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An Auditor’s Best Practices in Issuing a Major Nonconformity

%name An Auditors Best Practices in Issuing a Major Nonconformity

From the opening meeting through the audit and closing meeting, the author describes an auditor’s best practices in issuing a major nonconformity.

As an auditor, one of the most important (and difficult) things to learn is how to issue a nonconformity—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 nonconformity begins. Issuing a nonconformity 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 best practices for an opening meeting. The last five items in this section are critical to preparing the client for potential nonconformities:

  1. Method of reporting audit findings, including grading, if any
  2. 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. System for feedback from the auditee on findings or conclusions of audit
  6. Process for complaints and appeals
Methods of Reporting and Grading Nonconformities

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 nonconformity. 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 nonconformity 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 nonconformity is identified and there is no point in continuing. Termination is highly discouraged, because it is better to know about all minor and major nonconformities right away, 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 communicate 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.

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, nonconformities 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 nonconformity, 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.

%name An Auditors Best Practices in Issuing a Major Nonconformity
Feedback from the Auditee

As an auditor, 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 third-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 against 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 of 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 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 nonconformities as you find them. This is their opportunity to clarify the objective evidence for you and to explain why there is not a nonconformity. Often, at this point in the audit, I will refer to the Standard. I will identify 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 unsure 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 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 nonconformity and what would be a major nonconformity. Usually I can say, “This is definitely not a major nonconformity, because…”

%name An Auditors Best Practices in Issuing a Major Nonconformity

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 nonconformities, but failure to communicate when the closing meeting will be conducted will irritate them further.

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 nonconformity—unless the issue clearly warrants a major nonconformity. 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 nonconformity. 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 requirements, instead of reviewing requirements with the client, and ensuring both parties agree before a finding is issued.

If a finding is major, the auditee should have very few questions. Also, I often find the reason for a major noncconformity is a lack of management commitment to address the root cause of a problem. Issuing a major nonconformity is sometimes necessary to get management’s 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 nonconformity is not a disaster. You just need to create a more urgent plan for action.

Posted in: ISO Auditing

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Auditing: Effective Training in 7 Steps

Effective auditing requires effective training. Our author, who has extensive experience, provides 7 steps to effectively train new auditors.

Recently, a client asked me to create a training course on how to train operators. I could have taught the operators myself, but there were so many people that needed training, that we felt it would be more cost effective to train the trainers.

Usually, I have multiple presentations archived that I can draw upon, but this time I had nothing. I had never trained engineers on how to be trainers before—at least not formally. I thought about what kinds of problems other quality managers have had in training internal auditors, and how I have helped the auditors improve. The one theme I recognized was that most auditors needed feedback.

Deming Cycle

I finally decided to use the Deming Cycle (Plan-Do-Check-Act, (PDCA) as my framework for the training. Most QA Managers are very experienced and have little trouble planning an audit schedule. The next step is to conduct the audit. The problem is that there is very little objective oversight of the auditing process. The ISO 13485 for medical devices Standard requires that “Auditors shall not audit their own work.” Therefore, most companies will opt for one of two solutions for auditing the internal audit process: 1) hire a consultant, or 2) ask the Director of Regulatory Affairs to audit the internal auditing process.

Both of the above strategies meet the requirements of the ISO 13485 for medical devices Standard, but neither strategy helps to improve  internal auditor’s performance. I have interviewed many audit program managers, maybe 50+, and the most common feedback program managers give is “change the wording of this finding” or “you forgot to close this previous finding.” This type of feedback is related to the report writing phase of the audit process. I rarely hear program managers explain how they help auditors improve at the other parts of the process.

When auditors are first being trained, we typically provide examples of best practices for audit preparation, checklists, interviewing techniques AND reports. After the auditors have been “shadowed” by the program manager for an arbitrary three times, the auditors are now miraculously “trained.” Let’s see if I can draw an analogy that will make my point…

That kind of sounds like watching your 16 year-old drive the family car three times and then giving them a license. I guess that’s why my new Ford Festiva was severely dented on all four sides within six months. You may think my father was a Saint, but I think he might have totaled his tenth car by age 18. At least I contained the damage to one vehicle.

Effective Auditing Requires Effective Training For New Auditors: 7 Steps

The key to training auditors to audit is consistent follow-up over a long period of time (1-2 years depending upon the frequency of audits). I recommend following the same training process that accredited auditors must complete. I have adapted that process and developed seven(7) seven specific recommendations:

1. Have a new auditor observe a few audits before they are allowed to participate (make sure they take notes, and explain what you are doing and why, as you conduct audits they are observing)

2. Have new auditors participate as team members for 10-20 audits, before they are allowed to act as a lead auditor

3. Have new lead auditors conduct team audits with another qualified lead auditor for 10-20 audits before you allow them to conduct an audit alone

4. Shadow new auditors for 100% of their first audit and gradually observe less with each subsequent audit; try to plan the shadowing into your audit agenda

5. Review the notes of new auditors periodically throughout the audit to provide suggestions for improvement and identify missing information

6. Have new lead auditors submit a draft audit agenda to you before submitting it to the supplier or department manager

7. Have new lead auditors rehearse their first few opening and closing meetings with you in private before conducting the opening and closing meeting (make sure they have an opening/closing meeting checklist to help them)

The question is…was my training successful?

Well, how much follow-up training of the trainers did the client ask for?

Posted in: ISO Auditing

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