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21 CFR 820.80: 3 Ways to Record Inspection Results

6 inch caliper 21 CFR 820.80: 3 Ways to Record Inspection Results This blog reviews the FDA requirements within 21 CFR 820.80 for recording acceptance of product, including three suggestions for streamlined, value-added inspection. 

If you are inspecting a lot of material at incoming inspection, and the inspection plan calls for inspecting 10 samples for length, what is the best way to record the results?

The person that sent me this question also provided three options (read on for better suggestions from Medical Device Academy):

  1. Record the maximum and minimum dimensions
  2. Record all 10 measurements in a data collection table
  3. Circle “pass” or “fail” next to each sample number

21 CFR 820.80 Requirements

The first method fails to meet the requirement as specified in 21 CFR 820.80(b) (http://bit.ly/21CFR820-80), because recording only the maximum and minimum dimensions of the ten samples does not include the inspection results for the eight samples in between the extremes. The second method meet the requirements, but this method takes the most amount of time. The third method appears to meet the requirements. However, if you read the FDA requirements more carefully, 21 CFR 802.80(e)(3) states that “[Inspection] records shall include…the results.” If the test method is pass/fail, circling pass or fail makes sense, but if the test is a measurement of a dimension, then the result should be a measurement. In addition, if you have to perform an investigation for a complaint or nonconforming product, then this dimensional information might be critical to the analysis.

The FDA has provided an official interpretation of these requirement in the preamble: http://bit.ly/QSR-preamble. “Comment # 147: One comment stated that recordkeeping is a significant cost factor in the operation of a total quality system, and that the revised CGMP regulation should not add cost through duplication of documentation. The comment said recording all quantitative data is inappropriate and of little value.

FDA agrees that unnecessary duplication of documentation should be avoided. They also believe that the Quality System Regulation requires the minimum documentation necessary to ensure that safe and effective devices are designed and produced. FDA similarly believes that maintaining records of results of acceptance activities is imperative to ensure that nonconforming product is not inadvertently used or distributed. FDA has, however, deleted from Sec. 820.80(a) the requirement for recording the results of inspections and testing, because Sec. 820.80(e) requires that the results of acceptance activities be recorded. The requirement in Sec. 820.80(a) was therefore unnecessary. Further, the regulation does not specify quantitative data, but simply requires that the results be recorded.

The FDA believes that it is essential for the manufacturer to maintain records which provide evidence that required acceptance activities were completed. These records must clearly show whether the product has passed or failed the acceptance activities according to the defined acceptance criteria. If product fails to pass acceptance activities, you must identify the product as nonconforming product and conduct an investigation. If the acceptance records are not clear about how the product failed, then the manufacturer may end up duplicating the acceptance to perform appropriate investigations.

Here are three other methods that can save you time and add value.

Method 1: Run Charts

If you create an inspection form that is in the form of a “Run Chart,” then you can put an “X” on the appropriate location of the Run Chart for each sample (see Chart 1 Below). It is less time consuming to write an “X” than the actual value. However, if you need to conduct an investigation, you can convert the “X” into a quantitative number and enter the values into a spreadsheet or statistical analysis software (e.g., Minitab). In addition, inspectors and supervisors can visually glance at a Run Chart and determine if the measurement is “in control” or “out of control.” This is done by marking the upper and lower specifications on the Run Chart. Over time, alert limits can be established as a preventive action, as well. You can also use this data as a rationale for eliminating certain inspections, reducing sampling, qualifying suppliers and even converting a part from statistical sampling to a “dock-to-stock” inspection.

Chart 1 for Inspection Blog 21 CFR 820.80: 3 Ways to Record Inspection Results

One disadvantage of Method 1 is that it takes time to create inspection forms, and the forms need to be maintained as a controlled document, with the drawings for each part–as paper records or electronically. Therefore, I recommend that companies create a quality plan that calls for creating one of these charts every time an NCR is initiated for a part. That way you only are creating this type of chart for parts that are found to be out of specification. This approach allows you to implement the work over a reasonable period of time.  You can also get into the habit of automatically reviewing historical data when you have an NCR that does not already have a Run Chart created.

Method 2: Automation

If you have critical inspection activities and a high volume of parts to inspect, you may want to automate the process of recording measurements and performing data analysis. This can be done by purchasing digital inspection devices with the ability to automatically send the values to a computer system. Devices with this capability only require pressing a button to record the value, and the computer system will often provide the inspector with the sampling plan for each lot automatically. These are sophisticated software systems that require validation, but this provides manufacturers with extensive real-time data on supplier performance, in-process inspection and final acceptance of product. The primary disadvantage of this method is cost of installation and set-up.

Method 3: Pass/Fail with Go/No-Go Gauges

If a supplier is capable of making good parts with a high-degree of certainty, you may have no need for routine monitoring of part dimensions. In this case you can reduce your inspection time by using a “go/no-go” gauge for critical attributes instead of measuring the dimensions. This type of gauge would be ideal if the tolerance for a part with a tolerance of +/- 3 mm. The length of a part can be verified to be between two lines, representing the upper and lower specification for the tolerance. This method can also be used for precise tolerance if magnification is used, but it is recommended to perform a gauge R&R study of any go/no-go gauge for parts with known dimensions (both conforming and nonconforming product). If this type of inspection is used, you can use an inspection record that only records pass/fail. This inspection method is not recommended, however, for parts that occasionally are out of conformity, because re-measurement of parts will be necessary as part of the investigation of nonconforming product.

Statistical Techniques

The biggest advantage of method 1 and method 2 is that they facilitate conducting statistical analysis of data. Chart 1 shows that there is too much variation for the tolerance of 6.50 mm to 6.60 mm. Some companies qualify suppliers for a new part by establishing a threshold for a minimum Cpk value (i.e., process capability coefficient). A typical Cpk minimum is 1.33. Often the company will require that the supplier provide the data for 100% inspection of the initial production lot. This data is then used to create a sampling plan based upon the likelihood of parts being out-of-specification. High risk dimensions might require 99.5% confidence, medium risk dimensions might require 99% confidence and lower risk dimensions might require 95% confidence. Each confidence level corresponds to a different Cpk value. It is not possible to do this type of analysis for Method 3.

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3 Tools for Effectively Qualifying Suppliers

%name 3 Tools for Effectively Qualifying Suppliers

Do you have the right tools for qualifying your suppliers?


For every task you have a choice of tools that you can use. For qualifying your suppliers, are you using the correct tools? 

This blog reviews how to utilize statistical process control, process validation and supplier auditing to effectively qualify suppliers.
If you could afford to audition suppliers for a few months against hundreds of other competitors, then only the qualified suppliers would be approved. Unfortunately, you don’t have the same budget that American Idol has. So what should you do instead?

Most companies use the same three, tired tools to qualify suppliers: ISO Certification, Quality Manuals and questionnaires. ISO certification is a weak tool, because certification is only as good as the registrar’s worst client. Quality Manuals are intended to define the intent of your supplier’s Quality Management System, while most of the details are located in procedures. You only need a copy of your supplier’s Quality Manual to help you plan audits. Supplier questionnaires seem to be the most popular tool, but most of the questions require a “Yes/No” response that suppliers rarely answer negatively. To assess the qualifications of potential suppliers more effectively, try using the following tools instead:

Tool # 1: Statistical Process Control

Most companies require a Certificate of Compliance (CoC) with every shipment. A CoC is useless. Just like the “Yes/No” responses to questionnaires, you will never see a CoC that indicates something is wrong. A Certificate of Analysis (CoA) is much more useful, because the CoA has actual data, and the tolerance range is typically indicated for each test or measurement that was performed by the supplier. The best report you can get from a supplier is a statistical analysis of each specification during the prototype production lot. When you have a Statistical Process Control (SPC) run chart, you know quantitatively if the supplier is capable of making acceptable product. The run chart can also be used to develop an appropriate sampling plan for incoming inspection.

Tool # 2: Process Validation

Process validation is much more than determining if a process is capable of producing a consistent product. An SPC run chart can do that. Process validation tells you what range of operating parameters will produce a consistent product. Therefore, when you have process deviations or measurement devices are slightly out-of-calibration, you will know if your supplier’s process will still make acceptable product. The validation of a process should also identify which variables are critical indicators of the process. This information can be used to reduce the number of variables and specifications that are monitored for a production process, and focus both your supplier’s resources and your own.

Tool # 3: Supplier Auditing

A multi-disciplinary team audit of a potential supplier is an effective tool for assessing a supplier’s qualifications, and will help build a stronger relationship between your team and the supplier’s team. Before you conduct an audit, it is important to plan the audit to ensure you get the greatest possible value. The following recommendations are important to supplier auditing:

  1. Use a risk-based approach to auditing suppliers (this goes beyond just critical and non-critical)
  1. Strategically select auditors and train them well
  2. Plan the auditing goals and objectives for the team in advance
  3. Create a formal audit agenda that defines which processes each auditor will be focusing on

Auditing 100% of your critical suppliers may seem impossible, due to limited resources, but have you ever seen a cost/benefit analysis?

What’s the cost of rejects, rework and product redesign?

Supplier Quality Management Webinars Available 

Are your Suppliers Qualified? Prove It! 

http://robertpackard.wpengine.com/suppliers-qualified-prove/

Supplier Auditing and Remote Auditing: Tips to Save You Time and Money 

http://robertpackard.wpengine.com/supplier-auditing-and-remote-auditing-tips-save-time-money/

 

 

 

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The Vendor Audit Agenda: Where to Spend Your Time

This blog discusses the importance of reviewing previous quality issues, and specific areas where the author likes to spend his time during a vendor audit.

When you attend a lead auditor course, the focus is on Quality System auditing. However, when you perform a supplier audit—the Quality System is not the focus. The focus of a supplier audit can fall into two primary categories: 1) qualifying the supplier, or 2) re-evaluating the supplier.

Suppliers are not required to have a registered Quality System. Therefore, many of the things that an auditor might learn about audit agendas in a lead auditor course just don’t apply. However, one thing always applies: reviewing previous quality issues. When I audit internal auditing and supplier auditing programs, I find that one of the most common mistakes is failure to close-out previous nonconformities. Therefore, the second section of my audit report template is a review of previous audit findings. If you have no previous findings, ensure your audit report states that. If you are qualifying a new supplier, ensure that the new supplier doesn’t have the same problems you are having with current suppliers.

When you close the previous issues, there are two approaches. The first approach is close previous issues at the beginning of the audit—immediately after the opening meeting. This is the most common strategy. The second approach is to close previous issues as you audit the applicable area. For example, if you have previous issues in the area of incoming inspection and maintenance records, it might make sense to close these findings when you audit these areas. The advantage of this second approach is that it ensures that the process owner is closing the previous finding and facilitates the sampling of additional records.

What has little value in the supplier audit agenda? Auditing the Management Review process has the least value, because the supplier is not required to have a Quality Management System. In fact, subcontractor audits for BSI never include management reviews, CAPAs or internal audits—the three required areas for every quality system audit.

Most Valuable Areas to Audit?

Incoming inspection, control of nonconforming materials, preservation of product, production controls, training and process validation are the areas I typically audit. I like to start in the nonconforming material area and see which materials are on hold. Then I like to sample the incoming inspection records for those raw materials. Next, I like to see how the company is storing those raw materials—if they are accepted. I typically cover these three areas as one process audit. This also happens to be the process audit I like to use for training new auditors, because the audit of incoming inspection results in numerous audit trails in the support process areas of document control, training, calibration, etc.

The next area I will visit is the production area. For this portion of the audit, I am doing a process audit of the production process. I usually request that we schedule the audit for a time when the production area is actually running the product(s) of interest. A process flow chart is helpful in planning this portion of the audit, and I will often write some notes directly on a copy of the process flow chart.

I conclude the audit with follow-up trails in the areas of: 1) document control (to ensure the supplier has the most current versions of all documentation “we” provided), 2) calibration (to ensure that all  measurement devices used for inspection are calibrated), and 3) training (to ensure that all personnel working on “our” product are properly trained).

Since I do not have to spend time on Quality System issues during a supplier audit, I spend more time sampling records in the other areas. Therefore, I might sample 5-10 records in each of the above areas instead of 3-4 records. In fact, if the number of samples available to sample is small, I may even sample 100% of the records.

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The Supplier Survey with a Twist

This blog suggests that your supplier survey form need be only one page to contain pertinent supplier data information.

I must admit, the first supplier survey I ever used was copied from another company and we just changed the header. You might think this is quite unethical, but get real. I have seen that exact same survey form during at least a dozen audits I have done over the past decade. I have also had to fill out that document.

You know the one…it’s 29 pages long and asks you a bunch of inane questions that nobody will care about.

Supplier Survey Suggestions

To fix the mess we have all created, I have a few simple suggestions:

  1. Don’t copy another supplier survey form. Make your own form instead
  2. Cut your survey down to ONE page
  3. Focus on collecting supplier information first
  4. Require suppliers to update this form at least annually, or when they change something
  5. Ask open ended questions

29 pages is insane. Who thought that was a great idea? Personally, I think the theory behind this approach is that we will screen out the really poor suppliers that don’t want our business in the first place. In reality, management delegates the completion of this form to a subordinate that they want to punish. I don’t think I need to explain the theory behind a one-page document.

You need supplier contact information, size of the facility, number of employees, shifts, website, software capability, etc. This is obvious information that you need to know about your supplier.

Make sure you give the supplier this form in MS Word format, so they can fill it in with minimal effort. Next year, when you want them to fill it out again, give them the original in MS Word format, so they can redline changes. This makes it easy to see what changed and reduces the effort required to update this annually. Why do you need a signature and date on this stupid form? I do not know. If you can think of a good reason, go ahead and make your supplier sign and date the form. If you can’t, don’t require a signature and date just because everyone else does.

You should have a supplier agreement that requires notification of changes. This should include significant changes to the QMS. Updating the supplier survey is a great way to do this—especially if the supplier can redline the previous version.

Closed-Ended and Open-Ended Questions

My last suggestion is probably the most valuable. Remember the difference between closed-ended and opened-ended questions. “Closed-ended” questions ask for a response of “Yes” or “No.” It makes it easier to complete 29 pages in less than a day, but it’s also easy to identify the answer that the customer wants to hear.

For those of you that have Canadian Medical Devices Conformity Assessment System (CMDCAS) certification, take a look at GD210 sometime. The back of this document has a checklist with clause-by-clause questions. 100% of these questions are “closed-ended.”  Here’s an example: For clause 5.6.2, the GD210 checklist asks, “Is a review of new or revised MDR part of the input to management review?” Examples of “open-ended” questions related to clause 5.6.2 would be:

When was your last Management Review?

  1. What were the new or revised regulatory requirements discussed in the last Management Review?
  2. Who was in attendance at the last Management Review?
  3. How many action items resulted from the last Management Review?

You should notice that not only are these three questions open-ended, these are all non-proprietary questions that a supplier should be willing to answer.

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Supplier Risk Management: Which Suppliers Should You Audit?

This blog presents a few thoughts on supplier risk management related to criteria in evaluating suppliers and determining which suppliers you should audit

There are two criteria that are the most popular for evaluation of suppliers:  1) percentage of lots accepted, and 2) percentage of on-time delivery. Both of these metrics have potential limitations. For example, what if a good supplier ships only two shipments this year and there is a problem with one shipment? The reverse is also possible. What if a poor supplier ships lots every week? Ten bad lots per year will result in an 80% quality rating.

On-time delivery has other issues, such as, does purchasing update the due date in the MRP system when they ask suppliers to push out the delivery date due to soft sales volume? If a supplier expedites an order in half the normal turnaround time in their “best effort” to meet your requested due date, should they receive a negative result for percentage on-time delivery if they are one week late?

The points above help identify limitations of supplier metrics. In the end, if you have a critical supplier—there is no substitute for auditing them. Unfortunately, auditing costs money. So which suppliers should you visit?

The “critical suppliers” is often the answer, but how do you decide who is critical? Well…benchmarking is a good idea. For example, a Notified Body (NB) must audit “critical suppliers” that do not have ISO 13485 certification. They define “critical” as subcontractors that perform high-risk processes, such as contract sterilization, subcontractors that perform contract packaging and suppliers that manufacture finished devices. Health Canada even provides some guidance on the definition of critical subcontractors, and how the NB shall determine which “subies” need to be audited.

Internally, your supply chain and quality assurance team have to develop a list of suppliers that will be audited. In general, I recommend that all “critical” suppliers be audited at least once every three years (equal to the certification cycle). However, your auditing schedule is a plan that should have “wiggle room.”

For example, if you weren’t planning to visit an existing supplier until next year or the following year, and suddenly there is a new quality issue with that supplier, you may want to add a “for cause” audit of their facility to your supplier audit schedule. You might want to add suppliers in close proximity to another supplier you were going to audit anyway in order to reduce travel costs.

Practically speaking, you might decide to audit your 10 worst suppliers each year. This might be determined by qualitative, cross-functional rankings, rankings for nonconforming materials, or by the number of supplier corrective action requests. There is no “right” or “wrong” way to determine which suppliers should be audited. However, the best companies have strong supplier quality programs to reduce scrap and the need to perform inspections.

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Supplier Qualification Selection Criteria

This blog discusses an auditor’s criteria for supplier qualification and selection, including proximity, technical expertise, size, etc.. 

I suppose there are a lot of possible answers to this question. I would avoid answers like, “because that’s who we’ve always bought ‘widgets’ from.” “Grandfathering” suppliers is a VERY BAD IDEA! I’m sure I’ve made this analogy before, but I’ll repeat myself anyway. Would you keep an employee that was totally unqualified for their current position just because they were qualified for the job they were hired for initially?

Please don’t answer that question. I’m afraid that some criminally stupid manager might say yes. I am a strong proponent for fairness and training people, so they can be promoted from within. Unfortunately, sometimes people just can’t keep up with the growth of the company. This happened to Charlie’s Dad in the movie Willie Wonka, and it can happen to the genius founder and CEO of a growing company.

Training

If I have an employee that is not qualified for their job, I start by retraining them. I love to teach, so I probably spend too much time trying to train someone that might not have the aptitude. I like to use the approach of training people until they get it right or they quit. “Quitting” doesn’t necessarily mean leaving the company. It could mean applying for a different job. It could also mean some out-placement coaching from a consultant. No matter what, I try to make it work first—then I terminate. When I terminate, I do so with kindness, compassion, legally and with ample notice.

Suppliers should be handled no differently. You should re-evaluate your suppliers on a regular basis and terminate your contracts with unqualified suppliers. This will probably require the same level of diplomacy (e.g., – retrain them, identify an alternate, and negotiate a transition plan that is reasonable for all parties).

Another stupid answer is, “because they were the lowest bidder.” There’s an old government contracting joke about this strategy. I think it sounds something like this, “a million mission-critical parts, designed by engineers that have no clue what the real world is like, built by the lowest bidder, and inspected by a bureaucrat that can be bribed with a bottle of wine and some prime rib.” Personally, I tend to discount the quality of the lowest bidder every time. I always wonder what they forgot to consider when they bid on the job.

If you have read my previous blogs, you already know that ISO certification is not an important criterion for me. I include the thoroughness of a supplier’s questions as one of my semi-quantitative criteria for selection. Another factor I like to use is proximity. I believe there is great wisdom in developing a partnership with your supplier. It’s a lot easier to achieve that kind of relationship with another company if they are located close-by. Another thing I look for is a supplier that is better than my company. I would much rather learn best practices from my supplier than spend my resources teaching them to become better.

Same Size Supplier

Finally, my favorite criterion is size. I prefer a supplier that is approximately the same size as my company. If we are the same size, then problems should be equally important for both of us. If my company is bigger, we might tend to bully the supplier and the supplier might have difficulty growing with us. If my company is smaller, our problems might not receive the attention they deserve.

There are always other considerations, such as the desire for “one-stop-shopping” to increase your bargaining power. Unfortunately, this approach tends to result in sub-optimal decisions and it makes it more difficult to terminate relationships. Technical considerations are also important, but I rarely find that a good supplier does everything well. It’s sort of like hiring an employee with the perfect resume. They should be a qualified candidate—on paper. Unfortunately, the fit of an employee with a company is equally important. For example, if your engineers are sloppy when it comes to writing a specification, you don’t want to qualify suppliers that will build whatever you ask for—no matter how stupid it sounds.

My SIMPLE advice…Qualify suppliers based upon the intangibles AND the technical details.

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Qualifying a Supplier That Doesn’t Have a Quality Management System

This blog proposes a simple solution for how to qualify a supplier that doesn’t have a quality management system.

Ignoring the obvious question of why doesn’t a medical device supplier have a quality management system…If you are a contract manufacturer, you should ensure that you have a clause in your supplier qualification procedure that says you don’t need to qualify suppliers that are mandated by your customers. If your response to this suggestion is “Duh,” you haven’t conducted many supplier audits of contract manufacturers. As my buddy Tim says, “You need to leave some ‘wiggle room’ in your procedures.” This is also good advice for all 19 of your top-level procedures that get audited each year.

For the remaining suppliers you are considering to add to your Approved Supplier List (ASL), you need a SIMPLE set of criteria for how you qualified the supplier. Guess what that magical document should be? (Answer to be provided shortly…)

Many companies use a supplier self-evaluation survey. I’m almost certain that I have bashed these nearly useless documents before, but if I failed to do this…most of them are problematic. A one-page supplier information form seems more appropriate. No signature required! And please make it a Word document.

The supplier qualification procedure needs to be generic for all raw materials and services you purchase. The problem is that everything you purchase has different requirements. So instead of wasting your time with writing one procedure that has wiggle room for every single product or service you will ever purchase, don’t even try. Instead, write a SIMPLE procedure. This procedure needs only be one page long. It needs four requirements:

1)      New suppliers must complete a supplier information form and submit it to the company. This should be updated at least once every 12 months, and whenever there is a change to the information provided (i.e., – notification of change).

2)      You need at least two people to approve the addition to the Quality Management System. This can be done on your ECO or DCO form for changing the ASL. If the supplier is customer-mandated, you need the customer’s approval and the purchasing managers. If the supplier is internally selected, you need at least purchasing and QA to approve it.

3)      You should have objective criterion (probably more than one requirement) that are product/service related for acceptance of the supplier. This criterion SHALL be under document control and the revision shall be communicated to the supplier when orders are placed. See ISO 13485:2003, section 7.4.2 (Purchasing Information).

4)      Finally, you need a reference to your purchasing procedure (one of the required 19 documents) and your supplier re-evaluation procedure.

If you have not already guessed, the “magical” document is called a purchasing specification or raw material specification for raw material items. For capital equipment, you may require that a capital expenditure justification be completed in lieu of the purchasing specification. For a calibrated instrument, tool or fixture; you may require that requirements of the instrument/tool/fixture are documented in the applicable procedure or work instruction. For example, for measurement of this cannula, a calibrated optical comparator is required with 20x magnification. Reference the inspection procedure or drawing and you are done.

For those of you that would like to keep your ASL shorter, which I recommend, if you don’t think you will be using the supplier more than once, you might want to give the buyer the option of documenting the purchasing specification on the purchasing requisition instead. This might be very helpful for those engineers that are doing R&D or validation work. For example, I need a bag of resin that meets the following raw material specifications—but we don’t currently use this material and I’m not ready to submit one for approval. That’s why the engineer is ordering the bag of resin. She needs to test the material in the application and gather some preliminary data as justification for the new raw material specification.

There are 100’s of other ways to qualify your suppliers, and many of them work well if you follow your procedure. If your procedure is SIMPLE, your Monday’s will be better.

 

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Supplier Management: Who Should Be Conducting Supplier Audits in Your Company?

This blog reviews which an important supplier management issue; which personnel should be conducting specific types of audits for the company.

Today, I would like to start by asking a question: Who does supplier audits at your company?

I believe that there are three primary purposes for conducting supplier audits:

1) “For cause” audit, where the auditor is investigating the root cause of a nonconformity

2) Qualification audit, where the auditor is assessing if the supplier should be added to the Approved Supplier List (ASL)

3) Re-evaluation audit, where the auditor is verifying that the supplier is maintaining proper production controls

The problem with these three audits is that most companies send the same people—regardless of the purpose. Usually companies send a purchasing manager or a supplier qualify engineer to conduct supplier audits. Occasionally, the two will do a team audit. Resources for auditing suppliers are tight in most companies. Therefore, I do not recommend this “one size fits all” approach. Instead, I believe that each purpose should be matched up with a specific type of auditor.

“For cause” audits need a supplier quality engineer who has strong investigational skills and will be able to identify the root cause(s) of a nonconformity. The auditor should also be capable of training the supplier on how to respond effectively to a Supplier Corrective Action Request

Qualification audits are ideal opportunities for a team approach. There are quality issues to consider, but there are also financial, scheduling and capacity issues. A cross-functional team approach works best in this case. A team also reduces the potential for biased individuals making inappropriate recommendations.

Re-evaluation audits should not be conducted by purchasing or supplier quality engineers. The reason is that neither position is typically responsible for performing incoming inspection. If you don’t perform inspections regularly, you may not be aware of all the problems to search for. Therefore, I recommend using QC inspectors for this activity. QC inspectors know exactly which quality issues have been found recently, because the QC inspectors identify the defects during incoming inspection, in-process inspections and during final inspections.

I don’t think that my approach to “For Cause” or Qualification audits is unusual. However, using QC inspectors to perform supplier audits is uncommon. There are two other reasons why I believe companies should consider this approach. First, inspectors would get a rare opportunity to go on a business trip and be reimbursed for the travel. For those employees that rarely travel, this can be an opportunity for recognition by management and a perk (i.e., – free meal, lodging and travel). Second, supplier quality engineers could easily fill in for a QC inspector to become more familiar with parts and components, as well.

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Taking a Risk-Based Auditing Strategy for Evaluating Suppliers

This blog makes the case for taking a risk-based auditing strategy for evaluating suppliers.

None of us has unlimited resources. In fact, the pendulum has swung so far that “do more with less” has now become “do everything with nothing.”

Here’s a familiar situation…During your most recent annual surveillance audit, the auditor gave you the bad news…“The Canadian MDR requires that you audit critical suppliers that do not have ISO 13485 certification, and these two contract manufacturers should be added to the critical supplier category.” Once your blood pressure drops enough, so that you are not in immediate danger of having an aneurism, you might think to ask your auditor how frequently these audits need to be performed. Most auditors will allow a three-year cycle between supplier audits, but this is because of the three-year recertification cycle.

Your company should really adopt a risk-based strategy for evaluating suppliers. For high-risk suppliers, an annual or six-month cycle is appropriate. For moderate-risk suppliers, biannual or three-year cycles might be more appropriate. A supplier I audited recently told me a story that illustrates this concept.

Their company noted that the FDA was inspecting them every seven years—instead of every two years (FDA’s goal for Class 2 devices). The FDA investigator explained that the local office only had enough resources budgeted to perform 50 inspections per year. Each year, they start at the top of their priority list and work their way down the list. Each year that this company fell below the 50-company cut-off, the company moved up the list for the next year. It took them about seven years to reach the top 50.

In your company, you have a limited number of Supplier Quality Engineers (SQEs) that are available to audit your suppliers. Since SQEs have lots of other job duties, in addition to on-site auditing, I recommend the “Take 5” approach. What I mean is: 1) prioritize your list of suppliers based upon risk (including how long it has been since their last audit), 2) pick the top five highest risk suppliers and schedule those audits throughout the year, and 3) hire another SQE for every fifteen suppliers (five supplier audits/year/SQE x three years/cycle = 15 supplier audits/SQE/cycle) that require onsite auditing. The number “5” is arbitrary, but “5” is in the right order of magnitude.

SQE’s are responsible for monitoring supplier performance, issuing Supplier Corrective Action Requests (SCAR), follow-up on SCARs, updating drawings, communicating revision changes to suppliers and qualifying new suppliers. If an SQE is doing more than five onsite supplier audits per year, it will be important for these suppliers to be local. Otherwise, these valuable employees will get burned out fast.

Review your own Approved Supplier List (ASL) and ensure you have properly identified “critical” suppliers. Review your supplier evaluation procedure to ensure that it gives you the flexibility to revise the audit frequency on a risk basis. Finally, review your SQE resources…hiring, recruiting and training a new SQE every two years will cost as much as adding an SQE when the ratio of supplier audits per auditor has exceeded the magical number “5.”

 

Posted in: Supplier Quality Management

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Supplier Evaluation – Less is More

This blog makes the case that higher frequency of data collection and data analysis is more important than more data related to supplier evaluation.

Most of the procedures supplier quality engineers write are comprehensive. We all want more data because we believe it will help us make better decisions, but I believe simple systems are often more successful.

For example, the following system uses just two metrics: 1) the percentage of orders delivered on-time, and 2) the percentage of nonconforming lots. The reason why this works well is that companies can generate automated reports quickly and frequently. More frequent reviews of suppliers are more effective than annual comprehensive reviews. This is the same argument used for planning internal audits. Most companies favor monthly internal process audits instead one annual full-quality system audit.

If you want to add more inputs to the supplier evaluation process, think carefully about how difficult it is to collect data and how frequently reports should be generated. Aging of Supplier Corrective Action Requests (SCARs) is a great metric to track, but if a supplier only receives one SCAR per year—how frequently would you run this report?

To be useful, you need metrics that provide almost real-time feedback. Statistical data on process capability for critical dimensions, or final testing results is available for every production lot. These metrics are also likely to change from lot-to-lot. Asking suppliers for this type of data involves weekly or monthly interaction with the supplier. As I stated earlier, higher frequency of data collection and data analysis is more important than more data.

Lot-specific data can be used to justify sampling plans for incoming inspection. You might even ask the supplier to graph the data and provide a brief analysis of the results. These are value-added services that suppliers can provide—and should already be performing in an ISO 13485 Quality System. Regular review of in-process and final inspection data also forces regular interaction with suppliers. The combination of real-time data, applying statistical techniques and communicating regularly with suppliers is the key to successful supplier management.

Posted in: Supplier Quality Management

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