Attention Auditors! – Have you read ISO 19011?

If you have ever taken a lead auditor course, one of the critical handouts for the class should have been ISO 19011. The title is “Guidelines for Auditing Management Systems”. In November of last year, this standard was updated and the changes were not superficial.

The background entertainment for this week is one of my favorite modern rock songs, but it never seemed to get much air time. I hope you enjoyed the 90’s.

ISO 19011 covers the topic of quality management system auditing. This Standard provides guidance on managing audit programs, conducting both internal and external audits, and how to determine auditor competency. Improvements to the New 2011 Version of the Standard include:

1. Broadening the scope to all management systems
2. Clarifying the relationship between ISO 17021 and ISO 19011
3. Introduction of the remote audit methods
4. Introduction of risk as an auditing concept
5. Confidentiality is a “new” principle
6. Clause 5, Managing an audit program, was reorganized
7. Clause 6, Performing an audit, was reorganized
8. Clause 7, Competence and evaluation of auditors, was reorganized & strengthened
9. Annex B is new and the contents of the help boxes was moved to this Annex
10. Annex A now includes examples of discipline-specific knowledge and skills

One of the most common points of confusion in the lead auditor course is the difference between 1^st, 2^nd and 3^rd party audits. In the previous revision of this Standard, this was just a note at the bottom of page 1 and the top of page two. The note was not very clear either. The new version of 19011, in Table 1 (reproduced below), the difference between these three types of auditing is crystal clear:

The above table is just an example of the improvements made to ISO 19011, and of course there is little value-add to clarifying a definition. Figure 1 from the new version, “Process flow for the management of an audit program, is a better example of a “value-add”. This vertical flow chart is reminiscent of Figure 1 from ISO 14971:2007. It categorizes the various stages of audit program management into the Plan-Do-Check-Act (PDCA) cycle. I highly recommend this style for presenting any process in your internal procedures as an example of best practices in writing an SOP. The flow chart even references each of the clauses in the Standard. Unfortunately Figure 2, “Typical audit activities”, does not categorize the stages of audit activities (Clauses 6.2 – 6.7 of the revised Standard) into the PDCA cycle. I guess they needed to leave some improvement for the next revision.

The new version retained the opening meeting checklist that was in the previous revision (Clause 6.4.2), and Clause 6.4.9 has a brief closing meeting checklist. Figure 3, “Overview of the process of collecting and verifying information”, is a poor example of a flow chart. Should I make a better one? (Send me an email if you think I should.)

The most valuable changes in this revision are Clause 5.3.2, “Competence of the person managing the audit program”, and all of Clause 7. Most of the audit procedures I read neglect to define the qualifications and method for determining competency of the audit program manager. Clause 5.3.2 tells you how. Put it in your own procedure. Most of the procedures I read include qualifications for a “Lead Auditor”, but I seldom see anything regarding competency. Unfortunately, this Standard only specifically addresses “Lead Auditor” competency in a two-sentence paragraph—Clause 7.2.5. When I teach people how to be a lead auditor, I spend more than an hour on this topic alone.

The Standard would be more effective by providing an example of how 3^rd party auditors become qualified as a Lead Auditor. 3^rd party accreditation requires the auditor to be an “acting lead” for audit preparation, opening meeting, conducting the audit, closing meeting, and final preparation/distribution of the audit report. This must be performed for 15 certification audits (i.e. – Stage 2 certification or recertification), and another qualified lead auditor must evaluate you and provide feedback.

The last big additions to this Standard were the Appendices. Annex A provides examples of discipline-specific knowledge and skills of auditors. This section is a little on the boring side. I prefer to tell a story about the internal auditor that was auditing incoming inspection—but they had no idea how to check for calibration or how to measure components. Appendix B, the finale, has a table (Table B.1) that provides some guidance on how to conduct remote audits (i.e. – desktop audits). I was pleased to see that conducting interviews is a major part of remote auditing in this table. Section B.7 provides some suggestions with regard to conducting interviews, but if you exhibit all 13 of the professional behavior traits found in Clause 7.2.2 then you really don’t need any advice on how to speak with people. For the rest of us mortals, we could use a five day course on interviewing alone.

Additional guidelines are available on the ISO website.

Advertisement

How to Train an Auditor on the Process Approach

Country music fans are loyal blog readers too.

            I have been reviewing the trends for how people find my website, and a large number of you appear to be very interested in my auditing schedules and other audit-related topics. Therefore, this week’s blog is dedicated to training auditors on the process approach.

First, the process approach is just a different way of organizing audits. Instead of auditing by clause, or by procedure, instead you audit each process. Typical processes include:

1. Design & Development
2. Purchasing
3. Incoming inspection
4. Assembly
5. Final Inspection
6. Packaging
7. Sterilization
8. Customer Service
9. Shipping
10. Management Review
11. CAPA
12. Internal Auditing

There are two reasons why the process approach is recommended. First, the process approach identifies linkages between processes as inputs and outputs. Therefore, if there is a problem with communication between departments the process approach will catch it. If only a procedural audit is performed, the lack of communication to the next process is often overlooked. Second, the process approach is a more efficient way to cover all the clauses of the ISO Standard than auditing each clause (i.e. – the element approach).

My rationale for the claim of greater efficiency is simple: there are 19 required procedures in the ISO 13485 Standard, but there are only 12 processes identified above. The “missing” procedures are actually incorporated into each process audit. For example, each process audit requires a review of records as input and outputs. In addition, training records should be sampled for each employee interviewed during an audit. Finally, nonconforming materials can be identified and sampled at incoming inspection, in assembly processes, during final inspection, during packaging, and even during shipment.

The tool that BSI uses to teach the process approach is the “Turtle Diagram”. The following picture illustrates where the name came from.

Process Auditing – “Turtle Diagram”

The first skill to teach a new auditor is the interview. Each process audit should begin with an interview of the process owner. The process owner and the name of the process are typically documented in the center of the turtle diagram. Next most auditors will ask, “Do you have a procedure for ‘x process’?” This is a weak auditing technique, because it is an “closed-ended” or yes/no. This type of question does little to help the auditor gather objective evidence. Therefore I prefer to start with the question, “Could you please describe the process?” This should give you a general overview of the process if you are unfamiliar with it.

After getting a general overview of the process, I like to ask the question: “How do you know how to start the process.” For example, inspectors know that there is material for incoming inspection, because raw materials are in the quarantine area. I have seen visual systems, electronic and paper-based systems for notifying QC inspectors of product to inspect. If there is a record indicating that material needs to be inspected—that is the ideal scenario. A follow-up question is, “What are the outputs of the inspection process?” Once again, the auditor should be looking for paperwork. Sampling these records and other supporting records is how the process approach addresses Clause 4.2.4—control of records.

The next step of the process approach is to “determine what resources are used by incoming inspection.” This includes gages used for measurement, cleanliness of the work environment, etc. This portion of the process approach is where an auditor can review calibration, gowning procedures, and software validation. After “With What Resources,” the auditor then needs to identify all the incoming inspectors on all shifts. From this list the auditor should select people to interview and follow-up with a request for training records.

The sixth step of the process is to request procedures and forms. Many auditors believe that they need to read the procedure. However, if a company has long procedures this could potentially waste valuable time. Instead, I like to ask the inspector to show me where I can find various regulatory requirements in the procedures. This approach has the added benefit of forcing the inspector to demonstrate they are trained in the procedures—a more effective assessment of competency than reviewing a training record.

The seventh and final step of the turtle diagram seems to challenge process owners the most. This is where the auditor should be looking for department Quality Objectives and assessing if the department objectives are linked with company Quality Objectives. Manufacturing often measures first pass yield and reject rates, but every process can be measured. If the process owner doesn’t measure performance, how does the process owner know that all the required work is getting done? The seventh step also is where the auditor can sample and review monitoring and measurement of processes, and the trend analysis can be verified to be an input into the CAPA process.

In my brief description of the process approach I used the incoming inspection process. I typically choose this process for training new auditors, because it is a process that is quite similar in almost every company and it is easy to understand. More importantly, however, the incoming inspection process does a great job of covering more clauses of the Standard than most audits. Therefore, new auditors get a great appreciation for how almost all the clauses can be addressed in one process audit.

If you have questions, or you would like a copy of the turtle diagram I use for documentation of audits, please submit a request on my website contact us page.

The Ultimate Design Control SOP

Disclaimer: There is no need to create the Ultimate Design Control SOP. We need medical devices that are safer and more effective.

If Adele is worthy of six Grammy Awards, she’s probably worthy of a blog link too. Rumor has it that this is my personal favorite from Adele.

In my previous blog posting, I indicated six things that medical device companies can do to improve design controls. While the last posting focused on better design team leaders (WANTED: Design Team Needs Über-Leader), this posting focuses on writing stronger procedures. I shared some of my thoughts on writing design control procedures just a few weeks ago, but my polls and LinkedIn Group discussions generated great feedback regarding design control procedures.

One of the people that responded to my poll commented that there was no option in the poll for “zero”. Design controls do not typically apply to contract manufacturers. These companies make what other companies design. Therefore, their Quality Manual will indicate that Clause 7.3 of the ISO 13485 Standard is excluded. If this describes your company, sit back and enjoy the music.

Another popular vote was “one”. If you only have one procedure for design controls, this meets the requirements. It might even be quite effective.

When I followed up to poll respondents asking how many pages their procedures were, a few people suggested “one page”. These people are subscribing to the concept of using flow charts instead of text to define the design control process. In fact, I use the following diagram to describe the design process all the time: The Waterfall Diagram!

From the US FDA Website.

I first saw this in the first AAMI course I took on Design Controls. This is on the FDA website somewhere too. To make this diagram effective as a procedure, we might need to include some references, such as: work instructions, forms, the US FDA guidance document for Design Controls, and Clause 7.3 of the ISO Standard.

The bulk of the remaining respondents indicated that their company has eight or more procedures related to design controls. If each of these procedures is short and specific to a single step in the Waterfall Diagram, this type of documentation structure works well. Unfortunately, many of these procedures are a bit longer.

If your company designs software, active implantable devices, or a variety of device types—it may be necessary to have more than one procedure just to address these more complex design challenges. If your company has eight lengthy procedures to design Class 1 devices that are all in the same device family, then the design process could lose some fat.

In a perfect world everyone on the design team would be well-trained and experienced. Unfortunately, we all have to learn somehow. Therefore, to improve the effectiveness of the team we create design procedures for the team to follow. As an auditor and consultant I have reviewed 100+ design control processes. One observation is that longer procedures are not followed consistently. Therefore, keep it short. Another observed I have made is that well-design forms help teams with compliance.

Therefore, if you want to rewrite your design control SOP try the following steps:

1. Use a flow chart or diagram to illustrate the overall process
2. Keep work instructions and procedures short
3. Spend more time revising and updating forms instead of procedures
4. Train the entire team on design controls and risk management
5. Monitor and measure team effectiveness and implement correct actions when needed

The following is a link to the guidance document on design controls from the US FDA website.

Refer to my LinkedIn polls and discussions for more ideas about design control procedures:

1. Medical Devices Group
2. Elsmar Cove Quality Forum Members Group

In addition to the comments I made in this blog, please refer back to my earlier blog on how to write a procedure.