Clause 6.6: Externally Provided Products and Services (Clause 6.6.2)

Clause 6.6.2 of ISO/IEC 17025:2017 ensures that food testing laboratories maintain control over the external products and services they trust on. The laboratory must have procedure and also retain record with respect to the externally provided products and services. 

a)     Defining, reviewing, and approving the laboratory’s requirements for externally provided products and services:

The laboratory must clearly specify what it needs from external providers. This includes the technical specifications, performance requirements, and compliance with regulatory standards, calibration of equipment, participation in the proficiency testing round. These requirements must be reviewed and approved before engaging with a supplier.

1. Defining Requirements:
The food testing lab needs reagents, such as nitric acid or acetonitrile, for conducting HPLC analysis. To ensure accurate and reliable results, the lab specifies the following requirements to the vendor:

1. Purity levels: Reagents must be of HPLC grade to prevent contamination and interference in the analysis.
2. Certificate of Analysis (COA): Each batch must come with a COA from the supplier, verifying the purity and quality of the reagent.
3. Storage conditions: The reagents must be delivered and stored under specified conditions (e.g., temperature-controlled, tightly sealed containers) to maintain stability.

2. Supplier Selection:
The lab evaluates potential suppliers based on their ability to meet these requirements.

1. Criteria may include past performance, pricing, and delivery timelines.
2. The selected supplier is added to the approved supplier list after meeting these criteria.

3. Verification on Delivery:
Upon receiving the reagents, the lab verifies that:

1. The product matches the specifications mentioned in the purchase order (e.g., HPLC grade).
2. The COA is included and valid.
3. Packaging and labeling meet the lab’s requirements (e.g., batch numbers, expiry dates).

If the reagent does not meet the specifications (e.g., incorrect grade or damaged packaging), the lab rejects the batch and contacts the supplier for replacement or corrective action.

4. Monitoring and Re-Evaluation:
The lab keeps track of the supplier’s performance over time, including:

1. Consistency in product quality.
2. Timely delivery.
3. Responsiveness to issues or complaints.

If any problems persist (e.g., repeated delivery of substandard reagents), the supplier is re-evaluated and may be removed from the approved supplier list.

 

b) Defining criteria for evaluation, selection, monitoring, and re-evaluation of external providers:
The lab must establish a process to select reliable suppliers, monitor their performance, and periodically reassess them to ensure ongoing compliance.

1. Defining Requirements:

The lab identifies the need for an Atomic Absorption Spectrophotometer (AAS) for tasks like detecting heavy metals in food. Before purchasing, the lab defines specific requirements, such as:

                           i.          Technical specifications: Sensitivity, detection limits, and compatibility with analytical methods (e.g., flame or graphite furnace atomization).

                         ii.          Compliance: The equipment and vendor must meet the lab requirements.

                       iii.          After-sales support: The vendor must offer installation, training, regular maintenance, and technical support.

2. Vendor Evaluation:
   The lab evaluates multiple vendors against criteria such as:

1. Customer reviews: Feedback from other labs regarding the equipment’s performance and vendor reliability.
2. Service agreements: Availability of warranties, annual maintenance contracts (AMC), and repair services.

3. Purchase and Installation:
   After selecting the vendor, the lab proceeds with the purchase. Upon delivery, the lab ensures:

1. The equipment matches the specifications stated in the purchase order.
2. The vendor provides user manuals, and training for staff.

4. Performance Monitoring:
   The lab tracks the performance of the AAS and the vendor over time through:

1. Maintenance records: Ensuring timely preventive maintenance and resolving breakdowns quickly.
2. Response times: Monitoring how promptly the vendor addresses technical issues or provides spare parts.
3. Support quality: Evaluating the effectiveness of training and ongoing technical assistance.

5. Re-Evaluation of Vendor:
   If the vendor fails to provide adequate support (e.g., delayed repairs or poor services), the lab may:

                                               i.          Issue a formal complaint to the vendor.

                                             ii.          Evaluate other vendors for future purchases or service agreements.

                                           iii.          Document the performance issues for audit and decision-making.

  c) Ensuring that externally provided products and services conform to the laboratory’s requirements (or ISO 17025 requirements) before use or provision to customers:

The lab must verify that all externally sourced items meet its requirements before they are used in tests or analysis.

• Example: If the lab outsources microbiological testing for pathogens (e.g., Salmonella), it must ensure that the external lab is accredited to ISO/IEC 17025 and provides results in the required format.

 

d) Taking actions based on evaluations, monitoring of performance, and re-evaluations of external providers:

If an external provider fails to meet the required standards, the lab must take corrective action. This may include issuing warnings, requesting corrective actions, or switching to a different provider.

• Example: If a vendor consistently delivers contaminated solvents, the lab might issue a complaint and temporarily stop procurement until the issue is resolved. If the issue persists, the lab may remove the vendor from its approved supplier list.