D-117

Laboratory Purchases and Receiving

Section D — Laboratory Operations and Specifications Revision 0 7 pages

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1.0 Purpose

The objectives of the Purchasing process are to ensure that purchased products and services are

provided in accordance with specifications and/or requirements. This will ensure that needed
items arrive in a timely manner, without quality problems, and at the best possible cost and that
outsourced services are provided as necessary. The objective of the General Receiving process
is to verify that purchased items are verified to meet the requirements as stated on the Purchasing

documents prior to use and purchased services satisfy lon Lab’s requirements.

2.0 Scope

This procedure applies to purchased products and services that affect the quality of Ion Labs
services and processes, and to suppliers and subcontractors providing products and services
affecting the service quality.

3.0 Responsibility

3.1 This procedure is applicable to QC Laboratory Management or Analytical Development
Management, who performs procurement activities and the evaluation and approval of
suppliers and service providers.

3.2. This procedure applies to the receipt of purchased items delivered to the Ion Labs.

3.3 = ‘It is the responsibility of QC Laboratory management and personnel to verify incoming
goods against the purchasing requirements prior to making them available for use.

3.4 —‘ It is the responsibility of QC Laboratory Management to manage incorrect receipts and
communicate any issues to suppliers and service providers.

3.5 QC Laboratory Management is responsible for ensuring that this procedure is accurate,

understood, and implemented effectively. No changes may be made to this procedure
without the authorization of QC Laboratory Management.

4.0 Definitions

4.1 Supplier — For the purpose of this procedure, the term “supplier” includes any external
providers such as supplier, vendor, subcontractor, technical specialist or laboratory.

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4.2 Purchase Order- For the purpose of this procedure, “purchase order” includes any

document or method used to procure a product or service, including email
communications, on-line orders, direct credit card purchases, purchases at retail outlets,
or completed Purchase Orders.

4.3 CoC -— Certificate of Conformance

tf CoA — Certificate of Analysis

5.0 References

5.1 C-502, SOP, Record Storage, Retention, and Destruction

5.2 E-601, SOP, Vendor Qualification

5.3 D-202, SOP, Outsourced Testing Procedure

5.4 QS-108, SOP, Corrective and Preventative Action

6.0 Procedure

6.1 Process Inputs

6.1.1 Inputs to the Purchasing and Receiving process include, but are not limited to:

® Information for Lab supplies and purchasing needs required to conduct
and improve operations including outsourced calibration services,

proficiency testing, consulting, etc.

@ Records of placed purchases, incoming purchased products (Lab supplies
and consumables) and their accompanying packing lists (or equivalents)
and any supporting documentation (e.g., certifications).

6.2 Identification of Need

6.2.1 Test Methods and Equipment Manuals identify the items, equipment, and

consumables (products) that are required for the testing. The Approved Vendor
List identifies the supplier or vendor used.

6.2.2 Lab Management or Analytical Development Manager identifies the need to
procure calibration services or equipment for performing testing. Communication
to Calibration Service Suppliers will include the requirement for calibration to

traceable to national or international measurement standards. (NIST)

6.2.3 Management identifies the need to procure services such as consultants, contract

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auditors to perform internal audits, and other services necessary to support the

quality management system and accredited testing requirements.

6.2.4 Infrastructure and work environment procurement needs, supporting services, and
utilities are identified and provided by top management.

6.2.5 Any Lab employee may identify the need to purchase goods and services to
support, operate, or improve processes affecting quality.

6.2.6 The employee who has identified the need for a purchase of goods or services

contacts Lab Management or the Analytical Development Manager if a purchase
order will be required to complete the purchase. The employee will define the
requirements for the purchase and communicates to Lab Management or the
Analytical Development Manager (verbally or via a documented method such as

an email) a description of the needed goods and/or services and their quantities,
due dates, and other applicable information required for the Lab to receive goods
and/or services meeting the lab’s requirements. The employee requesting the
goods and/or service will be responsible for ensuring the technical content is

accurate.

6.2.7 Lab Management or the Analytical Development Manager will review the
information provided to ensure it is sufficient and that purchasing generates a
purchase order based on the information provided.

6.2.7.1 Approval of the lab’s requirements for the goods and/or services
purchased will be indicated by the generation of the purchase order.

6.2.7.2 The purchase order will be sent to the Supplier to communicate the
purchase requirements.

6.2.7.3 The purchase order will be the record of the purchase made, the defined
requirements and the review and approval of the lab’s requirements for
the purchase.

6.2.7.4 Subcontracted work for accredited testing is only placed with competent

laboratories. Competent laboratories can demonstrate compliance with
ISO 17025 requirements for the work provided. If accredited testing is
outsourced, Lab Management advises the customer of the arrangement in
writing (1.e., via email), and when appropriate, gains the approval of the
customer (preferably in writing as well).

6.2.7.5 Test Reports resulting from outsourced servicing are received and verified
before being released to the customer. Verification includes confirmation

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that supplied reports demonstrate conformity to specified requirement.

6.2.8 Where the employee will select goods and/or services using websites, catalogs,
or selection of in-stock items at a retail establishment, the employee will review
the information available for the required goods and/or services, compare the
information available to the established requirements, select the goods and/or
services which satisfy the defined requirements, and complete the purchase using

a credit card.

6.2.8.1 In these cases, no additional communication of requirements will be
necessary, as the supplier has communicated the specifications and claims
of performance for the goods and/or services on the website, within the

catalog, or on the shelf.

6.2.8.2 Approval of the lab’s requirements and the selected goods and/or services
will be indicated by the receipt generated in the transaction to document
the purchase.

6.2.8.3 The receipt will be the record of the purchase made, the defined
requirements, and the review and approval of the lab’s requirements for

the purchase. The employee making the purchase will be responsible for
assuring the goods and/or services purchased meet the lab’s requirements.

6.2.9 For all purchases where acceptance criteria (performance specifications which
will be used during inspection or monitoring of the goods and/or services
purchased) will be applied, the supplier will be informed of the acceptance criteria

during the purchasing process.

6.2.9.1 Where purchased services must be provided by personnel with specified
competence or qualifications, these requirements will be communicated
to the supplier.

6.2.9.2 If the Lab intends to perform verification, inspection, audits, or other

activities at the supplier’s premises, these activities will be communicated
to the Supplier. Methods of communicating this information may be
within purchase orders or in documented communication with suppliers
maintained by Lab Management.

Critical Consumables

6.3.1 Critical consumables are materials which directly affect the performance of

laboratory activities. Critical consumables will be identified in the contents of
established test methods or equipment manuals and by Management’s designation

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as critical to the consistency and effectiveness of laboratory operations. In
addition to the purchasing requirements listed above, this section of the procedure

describes additional controls which will be applied to critical consumables.

6.3.2 When ordering critical consumables, an appropriate certificate of analysis or
conformance is requested from the supplier when the critical consumable is
ordered if deemed appropriate by Lab Management or Analytical Development

Manager. This request may be documented on purchase orders where applicable,
or via personal contact, or in emails.

6.3.2.1 The certificate will be requested to be shipped with the critical
consumable. If the supplier cannot accommodate this request, an
alternative method may be provided by the Supplier, such as access to a

website where the certificate can be obtained.

6.3.2.2 The requirement for the certificate of analysis or conformance is indicated
in the product description in the purchase order or purchasing documents.

6.3.3 When ordering critical consumables, the details of the critical consumable will be
specified completely in the purchase order to ensure the proper critical

consumable is received. For example, both brand and generic names for
chemicals may be specified to ensure the proper critical consumable is received.

6.3.4 Additional work instructions necessary for the proper handling, storage, and/or
disposal of these consumables will be developed and made available as deemed
necessary by Lab Management or the Analytical Development Manager.

6.3.5 All consumables will be marked with the following information (of verified to be

present on the manufacturer’s label) or using an equivalent method while in
storage. Critical consumables will only be separated from these markings while
being used in the performance of laboratory activities:

& Identification of the critical consumable,

® Description of critical consumable and detailed specification if deemed
necessary, including both brand and generic names for any chemicals or
compressed gases,

ce Expiration date indicating the acceptable life of the critical consumable
for the laboratory,

@ Special storage requirements for the consumable to protect it from damage

and or deterioration.

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6.4 Order Changes and Cancellations

6.4.1 When purchase order requirements change (or are cancelled) for any reason, Lab

Management or designee will notify the supplier, vendor or service provider and
make the necessary changes in the Approved Vendor List. Revisions to
purchasing requirements are reviewed and approved in the same manner as new
purchases.

6.5 General Receiving

6.5.1 When a delivery arrives at Ion Labs, Receiving personnel inspect incoming
packages and items for damage while verifying the goods and their quantities
against their accompanying packing slips (or equivalents).

® If gross damage is apparent to an incoming shipment (e.g., damage to such

a degree that the goods are unusable), Receiving personnel with input
from Lab Management or the Analytical Development Manager as needed
determines the disposition. Such damage is noted in carriers’ logs before
their departure if possible.

@ If goods arrive without a packing list, receiving personnel confirm the
purchasing requirement and resolves the issue, as appropriate.

@ Incoming measuring equipment is processed according to the Calibration
and Equipment Control procedure.

6.5.2 Receiving lab personnel verifies the purchased item(s) meet all applicable
requirements of the purchase information by comparing the information on the

packing list to the information on the purchase order submitted to the external
provider.

6.5.3 Products failing the above verifications are treated as discrepant. The product is
segregated until the issue is resolved with the supplier or vendor. Records of

products returned to suppliers are maintained.

6.5.4 Receiving personnel or Lab Management resolves all product or count
discrepancy and nonconforming product issues with suppliers and vendors, and
where appropriate issues corrective actions in accordance with QS-108 Corrective
and Preventative Action procedure.

6.5.5 Receiving forwards copies of Certificates of Conformance or Certificates of

Analysis to the Lab Director and/or the Analytical Development Manager for their
review. The signature and date will indicate the acceptance of the CoC or CoA.

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The hard copy CoC or CoA will be filed in the appropriate hard copy binder.

6.5.6 Receiving records are controlled in accordance with the SOP C-502 Record

Storage, Retention, and Destruction.

6.6 Record Management

6.6.1 Records are maintained per SOP C-502 Record Storage, Retention, and
Destruction.

6.7 Process Outputs

6.7.1 Outputs to the Purchasing and Receiving process include, but are not limited to:

@ Approved purchasing documentation,

8 Purchased products, and services meeting documented procurement
requirements,

® Accepted and stored product and evidence of verification.

8.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 10/01/21 | New procedure. N/A J. Sassman | - | - |