Nonconforming Product

ISO 9001 section 8.3 Control of nonconforming product states: “The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.”  The standard requires that a specific procedure be written that describes how nonconforming product is controlled.

Simply put, the standard is saying: Don’t mix the good stuff with the bad stuff.  Defective material should be placed in an area specifically designated for nonconforming product.  That area should be segregated from good product and specifically labeled as nonconforming product.

The product placed in that area must be labeled, and its nonconformances identified.  It is common for organizations to generate a report that identifies and describes the defective product.  These reports go by many names such as Discrepant Material Report (DMR), Nonconformance Report (NCR), etc.  They typically identify the product, the discrepancy or discrepancies, and the number of pieces involved.  The form is also used to identify the actions taken, who authorized the actions, and what the final disposition of the material was.  The standard allows the following actions:

• Rework the product to specification
• Use as is (“authorizing its use, release or acceptance under concession”)
• Scrap
• Re-grade for some other purpose

My personal opinion is that ‘Use as is’ should be avoided if at all possible.  It has the following problems:

• An inferior product is gets shipped to customers
• A message is sent to employees that defects are acceptable

When product is reworked, it must be inspected for the defect originally identified. 

The discrepancy report, indicating the actions taken and the final disposition is a record which must be maintained.  Periodically records of nonconforming product should be analyzed.  Analysis might identify possible preventive actions that could reduce nonconformances in the future.

For more information visit www.rosehillsystems.com .

Supplier Evaluations

ISO 9001 section 7.4.1 states: “The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements.  Criteria for selection, evaluation and re-evaluation shall be established.  Records of the results of evaluations … shall be maintained.”

Some customers use site visits to assess the capabilities of the supplier, but ISO 9001 does not specifically require this practice.  Most customers send potential suppliers a self-assessment questionnaire.  Self-assessment questionnaires can be simple or complicated to complete.  Be aware that the likelihood of receiving a response to a questionnaire is inversely proportional to the questionnaire’s complexity.

I’m not in favor of complicated multi-page questionnaires in most cases.  If the organization intends to place a small order with a supplier it is not likely to use often, it is unlikely that a complex questionnaire will be returned in a timely manner, if it is returned at all.  A simple, short questionnaire is more likely to be completed and returned.

If the supplier is to be a key supplier with a significant business opportunity, and a likely long term business arrangement, it may be better to visit the supplier and complete a complex questionnaire yourself in an on-site audit.  Meeting the players creates a better, more lasting relationship with the individuals involved.  These relationships make problem solving over the phone or by e-mail more likely to be successful.   As to what questions to ask, Govind Ramu presents an interesting perspective, in the Expert Answers section of   Quality Progress March, 2013 where he addresses questions to ask and not to ask a supplier.

Consider establishing (and documenting) multiple criteria any of which will qualify the supplier.  Examples might be:

·         ISO 9001 certified

·         Over one year experience with the supplier with few product rejections

·         Franchised supplier (for distributors)

As you collect supplier qualification data, consider storing the responses in a database.  The database facilitates contacting suppliers when quality problems arise and provides a tool for re-evaluating the supplier.  I recommend contacting the supplier near the time when his certification expires, and if it is not certified, annually.  A database can facilitate and automate this work.

Key suppliers, those suppliers who get most of your business, should be rated by some rating system routinely.  The ratings should be fed back to the supplier.  Examples of such ratings might be:

·         On time delivery percentage

·         Number of lots rejected divided by the number of lots received.

·         A multiple of the two above.

For an example of a simple questionnaire visit www.rosehillsystems.com and click on Tools.

Preventive Action

Preventive Action

Many get confused with corrective and preventive actions.  While corrective action deals with existing nonconformances (defects), preventive actions deal with nonconformities that haven’t occurred, but might occur in the future. 

In section 8.5.3 Preventive Action, ISO 9001 states “The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence.”  Potential problems are usually identified from the analysis of metrics, or from audits.

For example, an organization has a metric for on time delivery, and will take corrective action when delivery falls below 95% on time.  The metric is above the limit, but examination of the metric chart shows that on time delivery has decreased each month for the past 5 months.  A corrective action is inappropriate because the metric hasn’t fallen below the requirement (95%).  In this case, preventive action is more appropriate.

Whereas corrective action requires that action be taken, preventive action does not.  Consider a control chart for a machine tool.  The chart indicates that the tool is wearing and may need to be replaced soon.  Do we change the tool now or wait until the control limit is exceeded?  An economic analysis might suggest that we wait for the control limit to be exceeded because the cost of the tool is high or the cost of lost production is high.   The customer may be in critical need of the product and we can’t afford to shut down the machine now.  A decision to continue production would close the preventive action.

 A decision to take action would allow the machine tool to continue operation while a plan is developed for implementing a replacement.  In contrast, if this were a corrective action, the tool would be shut down until a replacement is available.

Once the decision to take preventive action has been made, the process becomes very similar to corrective action.  An action is selected, usually by a team.  A plan is developed to implement the preventive action selected, and the implemented action is monitored for effectiveness.

Some organizations use one form for both preventive and corrective actions.  In the case of a preventive action, there is no evidence of nonconformance, and there is no containment plan, since a nonconformance has not occurred.  Root cause analysis still occurs because there may be many choices of actions to take.

When the action(s) have been identified, a plan for implementation is developed.

My steps of preventive action look like this:

1.       Problem statement

a.       State the requirement

b.      State the evidence of potential nonconformance

2.       Root cause analysis

3.       Preventive action plan

a.       What action(s) will be taken?  NOTE: The plan might be to do nothing.

b.      When will they be implemented?

4.       Follow Up

a.       Were the actions taken effective?

In contrast, my 5 steps of corrective (See my August 2012 blog) are

1.       Problem Statement

a.       State the requirement

b.      State the nonconformance

c.       State the objective evidence of the nonconformance

2.       Containment Plan

a.       When did the problem start?

b.      What are we doing to control the bleeding while we are looking for a solution ( short term fix)

3.       Root Cause Analysis

4.       Corrective Action Plan

a.       What will be done to eliminate the root cause(s)?

b.      When will they be implemented?

5.       Follow Up

a.       Was the implemented corrective action effective?

b.      Was the short term fix removed?

 

For more information visit www.rosehillsystems.com