Supplier quality agreement checklist

What a quality agreement is

A purchase order covers price, quantity and delivery. A supplier quality agreement covers how quality will be assured: which specifications apply, who approves changes, what happens when a nonconforming part is found, which records are kept and for how long, and who may audit. It is usually a separate document that the purchase order refers to, signed by both parties and reviewed at set intervals. Regulated industries expect one; for a medical device manufacturer, ISO 13485 purchasing controls call for a written agreement that the supplier will notify changes before they are made.

The elements

The standard list in the tool covers what reviewers most often look for. The ones that cause the most trouble when they are vague:

• Change notification and approval. Which changes need notice (material, process, equipment, site, sub-tier source), how much notice, and whether your approval is needed before a changed part ships.
• Nonconforming product. How fast the supplier must tell you about a suspect shipment, how containment works, and how deviations are requested and approved.
• Corrective action. Response times for containment, root cause and closure of a SCAR, usually in 8D format.
• Sub-tier control. Requirements must flow down to the supplier's own suppliers, or the agreement stops one level short of where many problems start.
• Right of access. Your right, and your regulator's, to audit the supplier's site and records.
• Counterfeit prevention and traceability. Critical in aerospace, defense and electronics, and for any product that may need a recall.

How the score works

Each element is marked critical, important or standard. Critical elements count three times, important twice and standard once. An element covered fully earns full credit, partly earns half, and missing earns none. Elements marked not applicable, or not yet reviewed, are left out of the score. The score is the weighted credit divided by the weighted total.

A high score is not enough on its own: an agreement is ready to sign only when every critical element is fully covered, every element has been reviewed, and the score meets the threshold you set. A 95% agreement that is silent on change notification is not ready.

Change notification terms

The notice period has to be at least as long as it takes you to requalify the part: a new first article, a PPAP or a validation. The tool compares the two and flags the gap, and flags agreements that ask only for notice where your approval should be needed. For assessing a change once it is notified, use the engineering change impact checklist.

Review and approval

Quality agreements usually pass through several levels of review: supplier quality, engineering, purchasing, legal, and the supplier's own signatory. Finalization controls make sure the version signed is the version reviewed, that comments are resolved, and that the purchase order refers to the current revision. The approvals table records each one.

Once signed, performance against the agreement's metrics belongs on the supplier scorecard.

On the exam

Quality agreements are CSQP I.D.3 (analyze the elements, including other levels of approval and review). The same section covers terms and conditions (I.D.1), supplier agreements (I.D.2) and finalization controls (I.D.4). Change notification also appears under supplier communication (V.A.3) and confidentiality and organizational policies (VII.C.1), and counterfeit prevention under II.A.3. For CMDA, purchasing controls are III.D.4. Expect to pick the missing element from an agreement, or the clause that would have prevented a given escape.

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