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Archive for the ‘Supplier Qualification’ Category

3 Tools for Qualifying Suppliers

In Forward to MDA, Process Validation, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality, Supplier Survey on January 2, 2013 at 2:59 am

This blog has been moved to the following location and the name has been changed: http://bit.ly/3SupplierTools.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

How to recruit, hire and train an auditor

In Internal Auditing, ISO 19011, Supplier Audit, Supplier Audits, Supplier Qualification, Training on December 24, 2012 at 11:44 pm

Part 3: Training

Passing a webinar on auditing does not make you competent.

Does your company ask incoming inspectors to update CAD drawings when there is a design change? Of course not. Your company has engineers that are trained to use SolidWorks, and it takes a new engineer a while to become proficient with the software. Auditing is a skill that you learn—just like SolidWorks.

My favorite holiday movie…I’ll be watching this later tonight!

I’ve never met a manager that wondered where the value was in having an engineer update a drawing, but many managers view internal and supplier audits as a necessary evil. Instead of asking the expert how few audit days you can get away with, ask the expert: “What is the purpose of auditing?”

The purpose of internal auditing is to confirm that the management system is effective and to identify opportunities for improvement. The purpose of supplier auditing is to confirm that a supplier is capable of meeting your needs and to identify opportunities for improvement. Therefore, if an auditor has no nonconformities and no opportunities for improvement were identified—what a waste of time!

To receive value from auditing, you need auditors that are competent. In clause 6.2.1 of the ISO 13485 Standard it says, “Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.” As the audit program manager, make sure you recruit people that demonstrate auditing competency.

Education

First, educational background is important for auditors. You cannot expect someone who has never taken a microbiology course in their life to be an effective auditor of sterilization validation. Likewise, someone that has never taken a course in electricity and magnetism will not be effective as an auditor for active implantable devices. Therefore, determine what types of processes the auditor will be auditing. Then make sure that the person you hire to be an auditor has the necessary education to understand the processes they will be auditing.

Training

Second, an auditor needs to be trained before they can audit. The auditor needs training in three different aspects: 1) the process they will be auditing, 2) the standard that is the basis for assessing conformity, and 3) auditing techniques. If you are going to be auditing printed circuit board (PCB) manufacturers with surface-mount technology (SMT), then you need to learn about the types of components used to make PCBs and how these components are soldered to a raw board. I know first-hand that anyone can learn how SMT works, but it took me a few months of studying.

If your company is only selling medical devices in the USA, then you will need to learn 21 CFR 820 (i.e. – the QSR). However, if your company also sells devices in Europe in Canada you will need to learn ISO 13485, the MDD (93/42/EEC as modified by 2007/47/EC), and the Canadian Medical Device Regulations (CMDR). I learned about ISO 13485 in a four-and-half day lead auditor course in Florida, I learned about the MDD in a three-day CE Marking Course in Virginia, and I learned about the CMDR in a two-day course taught by Health Canada in Ontario. A 50-minute webinar on each regulation is not sufficient for auditing.

Finally, you need training on the techniques of auditing. A two day course is typically needed. I took a 50-minute webinar and passed a quiz before conducting my first internal audit, but I was not competent.

Skills

Third, an auditor needs specific skills to be effective as an auditor. The most critical skills are: 1) communications skills, 2) organizational skills, and 3) analytic skills. Communications skills must include the ability to read and write exceptionally well and the auditor needs to be able to verbally communicate with auditees during meetings and interviews. The most difficult challenge for auditors is covering all the items in their agenda in the time available. The auditor rarely has more time than the need to audit any topic, and audit team leaders must be able to manage their own time as well as simultaneously managing the time of several other auditors. 

Experience

Last, but certainly not the least important aspect of auditor competency is experience. This is why 3rd party auditors are required to act as team members under the guidance of a more experienced auditor before they are allowed to perform audits on their own. This is required regardless of how many internal or supplier audits the person may have conducted in the past. More experienced auditors are also required to observe new auditors and recommend modifications in their technique. Once a new auditor has completed a sufficient number of audits as a team member, the auditor is then allowed to practice leading audits while being observed. After six to nine months, a new auditor is finally ready to be a lead auditor on their own. An internal auditor does not need the same degree of experience as a 3rd party auditor, but being shadowed 2-3 times is not sufficient experience for an auditor (1st or 2nd party). For more information about this topic, please read my blog posting on auditor shadowing.

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If you are an audit program manager, and you would like to improve your own competency, please contact me to learn about a new advanced course specifically for audit program managers. I am teaching a course with Brigid Glass. The course is designed specifically for audit program managers—not for inexperienced auditors. It will be a two-day course, and we are offering the course in three different cities: San Diego, CA (April 11/12), Orlando, FL (April 15/16) and Las Vegas, NV (April 17/18). Please Contact Me if you would like to learn more about the course.

Click Here

I am also teaching a one-hour, audio seminar with FX Conferences on January 9th:

“Are Your Suppliers Qualified? Prove It.”

This seminar will cover the areas of supplier qualification, supplier evaluation and supplier auditing. We already have a large number of companies signed-up for the seminar, and I am looking forward to having you join us.

This blog started as a single posting, but I realized that the blog was much too long. Therefore, I split the blog into three separate postings. This is the final “Part 3 of 3”. I hope you have enjoyed it. If you have suggestions for my next posting, please let me know.

How to recruit, hire and train an auditor

In Internal Auditing, ISO 19011, Supplier Audit, Supplier Audits, Supplier Qualification on December 24, 2012 at 4:39 am

Part 2: Hiring

Welcome Aboard

If you are an audit program manager that is training a new auditor from another department, treat them like a new hire!

Once you have identified someone that you want to “hire” as an internal auditor, your next step should be to develop an “Onboarding” plan for them with their boss. If you are hiring someone that will be a dedicated auditor, please ignore my quotation marks above. In most companies, however, the internal auditors are volunteers that report to another hiring manager. Therefore, as the audit program manager you need to get a firm commitment from the auditor’s boss with regard to the time required to train the new auditor and to actually perform audits on an on-going basis.

The Trans Siberian Orchestra is a must see–especially if you can take you family to see the performance live.

Winning Over the Boss

In my previous posting I said that, “The biggest reason why you want to be an auditor is that it will make you more valuable to the company.” The auditor’s boss may or may not agree with this statement, but the boss knows that the salary is coming out of their budget either way.

Therefore, talk with the auditor’s boss and find out what the auditor’s strengths and weaknesses are. Find out which skills the boss would like to see the auditor develop. By doing this, the two of you can develop a plan for making the auditor more valuable to their boss AND the company.

Making Re-Introductions

Ideally, auditors are extraverted and they have been with the company long enough to know the processes and process owners that they will be assigned to audit—especially if they will be auditing upstream and downstream from their own process area. In the past the auditor was a customer or a supplier, but now the relationship with a process owner will change. Auditors are required to interview process owners and this involves asking tough questions that might not be appropriate in the auditor’s normal job duties. Therefore, as the audit program manager, you should re-introduce the auditor to the process owner in their new capacity as auditor.

During this re-introduction, it is important to make three points:

  1. the auditor is going to be trained first,
  2. you will be shadowing the auditor during the audit, and
  3. the auditor’s job is to help the process owner identify opportunities for improvement.

By making the first point, you are reminding the process owner of the scheduled audit—well in advance. You are also informing the process owner that this auditor will have new skills, and the process owner should have some tolerance for mistakes that new employees make. You might also mention that you would like to get the process owner’s feedback after the audit so the auditor knows what areas they need to improve to become better auditors.

The second point should put the process owner at ease—assuming the process owner has a good relationship with you as the audit program manager. It is important to be descriptive when “shadowing” is mentioned. Both the process owner and the auditor may not understand the process or the purpose of shadowing. The following blog posting might help with this: “How do you shadow an auditor? Did you learn anything?”

The third point is the most critical step in onboarding a new auditor. For an auditor to be successful, they must ADD VALUE!

As an auditor, you cannot pretend to add value.

The process owner should know their process and they probably know which areas are weakest. The audit program manager should encourage the process owner to list some specific areas in which they are having problems. Ideally, the process owner would be informed of this need prior to the re-introduction. Then the process owner can be better prepared for the meeting, and hopefully they will have a few target areas already identified. Targets with associated metrics are the best choice for a new auditor, because these targets reinforce the process approach to auditing.

Next Steps

Once your new auditor has been re-introduced to the process owners they will be auditing, you need to begin the training process. As with any new employee, it is important to document the training requirements and to assess the auditor’s qualifications against the requirements of an auditor. Every new auditor will need some training, but the training should be tailored specifically to the needs of the auditor.

The training plan for a new auditor should include the following:

  1. a reading list of company procedures specific to auditing and external standards that are relevant;
  2. scheduled dates for the auditor to shadow another experienced auditor;
  3. scheduled dates for an experienced auditor to shadow the auditor during the first two process audits (upstream and downstream);
  4. goals and objectives for the internal audit program; and
  5. any training goals that the auditor’s boss has identified for the auditor.

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If you are an audit program manager, and you would like to improve your own competency, please contact me to learn about a new advanced course specifically for audit program managers. I am teaching a course with Brigid Glass. The course is designed specifically for audit program managers—not for inexperienced auditors. It will be a two-day course, and we are offering the course in three different cities: San Diego, CA (April 11/12), Orlando, FL (April 15/16) and Las Vegas, NV (April 17/18). Please Contact Me if you would like to learn more about the course.

Click Here

I am also teaching a one-hour, audio seminar with FX Conferences on January 9th:

“Are Your Suppliers Qualified? Prove It.”

This seminar will cover the areas of supplier qualification, supplier evaluation and supplier auditing. We already have a large number of companies signed-up for the seminar, and I am looking forward to having you join us.

This blog started as a single posting, but I realized that the blog was much too long. Therefore, I split the blog into three separate postings. This post is “Part 2 of 3”. The final part in the series will be posted tomorrow–December 24, 2012.

How to recruit, hire and train an auditor

In Internal Auditing, ISO 19011, Supplier Audit, Supplier Audits, Supplier Qualification on December 22, 2012 at 7:57 pm

Part 1: Recruiting

Stop begging people to help you audit. Learn how to recruit auditors more effectively.

Stop begging people to help you audit. Learn how to recruit auditors more effectively.

Nearly 100% of the people I train as auditors were not hired specifically to be auditors. Instead, auditing is something extra that they were asked to do in addition to their regular job. This situation creates three problems for the audit program manager:

  1. you have difficulty getting enough people to perform the audits;
  2. most auditors will come from your department, so who is going to audit you; and
  3. the auditors have little or no motivation to get better at auditing.

Stop begging for “volunteers” from other departments and start recruiting.

My favorite holiday song of all time! I sing this to myself in car rides during July.

When I am recruiting someone to audit, I always get asked two questions:

  1. Who/What will I be auditing?
  2. What will I have to do?

You need to motivate people to become auditors, because it requires extra work. The answer to #2 should be specific. I recommend creating a “sell sheet” that explains the process of performing an audit. I also like to create sell sheets that are educational. Therefore, I recommend adapting the flow chart in ISO 19011:2011 (Figure 2 on page 15). I would add time estimates for each step of the process (6.2 – 6.7). This will serve as a training tool for future auditors, and it will eliminate the fear of unknown time commitment for your potential recruit.

In order to answer #1, I recommend you assign the recruit processes that are upstream and downstream. I have recommended this concept in previous postings, but essentially you are assigning the person to audits of internal suppliers and internal customers. By doing this, utilizing the process approach will be more natural to the auditor and they will have a vested interest in doing a thorough audit. This also creates a situation where the auditor is typically assigned to at least two process audits per year.

The next question is one that your potential recruit will never ask, but they are always thinking it…

Why should I become an auditor?

The biggest reason why you want to be an auditor is that it will make you more valuable to the company.

Auditors are required to interview department managers and ask tough questions. This gives the auditor a better understanding of the organization as a whole, and it gives them insight into how other managers work. This insight is pure gold.

If you want to be effective and get promoted, you need to demonstrate value to your boss and top management. If you don’t understand what other departments need, how can you help them? No manager will promote a selfish, power-hungry hog. They promote team players that make others better. Auditing gives you the insight necessary to understand how you can do that.

Auditing other departments will also give you insider information as to where new job openings will be. Sometimes you can’t wait for your boss to get promoted. In that case, you might want to know more about other departments in your company.

Each corporate culture is different, but the audit program manager needs to “sell” the recruit on volunteering to be an auditor.

Where to find recruits

Due to the cross-functional nature of auditing, I have found that my own personal experience working in multiple departments was invaluable. I have a better understanding of how a department functions than other auditors, because I have worked in that department at another company. Operations, engineering and research experience are extremely valuable for auditing, but I think the experience that transfers the best to auditing is service.

If your company is large enough to hire full-time auditors, I recommend searching for potential auditors at your suppliers and their competitors. These people will bring unique knowledge that is critical to a successful supplier selection process, and these individuals will increase the diversity in your company—instead of duplicating knowledge and expertise.

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This blog started as a single posting intended to help a Compliance Manager in the Twin Cities. Unfortunately, I ran out of time to finish the blog and it has been a couple of weeks since my last post. When I restarted the blog this weekend, I realized that the blog was much too long. Therefore, this is part 1 of 3. Part 2 will be about hiring auditors, and part 3 will be about training auditors.

For those of you that want to learn more, I am teaching a course with Brigid Glass in April. The course is designed specifically for audit program managers—not for inexperienced auditors. It will be a two-day course, and we are offering the course in three different cities: San Diego, CA (April 11/12), Orlando, FL (April 15/16) and Las Vegas, NV (April 17/18). Please Contact Me if you would like to learn more about the course.

Click Here

I am also teaching a one-hour, audio seminar with FX Conferences on January 9th:

“Are Your Suppliers Qualified? Prove It.”

This seminar will cover the areas of supplier qualification, supplier evaluation and supplier auditing. We already have a large number of companies signed-up for the seminar, and I am looking forward to having you join us.

The Supplier Audit Agenda

In Audit Schedule, Contract Manufacturers, Forward to MDA, ISO, ISO 13485, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality on April 21, 2012 at 12:24 pm

This blog has been moved to the following location and the title has been changed: http://bit.ly/SupplierAuditAgenda.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

Supplier Survey with a Twist

In Forward to MDA, Supplier Qualification, Supplier Quality, Supplier Survey on March 29, 2012 at 4:35 am

This blog has been moved to the following location: http://bit.ly/SupplierSurvey.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

Which Suppliers Should You Audit?

In Audit Schedule, Contract Manufacturers, Forward to MDA, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality on March 26, 2012 at 4:55 am

This blog has been moved to the following location, and the title has been changed: http://bit.ly/WhichSuppliers.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

Why did you Qualify that Supplier?

In Forward to MDA, Supplier Qualification, Supplier Quality on March 20, 2012 at 3:13 am

This blog has been moved to the following location, and the title has been changed: http://bit.ly/WhythatSupplier.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

How do you qualify a supplier that doesn’t have a Quality Management System?

In Forward to MDA, ISO 13485, Procedures, Purchasing, Quality Management Systems, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality, Supplier Survey on March 9, 2012 at 12:11 pm

This blog has been moved to the following location, and the title has been changed: http://bit.ly/NoQMSupplier.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

Who Does Supplier Audits in Your Company?

In Forward to MDA, Purchasing, Supplier Audit, Supplier Audits, Supplier Qualification, Supplier Quality on March 2, 2012 at 6:26 am

This blog has been moved to the following location, and the title has been changed: http://bit.ly/Whodoesaudits.

This blog website and the blogs within it are gradually being transferred over to my new website: http://www.MedicalDeviceAcademy.com. The titles may change, and there may be minor revisions to the content as the blogs are reviewed and edited. There will be a subscription list created for the new blog site. If you would like to be added to the list for the new blog site, please email me directly at: rob@13485cert.com.

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