13485cert

How to Issue a Major Non-Conformity with a Smile

In Internal Auditing on March 18, 2013 at 5:37 pm

audit_smile_announcement

As an auditor, one of the most important (and difficult) things for you to learn is how to issue a non-conformity—especially a major. This is normally done at the closing meeting of an audit, but the closing meeting is not where the process of issuing the non-conformity begins. Issuing a non-conformity actually starts in the opening meeting.

ISO 19011:2011 is the official guidance document for auditors of Quality Management Systems. Section 6.4.2 of this Standard explains the best practices for an opening meeting. The last five items in this section are critical to preparing the client for potential non-conformities:

  1. the method of reporting audit findings including grading, if any;
  2. the conditions under which the audit may be terminated;
  3. time and place of the closing meeting;
  4. how to deal with possible findings during the audit;
  5. the system for feedback from the auditee on the findings or conclusions of the audit,
  6. the process for complaints and appeals.

Methods of Reporting and Grading

The auditor should be crystal clear in their description of minor and major nonconformities or any other grading that will be used. The auditor should also make it clear that they are looking for conformity rather than non-conformity. This is an audit—not an inspection. Typically, a minor nonconformity is described as “a single lapse in the fulfillment of a requirement” while a major nonconformity is described as one of the following: 1) “a total absence in the fulfillment of a requirement,” 2) “repetition of a previous nonconformity,” 3) “failure to address a previously identified minor non-conformity”, or 4) “shipment of non-conforming product.” When the auditor is in doubt, then the finding is minor and never a major. For a major non-conformity to be issued there can be no doubt.

Conditions for Termination

The option to terminate an audit is typically reserved for a certification audit where a major non-conformity is identified and there is no point in continuing. Termination is highly discouraged, because it is better to know about all the minor and major non-conformities now instead of waiting until the certification audit is rescheduled. The certification body will charge you for their time anyway.

Another reason for termination is when an auditor is being unreasonable or inappropriate. This is rare, but it happens. If the audit is terminated you should always being communicating this to upper management at the certification body and the company—regardless of which side of the table you sit. For FDA inspections this is not an option. For audits performed by Notified Bodies, there is the possibility of suspension of a certificate in response to audit termination. Therefore, I always recommend appealing after the fact instead of termination. Appealing also works for FDA inspections.

Closing Meeting

The closing meeting should be conducted as scheduled and the time/location should be clearly communicated to upper management in the audit agenda and during the opening meeting. Top management won’t be happy about non-conformities, but failure to communicate when the closing meeting will be conducted will irritate them further.

How to Deal with Findings

All guides and auditees should be made aware of possible findings at the time an issue is discovered. This is important so that an auditee has the opportunity to clarify the evidence being presented. Often non-conformities are the result of miscommunication between the auditor and auditee. This happens frequently when the auditor has a poor understanding of the process being audited. It is a tremendous waste of time for both sides when this occurs. If there is an actual non-conformity, it is also important to gather as much objective evidence as possible for the auditor to write a thorough finding and for the auditee to prepare an appropriate corrective action plan in response to the finding.

feedbackFeedback from the Auditee

I always encourage auditees to provide honest feedback to me directly and to management so that I could continue to improve. If you are giving feedback about an internal auditor or a supplier auditor, you should always give feedback directly before going to the person’s superior. You are both likely to work together in the future, and you should give the person every opportunity to hear the feedback first-hand.

When providing feedback from a 3rd party Certification Audit, you should know that there will be no negative repercussions against your company if you complain directly to the Certification Body. At most, the Certification Body will assign a new auditor for future audits and investigate the need for taking action with the auditor. In all likelihood, any action taken will be “retraining.” I never fired somebody for a single incident—unless they broke the law or did something that was unsafe. The key to providing feedback, however, is to be objective. Give specific examples in your complaint, and avoid personal feelings and opinions.

Complaints and Appeals

As the auditee, you should ask for the contact information at the certification body during the opening meeting. Ask with a smile—just-in-case you disagree and so you can provide feedback (which might be positive). As the auditor, you should always make the contact information for the certification body available. If you are conducting a supplier audit or an internal audit, you probably know the auditor’s boss and there is probably no formal complaint or appeals process. In the case of a supplier audit, the customer is always right—even when they are wrong.

During the Audit

During the audit you should always make the guide(s) and process owner(s) aware of any potential non-conformities as you find them. This is their opportunity to clarify the objective evidence for you and to explain why there is not a non-conformity. Often I will refer to the Standard that I am auditing to at this point. I will identify the specific requirement(s) and show the process owner. I will say, “This is what I am trying to verify. Do you have anything that would help address this requirement?” If the process owner is not sure of how to meet the requirement, often I will provide an example of how this requirement is addressed in other areas or at other companies.

If the audit is a multi-day audit, I will review the potential nonconformities at the end of the day and give the auditee the opportunity to provide additional objective evidence in the morning. If it is already the last day of the audit or it is a single-day audit, I will give auditees until the closing meeting to provide the objective evidence. Often I will use this opportunity to explain what would be considered a minor non-conformity and what would be a major non-conformity. Usually I can say, “This is definitely not a major non-conformity, because…”

closingClosing Meeting

At the closing meeting, the auditee should never be surprised. If an issue remains unfulfilled at the closing meeting, the auditee should be expecting a minor non-conformity—unless the issue clearly warrants a major non-conformity. Since a minor nonconformity is described as “a single lapse in the fulfillment of a requirement,” it is difficult for an auditee to argue that an issue does not warrant a minor non-conformity. Typically, the argument is that you are not consistent with other auditors. The most common response to that issue is, “Audits are just a sample, and previous auditors may not have seen the same objective evidence.” The more likely scenario, however, is that the previous auditor interprets the requirements instead of reviewing the requirements with the client and making sure both parties agree before a finding is issued.

A major nonconformity is usually defined as one of the following: 1) “a total absence in the fulfillment of a requirement,” 2) “repetition of a previous nonconformity,” 3) “failure to address a previously identified minor non-conformity”, or 4) “shipment of non-conforming product.” When the auditor is in doubt, then the finding is minor and never a major. For a major non-conformity to be issued there can be no doubt. If a finding is major, the auditee should have very few questions. Also, I find that often the reason for a major non-conformity is a lack of management commitment to address the root cause of a problem. Issuing a major non-conformity is sometimes necessary to get management attention.

Regardless of the grading, all audit findings will require a corrective action plan—even an FDA warning letter requires a CAPA plan. Therefore, a major non-conformity is not a disaster. You just need to create a more urgent plan for action.

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: