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Steven Stein

Quality Insider

Dealing With Supplier Nonconformances

Persistence pays for Brookhaven National Lab

Published: Wednesday, June 10, 2015 - 15:14

Supply chain quality is a hot topic these days. Suppliers may be considered third-party organizations, but they are also extensions of your organization. One aspect of managing supplier quality is dealing with shipments of nonconforming items, parts, or services from suppliers.

The following are two typical paths that an organization can take to deal with a supplier nonconformance:
1. Only request that the supplier only replace or repair the items or redo the service
2. Request the supplier to complete one of the following:
• A supplier corrective action request(SCAT)
• A corrective action plan (CAP), also referred to as corrective and preventive action (CAPA)1

A SCAR or CAP has the following basic elements:
1. Provides a description of the nonconformance
2. Supplier conducts a causal analysis to determine apparent or root cause(s).2 A graded approach can be used, based the risks of the nonconformance, to determine which type of cause is needed, i.e., either apparent or root.
3. Supplier determines actions (both corrective and preventive) to address the cause(s)
4. Supplier assigns action owner(s) and proposed due date(s) when the actions are to be implemented

If the answer is yes to one or more of the following conditions, then a SCAR or CAP needs to be issued:
• A specific important nonconformance, e.g., the nonconformance involves significant risk
• An unsatisfactory quality history
• A repeat nonconformance
• There is a significant risk, e.g., loss of a customer, harm to the environment, impact to personal safety, or health, regulatory violations

It can be difficult to get your suppliers to address a SCAR or CAP. Although the following case study isn’t meant to be a model of a supplier corrective action plan, we’ll examine how one supplier was issued with a SCAR and how it was handled.

Background

Brookhaven National Lab ships waste for disposal to approved waste disposal sites. Per the U.S. Department of Transportation (DOT) regulations, these shipments must be properly placarded, i.e., show what type of hazardous material a vehicle is transporting.

Specifically, the DOT’s 49 CFR—Pipeline and Hazardous Materials Safety Administration (PHMSA), requires that a placard meets the following requirements:
• Background color on the placard must be white in the lower portion with a striped upper portion.
• Base of the striped portion must be 29 mm ±5 mm (1.1 in. ±0.2 in.) above the placard horizontal center line.

A correct placard looks like this:


Figure 1: Correct PHMSA placard

However, we received the following nonconforming placard from our supplier:


Figure 2: Incorrect PMHSA placard. The base of the striped portion is right at the placard’s horizontal center line instead of being 29 mm ±5 mm (1.1 in. ±0.2 in.) above it.

Reporting the nonconformance to the supplier

It seemed apparent that there were a number of opportunities in the supplier’s process where this nonconformance should have been detected by either manufacturing or quality assurance staff. One of the goals in supply chain quality is to report nonconformances to suppliers so they can take actions to improve the quality of their items or services. It was decided that a SCAR would be issued because using these placards would put us a risk with not meeting DOT regulatory requirements.

When I contacted the company, the customer service staff didn’t think their company could have manufactured their placard that way. However, they would replace it. They didn’t understand that they needed to take action on this nonconformance. I made a second call and was again unsuccessful in getting them to understand the significance of the nonconformance. I went to the company’s website and found a page that allowed me to send a message directly to the company’s president. Within an hour after sending the message, I was contacted by a vice president. This person immediately understood the significance of the nonconformance. I informed him that the company would receive a SCAR along with instructions on how to complete it.

Supplier’s response

After an investigation, the supplier found that the nonconformance occurred because the placards were printed using the striped flood plate intended for international placards rather than for the placards required by the DOT. The correct striped flood plate had not been used.

Apparent causes for problem
• Pre-production: Flood plates are not provided for each job but are used communally based on need (i.e., one flood plate is used for multiple products)
• Post-production: Quality assurance (QA) inspection had production art that was insufficient for proper inspection
Note: This wasn’t a critical supplier, and therefore the decision to either determine only apparent causes wasn’t questioned.

Corrective actions that would be instituted:
• A set of known, correct samples would be provided to post-production QA (i.e., actual samples and an additional poster or chart for reference).
• Flood plates would be marked to identify them by product part number(s), stamp, and file.
• Art would be modified by part number(s) to reflect required text, graphics, and flood plates needed to produce it.
• Employees would be in these revised procedures.
• The process would be audited after three months and again in six months to determine compliance.

Conclusion

As we see in this example, initial attempts to get the supplier to respond appropriately to a nonconformance (SCAR) might not succeed. It is recommended that the request be made to someone higher up in the management chain, in this case taking advantage of communicate access to the president. The company did find problems in its processes that it was unaware of. By conducting a causal analysis and then taking the appropriate actions, the company’s quality will be improved. This will benefit us and other customers, and save time and money by not having to deal with nonconforming items or services.

Points to ponder
In my experience, suppliers struggle to perform a true root cause analysis. If they can at least determine apparent cause(s), that might be sufficient. It is a judgment call to determine if suppliers’ causal analyses are sufficient. Also, consider assisting (i.e., partnering) them in their casual analysis by providing guidance on various causal analysis methodologies, such as 5 Whys and barrier analysis.

There is a hierarchy of actions that also should be considered when evaluating the proposed actions.3 About 80 percent of time, in my experience, suppliers will choose to take the least effective action of either training employees or revising a procedure. Check with the supplier to see if it can take the other types of action to address the cause, for example, using engineering controls.

References
1. ISO 9000 defines these terms as:
Corrective action: Take action to eliminate the causes of nonconformances in order to prevent recurrence
Preventive action: Determine action(s) to eliminate the causes of potential nonconformances in order to prevent their occurrence

2. Apparent cause:
The most probable cause for an event based on readily available information.
A logical conclusion of cause based upon readily available facts established during a limited investigation.
• A cause derived with a minimum investigation of the condition or event.

3. Hierarchy of actions:


Discuss

About The Author

Steven Stein’s picture

Steven Stein

Steve Stein has more than 40 years as a quality professional and has worked in the medical device and R&D environments. He has been involved in analyzing business and quality systems through external/internal assessments and evaluating supply chain management programs. He was a Certified Quality Engineer (CQE) and a Certified Quality Auditor (CQA) by the American Society for Quality for more than 30 years.

Comments

Whether you are dealing with

Whether you are dealing with a new supplier or a supplier you’ve had a long-term relationship with, there can be issues on non-conformance. This can happen for a number of reasons including staying competitive, time issues, and lower costs. Issues of non conformance can lead to increased long-term costs, prolonged production or delays, and sacrificing relationships with customers and market standards.