ISO 9001-Clause 8.3

ISO 9001-Clause 8.3 Control of nonconforming product

ISO 9001 Requirement
The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming product.
Where applicable, the organization shall deal with nonconforming product by one or more of the following ways:
a) by taking action to eliminate the detected nonconformity;
b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;
c) by taking action to preclude its original intended use or application;
d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.
When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).

Explanation:
ISO 9001-Clause 8.3 defines Nonconforming product  as product that does not conform to customer requirements, applicable regulatory requirements or your own organization requirements. The definition may also apply to nonconforming processes and services. Nonconformities may relate to suppliers and outsourced work, your own organizational activities or product shipped to customers. Your documented procedure for nonconforming product must include controls and responsibilities to  identify, contain i.e. prevent further processing or use, keep records of the nature and other details of the nonconformity, notify appropriate personnel and customer, where appropriate, evaluate what disposition action needs to be taken, carry out timely disposition, determine policies for release for further processing or shipment to the customer, obtain customer concessions, rework and re-verification, establish performance indicators to measure the effectiveness of the control of nonconformance process, etc.
Product or material found with no identification or its quality status is not known, should be treated as nonconforming product and controlled by the above procedure. If you find that nonconforming product has been shipped, without a customer concession, you must take appropriate action to reduce the immediate and consequential effect of the nonconformity. Depending upon the seriousness and scope of the nonconformity, you might consider taking action to eliminate the nonconformity as well as corrective action to eliminate the root causes of the nonconformity. While there may be  no requirement to notify the customer, it might be appropriate in specific circumstances to notify the customer and resolve the situation to your customer’s satisfaction. A similar rationale may be applied where product has been shipped that does not meet regulatory requirements. Depending upon the seriousness and scope of the nonconformity, you might consider taking action to eliminate the nonconformity as well as corrective action to eliminate the root causes of the nonconformity. You need to be aware of any reporting requirements imposed by regulatory bodies and comply with them.
A concession authorization allows you to ship nonconforming product, under controlled conditions. A deviation authorization allows you to manufacture product different from the original specification, under controlled conditions. In both these situations, make sure that you obtain these authorizations in writing prior to shipping or manufacturing nonconforming product. All product realization processes must show the interaction with your process for nonconforming product. Performance indicators to measure the effectiveness of control of nonconforming product may include  reduction in cycle time to evaluate and dispose of nonconforming product, reduced errors in preventing unintended use or delivery, improved alternate use of nonconforming product and cost recovery, etc.
Audit Checklist:

  • Is there a procedure in place to control nonconformances?
  • What makes a Product/Service nonconforming?
  •  Is a record kept when a product/service nonconformance occurs?
  •  Who initiates the record? Who decides how to resolve nonconformances?
  •  Do you currently have any unresolved nonconforming products/services?
  •  If a nonconforming product is reworked, is it re-checked? How is this done for nonconforming services?
  •  Who has the authority to decide if a nonconformance can be left as is? Has this ever occurred?
  •  Were there any situations in the last 12 months where nonconforming product or service was discovered after delivery?
  •  Over the past 12 months have there been any returns from Customers (or credits issued)? Any of them due to a nonconformance? How were they handled?

Mandatory Procedure : Procedure for control of non conforming Product

pdf Example of Procedure for control of non conforming Product

Mandatory record: Nature of the product nonconformities and any subsequent actions taken, including concessions obtained for e.g. Non Conformance Record, Concession Record

pdf Example of format for Product N.C Register

Implementation document ( Not mandatory but helps in fulfillment of requirement): 

  • Non conforming tags
  • Segregated hold areas
  • Non conforming material report
  • Disposition (what we do with it)
  • Corrective action report
pdf Example of format for Cause Effect Analysis

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