who originally reviewed and approved the documents?

Does this person have access to the necessary information on which to base the review and approval?

Does the documentation indicate that travellers are reviewed prior to issue?

Does the relevant authorized person ensure operational procedures are reviewed?

6 PURCHASE CONTROL

The supplier shall ensure that purchases that influence final product/service delivery conform to specified requirements of the Seeds Act and Regulations, and Circular 6.

The supplier shall select sub-contractors on the basis of their ability to meet crop inspection requirements, including quality requirements. The supplier shall establish and maintain records of acceptable vendors and sub-contractors.

The selection of vendors and sub-contractors, and the type and extent of control exercised by the supplier, shall be dependent upon the type of product and, where appropriate, on records of vendors and sub-contractors' previously demonstrated capability and performance.

Purchasing documents shall contain data clearly describing the product ordered, including, where applicable,

1. the product/ service standards;
2. the testing and certification requirements;
3. the official documentation requirements.

The supplier shall review and approve purchasing documents for adequacy of specified requirements prior to release.

Purchased product may be verified by the supplier or customer upon receipt or at the source.

Is the person responsible for purchase orders identified on the organization chart?

Does the quality manual outline a system for choosing satisfactory vendors and sub-contractors, based on:

• review of past performance in supplying similar products/ services.
• ability to meet the pedigreed seed crop inspection requirements?

Are the results from the inspection, seed testing and resultant grade used to rate vendors and sub-contractors?

Are records of acceptable vendors and sub-contractors kept?

Is there an indication that purchasing documents clearly describe all the technical and documentation requirements to ensure the purchased product/service meets the requirements?

Are purchasing documents reviewed and approved for adequacy prior to their release?

7 CUSTOMER SUPPLIED PRODUCT

The supplier must establish and maintain procedures for verification, storage and maintenance of customer supplied product. Any such product that is lost, damaged or otherwise unsuitable for use shall be recorded and reported to the customer.

NOTE - Verification by the supplier does not absolve the customer of the responsibility to provide acceptable product.

Are the pedigreed seed crop inspection procedures provided by your clients the same as those supplied by other vendors?

Are the disposal methods for non-conforming product similar to all other vendors?

8 PRODUCT IDENTIFICATION AND TRACEABILITY

The supplier must establish and maintain procedures for identifying the parental material and progeny during all stages of production, delivery and use.

Where, and to the extent that, traceability is a specified requirement, individual product or batches shall have a unique identification. This identification shall be recorded.

9 PROCESS CONTROL

The supplier shall identify and plan the production and, where applicable, installation processes that directly affect the quality of the seed produced.

Operational procedures must be reviewed for adequacy and conformance with controlled conditions such as OECD, CSGA, and AOSCA seed crop standards.

There must be a system to assure that each procedure is being applied as intended to meet the required quality standard.

Qualification requirements of personnel performing processes under controlled conditions must be documented, and records of qualified processes and personnel maintained.

Have operational procedures been reviewed for adequacy and conformance to the appropriate controlled conditions?

Is a system in place to assure that each procedure is being applied as intended?

Is there documentation outlining the qualification requirements for personnel and records of current qualified processes and personnel?

10 INSPECTION AND TESTING

10.1 General

The supplier shall establish and maintain documentation for inspection and testing activities in order to verify that product meets the specified requirements.

10.2 Receiving Inspection

The supplier shall ensure that parental material and any progeny of seed multiplication are not used until it has been verified as conforming to specified requirements. Verification shall be in accordance with Circular 6 and documented procedures.

NOTE: Positive recall procedures (permitting use of product prior to the conformity assessment if recall procedures are in place) are not allowed.

10.3 Final Inspection

Documentation should outline procedures to follow for inspection of final seed to ensure conformance with quality plan.

10.4 Inspection and Test Records

The supplier shall establish and maintain records that give evidence that the product has passed inspection and/or test with defined acceptance criteria.

Authority responsible for release of the product should be indicated in the quality plan.

Where necessary, do the procedures comply with Circular 6/ OECD requirements?

Verify that the service stores the work sheets, the release decision and all necessary testing and certification documents for each lot of parental material, where applicable. See section 15.

Is there coordination with sections 12 (Inspection and Test Status) and 8 (Product Identification and Traceability) where required?

Is the inspection of pedigreed seed crop in conformance with the quality plan and SWI?

Verify that the service stores the work sheets, the release decision and all necessary testing and certification documents for each lot of final product, where required. See section 15.

As a minimum, the service must retain rough notes/work sheets, reports of crop inspection and any additional records and reports pertaining to the inspected crop as well as records pertaining to varietal purity testing.

11 INSPECTION, MEASURING AND TEST EQUIPMENT

The supplier shall maintain a system for selecting, using, calibrating, and controlling equipment used to measure and test seed. This includes, physical standards, and devices used to control and verify service quality.

Note - Any measurement or testing service that has been sub-contracted by the supplier must also meet the requirements of this standard.

All purchased equipment must be examined upon receipt to ensure that it complies with these requirements.

All equipment must be adjusted at the time of purchase, and undergo regular maintenance according to an established standard in the quality plan. Records of all adjustments and maintenance must be kept for each piece of equipment.

Authorized person(s) responsible for overseeing maintenance of equipment should be indicated in the quality plan.

Ensure that requirements for sub-contractors are covered under section 6.

Is a system to verify that new equipment meets standards in place?

Verify that the system stores the records of adjustment and maintenance for each piece of equipment.

Is (are) the person(s) responsible indicated in the documentation?

12 INSPECTION AND TEST STATUS (where appropriate)

The inspection and test status of the seed crop shall be readily identified by using markings, authorized stamps, tags, labels, routing cards, physical location or other suitable means. Such identification should permit easy review for compliance with the crop standards, and indicate the conformance or non-conformance of product with regard to inspection and tests performed.

Records shall identify the inspection authority responsible for the inspection and test status of conforming product.

Is there a system of identification of the inspected pedigreed seed crop's test status and the conformance/ non-conformance with the crop standards based on CSGA appraisal? The status can be identified using stamps, tags, markings, labels, or routing cards.

Are products that meet the specified requirements clearly distinguished and identified from the products that do not meet the specified requirements (see section 13)?

Is the inspection authority responsible for the inspection and test status of the conforming product identified?

13 CONTROL OF NON-CONFORMING PRODUCT

The supplier shall establish and maintain procedures to ensure that product which does not conform to specified requirements is prevented from inadvertent use. Control shall provide for identification, documentation, evaluation, segregation (when practical) and disposition of non-conforming product, and for notification to the responsible individuals.

A recall system should be in place for distributed product when a non-conformance is identified. Records of recalls must be maintained.

The responsibility for review and authority for the disposition of non-conforming product shall be defined.

Does the system:

• ensure that non-conforming material is identified, documented and segregated,
• prevent the inadvertent use of non-conforming product,
• evaluate the nature of non-conformance,
• take appropriate action for the disposition of non-conforming product,
• maintain records of the process?

Is a recall system in place?

Are records of recalls kept for a specified period?

Is the person in charge of disposing of nonconforming material named? The disposition system shall have the concurrence of the quality representative and the relevant management personnel.

14 CORRECTIVE AND PREVENTIVE ACTION

The supplier shall establish, document and maintain procedures for:

1. investigating the cause of non-conforming product and the corrective action needed to prevent recurrence;
2. analysing all processes, work operations, quality records and service reports to detect and eliminate potential causes of non-conforming product;
3. initiating preventative actions to deal with problems;
4. applying controls to ensure that corrective actions are taken and that they are effective;
5. implementing and recording changes in procedures resulting from corrective action.

• investigate causes of non-conformances;
• notify the areas concerned;
• develop a corrective action plan to prevent recurrence;
• analyse available information to identify and eliminate potential causes of non-conformances;
• take corrective action to prevent recurrence;
• monitor/and follow-up on corrective action; implementation and its effectiveness;
• maintain records of corrective action;
• identify the time period for resolution of problems.

Does the manual establish responsibility and authority for corrective action and describe how this action shall be carried out?

15 HANDLING AND STORAGE

The supplier shall establish, document and maintain procedures for cleaning, preserving, segregating and handling product from the time of receipt of parental material to the final seed. This will include the handling of discarded portions of the seed crop and segregation from the portion harvested for seed.

Stored items shall be checked periodically for condition and shelf life

Documentation shall indicate a minimum storage time for samples of all parental material and final seed. Disposal of samples shall be documented according to the quality program, the customer, and the necessary safety and health provisions.

Do the procedures keep non-conforming seed separate from the rest of the inventory (section 13)?

Verify that stored items are checked.

Verify that samples of parental material and final seed are maintained for a specified period, and disposed of in accordance with the quality plan.

16 RECORDS

The supplier shall establish and maintain procedures for identification, collection, indexing, filing, storage, maintenance and disposition of quality records.

Quality records shall be maintained to demonstrate achievement of the required quality and the effective operation of the quality system. Pertinent sub-contractor quality records shall be an element of these data.

All quality records shall be legible and identifiable to the product involved. Quality records shall be stored and maintained in such a way that they are readily retrievable in facilities that provide a suitable environment to minimize deterioration or damage and to prevent loss. Retention times of quality records shall be established and recorded. Where agreed contractually, quality records shall be made available for evaluation by the customer or his representative for an agreed period.

Is the crop inspection documentation retained, indexed, filed and stored?

Are the records stored so as to prevent damage and deterioration?

Is there a record retrieval system?

Records are to be legible and identifiable to the relevant parental and harvested material.

Are the retention times of the records equal to one year?

Are corrections to records made in a controlled manner as outlined in the quality plan?

Are the records disposed of by authorized persons?

17 INTERNAL QUALITY AUDITS

The supplier must carry out a comprehensive system of planned and documented internal quality audits to verify whether the crop inspection control system complies with planned arrangements and to determine the effectiveness of the quality system. The audits and follow-up actions should be carried out in accordance with documented procedures.

The audits shall be performed by personnel assigned by senior management and shall be indicated in the quality plan.

The results of the audits should be documented and brought to the attention of the personnel having responsibility in the area audited. The management personnel responsible for the area should take timely corrective action on the deficiencies found by the audit.

Is(are) the assigned person(s) indicated in the quality plan?

Are the audit findings documented and communicated to the responsible personnel as well as management for timely corrective action?

18 EMPLOYEE TRAINING AND QUALIFICATIONS

The supplier shall establish and maintain procedures for identifying the training needs and provide for the training of all personnel performing activities affecting quality. Training shall be provided on an ongoing basis and include health and safety aspects, relative to the service tasks being performed. Personnel performing specific assigned tasks shall be qualified on the basis of appropriate education, training and/or experience, as required.

Appropriate records of training, awareness, and qualification shall be maintained.

Training should be undertaken for multiple employees to ensure continuity of service during absences.

Is training provided for all personnel whose activities affect crop inspection - see organization chart?

Further, have warehouse staff received training regarding sections 11 and 15 of the manual?

Are records of training activities and qualification maintained?

Does training provide for overlap of skills?

19 SERVICING

NA

20 STATISTICAL TECHNIQUES

The supplier shall indicate process characteristics that will require statistical techniques for, the assurance and control of quality and, the acceptance or rejection of lots.

Selected statistical techniques and the basis for their selection shall be outlined in the quality plan.

The travel pattern for crop inspection must comply with QSP 142.1.

Count areas must be appropriate for 10000 plants.

Statistical techniques must be reviewed and monitored to ensure that specified requirements are met.

Verify that selected statistical techniques and the rationale for their selection are included in the quality plan.

Does the travel pattern comply with QSP 142.1?

Are the count areas used appropriate?

Is there a system in place to monitor and review statistical techniques?