Minimizing nonconformances of received materials and finished goods is a challenge all manufacturers face. Two documents have a role in controlling nonconformances: The Certificate of Compliance and the Certificate of Analysis.
A Certificate of Compliance (or Conformance) is a document your supplier provides which promises that what they sent conforms to the standards set (by you, by the government, by the industry, by themselves, etc.) for that kind of production.
Having these certificates associated with various supply links is one way of sharing the responsibility for quality assurance across the entire supply chain. They are intended to help pinpoint breakdowns and allow a business to deal with issues at the point where they happen, rather than tainting an entire multi-tiered supply chain. Some of the promises made by producers are complex, because they are about more than conformance to physical characteristics. This is one of the things that distinguishes Certificates of Conformance and/or Compliance (COC) from another form of documentation, Certificates of Analysis (COA).
Beyond the statements addressing the quality of physical material flowing down the chain, Certificates of Conformance/Compliance promise that the process itself was done in compliance with certain laws or regulations (safety, environmental, human rights violations such as slavery, human trafficking, and forced or child labor.) Increasingly complex multi-tier supply chains have led to the custom of attaching this documentation at specific points in the external production process. It is a promise with good intentions.
Limitations of Certificates of Compliance (Conformance)
Because of the increase in the numbers of COCs (and COAs) being managed, the sheer volume of them being produced throughout complex, multi-tier supply chains, it can appear that this is the primary function of supply chain QA. Most are filed, and never looked at until there is a crisis.
The best way to illustrate the limitations of the Certificate of Compliance (COC), and why problems are discovered using this document as QA, is to contrast it with a more detailed and certifiable type of documentation, the Certificate of Analysis (COA).
First, the Certificate of Compliance states the accuracy of what it contains. In that sense, it is somewhat like a tax return. The COC proposes that the figures are accurate and can be backed up by receipts. (It should be noted that it doesn’t require presenting those “receipts.”)
Second, in contrast with the COC, the Certificate of Analysis (COA) provides verifiable test results approved by a responsible quality professional.
The difference between the two can be verifiable compliance with specifications per lot versus assuming that materials are in compliance or simply hoping that they are. This can result in nonconformances, as found in the simple definition on a popular reference website.
A non-conformance means that something went wrong – a problem has occurred and needs to be addressed. Non-conformances are addressed with corrective actions. A non-conformance could be identified through customer complaints, internal audits, external audits, incoming material inspection or simply during normal testing and inspection activities. *
Past Tense: Aftermath versus “Beforemath” and defining failure
The critical difference is that the limited Certificate of Conformance may be a reused form that accompanies shipments (i.e., after it is already shipped) or may be a standing form that applies to all shipments, whereas the electronic Certificate of Analysis is submitted for specification compliance approval per lot before something can be shipped. It’s not only a promise, but the test evidence that backs up the promise of compliance. We believe it is the only way to significantly reduce material nonconformances: if the COA is in electronic form and supported with automated analysis.
The issue we can identify in the definition is the tense. Certificates of Conformance are only promises, and there is a high risk of discovering a problem several links down the chain, when a product fails, or causes harm, and when nonconformance reporting proves ineffective.
Isn’t having the customer be the source of information about something having gone wrong a sign of QA failure?
While the definition of “nonconformance” above includes the possibility of “normal testing,” the nature of the document (COC promise of the supplier) doesn’t require it. Is anyone actually checking? And after the problem arises, can a nonconformance report ever undo the damage done in the market place, or even in production?
When the problem is discovered after something is shipped (or in production at the recipient’s facility), it is clearly yet another failure of supply quality management.
Of course, problems discovered when material doesn’t match Certificates of Conformance promises are followed by action, however…
…isn’t a situation that allows things to get that far, requiring actions using hindsight (because flawed materials have already shipped) yet another failure of supply quality management?
The Certificate of Analysis (COA), on the other hand, reflects the result of the physical testing that took place for each lot/batch of material that entered your supply chain. When the physical characteristic of an ingredient or sub-assembly is critical to your product, a COA is very important. It may be the only data in your supply chain providing quality assurance. In a sense, the COA is the actual receipt, per the tax-return example above.
As with the COC, the method used to administer the COA is important.
The question you must ask yourself is “how critical is it for us to quickly stop sub-par material from entering the supply chain”? If your answer is that it is very critical, then the best alternative is to use electronic COAs. These not only provide feedback on each lot, but also give you a chance to prevent the lot from being shipped. In addition, this method of administering COAs allows for Statistical Process Control (SPC), which is impossible with COCs and almost impossible if the method used is document management. With document management, you may have a long enough gap between locating the data and being able to process it so that you can’t prevent a serious problem from cascading through your supply chain or harming the public and your brand reputation.
Again, having the “best” nonconformance management system is reactive, i.e., too little too late.
Managing both Certificate of Compliance (Conformance) and Certificates of Analysis
Without appropriate tools, the windows of time available to intervene close with alarming speed. Traditional tools (paper documents, PDF’s, non-standardized formats) are simply overwhelmed and result in increased risk. The methods of managing vary in the same way.
- The least efficient way of keeping track is by managing COC, COA, NCR paper documents themselves.
- The next level is to manage by tracking scanned copies of those documents using document management systems and email.
- The most efficient and responsive method is to have electronic Certificates which only require access to a laptop within reach of any supplier in your supply chain.
- Then the occasional nonconformance can be managed in the same system as one location for overall supplier quality performance visibility.
With the simplified, no-frills interface provided by GSQA®, the EMNS SaaS supply chain QA system, information is instantly accessible. It is also possible to identify material performance trends, and areas/links of the supply chain that may be problematic.
Far from being bureaucratic paper-pushing, this kind of documentation goes to the heart of the matter. Companies understand that they are, at any given moment, only as good as the promises they make about what they are delivering. Using the most efficient method demonstrates a commitment to meeting or exceeding standards. It demonstrates good citizenship through well-managed compliance with both the letter of the law and its spirit, even when a law is not yet present. It is an expression of fundamental values that the company holds: that it cares about the consumer and is proactive. It doesn’t wait to be forced into doing the right thing. All the above is achievable while saving money and improving the process.
GSQA®, a leader in supplier performance management, offers state-of-the-art tools that restore the ability of your company to proactively manage the flow of material and finished or semi-finished production throughout your supply chain. When used to its fullest capability, the impact of the GSQA® approach reaches beyond operations management, directly into the strategic domain, and to the fundamental relationship your company has built with your customers.