Purchasing and Receiving

Requirement-4.2.1, 7.4.1 and 7.4.2-Supplier Selection and Performance

Management Process
Comment on their suppliers ability to supply product in Comments/Evidence/Findings?
accordance with the organizations requirements. How
does the facility control the purchasing processes?

Criteria for selection, evaluation, and re-evaluation are Comments/Evidence/Findings?

established

Records of evaluations and actions arising from the Comments/Evidence/Findings?

evaluations are maintained. THIS IS A REQUIRD ISO
RECORD.

Document/Purchase Order Supplier Date Last Supplier Required to Keep Records? Defined
Evaluated How?

Complete table for the suppliers selected and identified above.

Identify Product Name and Yes(y) / No(n) / Not Applicable (n/a) for Each Column.
All No Identifiers shall require a finding to be raised and details provided therein. Use additional pages if required.
Sample Selected (Referenced Above)
Requirement #1 #2 #3 #4 #5 #6
Have Criteria for Selection/Evaluation Been Defined? (7.4.1/7.4.1.2)

Have Criteria for Re-evaluation of Suppliers Been Defined? (7.4.1/7.4.1.2)

Have Evaluations been Performed and Results Maintained? (7.4.1)

Supplier Records Maintained?

Are They Legible? Identifiable? Retrievable? Protected?

Complete table for the purchase orders selected and identified above. Identify
Product Name and Yes(y) / No(n) / Not Applicable (n/a) for Each Column.
.
Sample Selected (Referenced Above)
Requirement #1 #2 #3 #4 #5 #6
Does Purchasing Information Describe Product (7.4.2)?:
 Adequacy of purchase requirements prior to issuance

Purchase Order Records Maintained?

Requirement: 7.4.3-Verification of Purchased Product

Identify the activities established and implemented to Comments/Evidence/Findings?

ensure that purchased product meets specified purchase
requirements

A process of product recall is implemented when product Comments/Evidence/Findings?

released for use prior to completion of required incoming
verification

Requirements for supplier delegations defined and a Comments/Evidence/Findings?

register of delegations maintained

Purchasing information defines information about the Comments/Evidence/Findings?

verification activities at the supplier's premises

Select a representative (minimum of 3) purchased products.

Document/Purchase Order Supplier

1.

2.

3.

4.

5.

6.

Complete table for the purchased product selected and identified above.
Identify Product Name and Yes(y) / No(n) / Not Applicable (n/a) for Each Column. .
Sample Selected (Referenced Above)
Requirement #1 #2 #3 #4 #5 #6
 Have Criteria for Receiving Inspection Been
Defined? (7.4.3)
Have Criteria for Receiving Inspection Been Met?
(7.4.3)
Verification / Receiving Records Maintained

Additional comments/audit evidence regarding Purchasing activities and explain all No responses from
above:

Requirement: 7.5.3- Identification and Traceability-Receiving

What processes have been implemented to ensure Comments/Evidence/Findings?
product identification throughout Receiving Process?

Where traceability is a requirement, how is it controlled Comments/Evidence/Findings?

and recorded? .

How does production know it is okay to use the material? Comments/Evidence/Findings?

Requirement: 7.5.4-Customer Property-Receiving

The organization shall exercise care with customer Comments/Evidence/Findings?
property while it is in the organizations control. (Note:
Customer Property can include intellectual property). Describe the
processes established to ensure that customer property
is:

- Identified?

- Verified?

- Protected/Safeguarded?

Requirement: 7.5.5-Preservation of Product -Receiving

The organization shall preserve the conformity of the Comments/Evidence/Findings?
product and constituent parts during internal processing
through delivery to the intended destination. Describe . .
the controls and processes established and implemented
to:

Consider:

Cleaning
Special handling for sensitive products
(ESD)
Marking and labeling
including safety warnings
Shelf life control and
stock rotation
Special handling for hazardous materials

For each type of product or material, review at least three examples. Ensure the product is identified, its inspection stat
is known, and if traceability is required, the process is being followed: (Pick 3 Examples)

Applies Item Record Specific Identified? Inspection Traceability

Items Reviewed Status Exists (if
Known? required)?

Additional comment regarding the effectiveness of how product is identified.