nonconforming product

The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in documented procedure.

Does a documented procedure exist indicating control and related responsibilities and authorities for dealing with nonconforming product?

The organization shall deal with nonconforming product by taking action to eliminate the detected nonconformity .

Obsolete product shall be controlled in a similar manner to nonconforming product.

The organization shall deal with nonconforming product by taking action to preclude its original intended use or application.

Scrap: action on a nonconforming product to preclude its originally intended use. EXAMPLE Recycling, destruction.

Nonconforming product: referring to products not satisfying specified requirements.

rework, repair can affect or change parts of the nonconforming product.

Marketing Department is in charge of the nonconforming product control in the process of finished product delivery.

This element shall apply to suspect material or product (see Glossary) as well as nonconforming product.

The manufacturer shall ensure that nonconforming product is accepted by concession only IF regulatory requirements are met.

Person who finds the nonconformity shall segregate the identified nonconforming product.

Responsible for organization of nonconforming product review .

Has the responsibility and authority to stop nonconforming product.

Customers shall be informed promptly in the event that nonconforming product has been shipped .

Are audit records kept? Is nonconforming product appropriately identified and controlled to prevent its unintended use or delivery?

Nonconforming product: not meet the expected or regulated requirements.

Person who detects the nonconformity shall record the status of nonconforming product.

Be authorized to disposition nonconforming product and material.

Investigate the root causes of nonconforming product and identify the corrective actions needed to prevent a recurrence.

This procedure is to control our nonconforming product to prevent its unintended use or delivery.

H. Buy nonconforming product control processing.

Has the duty and authority to shutdown any operation producing nonconforming product.

Have the power to prohibit any nonconforming product to flow into next step of station.

The people who detect nonconforming product are responsible for segregating the nonconforming product.

Error Proofing---The use of process or design features to assure nonconforming product.

NOTE Unlike rework, repair (3. 6. 9) can affect or change parts of the nonconforming product.

Unlike rework (3. 6. 7), repair can affect or change parts of the nonconforming product.

Error-proof your control of the nonconforming product process so that nobody has to assume anything.

Operating instructions: 3, need to master the key problem how to record, report nonconforming product.

General handling process Find nonconforming product Isolate nonconforming product Confirm

To identify, segregate and mark the nonconforming product, and analyze causes on non conformities;

The organization shall deal with nonconforming product by one or more of the following ways:

The principle for disposal of nonconforming product

action on a nonconforming product (3. 4. 2) to make it acceptable for the intended use

action on a nonconforming product (3. 4. 2) to preclude its originally intended use