when systems fail, capa validation begins

0 Special Edition: Corrective and Preventive Action Vol. II0

When Systems Fail, CAPA Validation Begins

INTRODUCTIONThis article deals with developing a systematic CAPA

program specifically addressing todays regulatory require-ments. Not only does the U.S. Food and Drug Administra-tion (FDA) require programs for Corrective And Preventive Action (CAPA), but also many of us must comply with in-ternational requirements, and the analysis system in CAPA is one of the most critical items in a Quality System. As part of our considerations here, we will examine the:

Nine-Step CAPA Program

Requirements of an Effective CAPA Program

Regulatory Expectations

Preventive Action Considerations

An Appropriate CAPA ProgramFDA reported this past year (2006), that many compa-

nies do not employ effective CAPA systems. Typically, the FDA sees 30% to 50% non-conformance in any given Warning Letter. These are generally CAPA-related issues. In one of their meetings, the FDA noted that 76% of all Warning Letters for 2004 had CAPA-related issues. That is an overwhelming percentage, and it occurred because these companies did not do a good enough job not only of identifying corrective and preventive actions, but they did not validate the effectiveness of their plans. They did not verify that the corrective actions they employed were actually effective.

A compliant CAPA system will: Include Preventive Action Program Tie in Design Control procedures Tie in Process Control procedures Tie in Risk Analysis (FMECA, FTA, etc.)

Corrective and preventive action procedures require: Analyzing processes, work operations, concessions, qual-ity audit reports, quality records, service records, com-plaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems.

NINE STEP CAPA PROGRAMTo establish an effective CAPA program, there are nine

steps to be performed as follows:1. Identify Problem2. Gather Information3. Analyze Data4. Perform Root Cause Analysis5. Complete Action Plan6. Implement Action Plan7. Follow-up Action Plan8. Verify Effectiveness of Action Plan9. Confirm Preventive Action

1. Identify ProblemThe first thing, of course, would be to identify that there

is a problem. Oftentimes we see symptoms and we do not stop to acknowledge that there actually is a problem. We first must identify the problem reflected in the symptoms. Write a detailed problem statement. The problem state-ment should include where the event happened, what hap-pened, when it happened, who was involved, how many pieces of whatever were involved, and how the event oc-curred. Doing a thorough job of identifying the problem is step number-one.

By IVT StaffBased on a Teleseminar given by Jackelyn Rodriguez, September 20, 2006

Special Edition: Corrective and Preventive Action Vol. II

Compiled by IVT Staff

2. and 3. Gather Information and Analyze Data

Once the problem has been identified, then we start gathering data for the data analysis. This is the beginning of the investigation for the root cause. Data analysis begins by considering what information is needed. We do the analysis and gather the data as interrelated steps. We may go back and forth between the two steps, especially at the beginning, while we are discovering what information is needed. Go back to the well of information until you have everything you feel answers the outstanding questions.

You may be looking at batch records, complaints, ser-vice reports. You are gathering the information you need to perform the data analysis, which is the third step in the program. As you are doing the investigation, you must ask: what are the procedures or what are the processes

involved, what is the equipment, what has changed, are these the correct procedures? Keep asking questions until you have satisfied every open issue To obtain the infor-mation you need and to have a clear understanding of the event, you may start interrogating people talking to people who work on the processes or procedures. Keep asking questions to get all the information and documenta-tion you feel is necessary in order to perform an effective root cause analysis.

Once you have all the data in front of you, even as you are analyzing the data, things may be falling into place. You should be thinking of different ways to look at the data. Try a fault tree analysis, or a fishbone, or other chart types to look at the data in new ways. Each of these tools can help you see the information in a different light.

Figure 1Nine-step CAPA Process



4. Perform Root Cause AnalysisThe fourth step is the performance of the root cause

analysis. Once the data is analyzed, pull it all together to get to the root cause or causes of the problem. Like a detective solving a mystery, some aspects may appear obvious while others may be more obscure. You may have to return to the data time and again for clarification while you consider and eliminate possibilities until you arrive at the root cause.

5. and 6. Complete Action Plan and Implement Action Plan

With the identification of the root cause, the next step is to develop an action plan. An action plan is completed to determine what will be done, who will do it, how it will be done, where it is going to be done, etc. Ensure that you have a list of things that are going to be implemented to allow for effective follow-up and confirmation of everything that is to occur.

7. Follow-up Action PlanDuring and after the implementation of the plan, some-

one must follow-up on the work being performed. The action plan must be written so that independent follow-up may be completed by appropriate inspectors. This plan will be challenged by regulatory agents both external and internal, so it should be precise and thorough. The follow-up will help confirm that the things that were supposed to have been done have actually occurred. This process will confirm, for example, that the follow-up was effective, that the procedures were changed, that people were trained, that equipment was updated, and that everything hap-pened as specified in the plan

8. and 9. Verify Effectiveness of Action Plan and Confirm Preventive Action

Closely on the heels of the follow-up or perhaps at the same time, the verification of the effectiveness of the cor-rective action will be conducted. In step seven, the follow-up confirmed that what was supposed to occur actually happened. The verification of the effectiveness of the ac-tion plan will be the crucial test and the culmination of the previous seven steps.

At this point, we want to make sure that what has been implemented as a corrective action has actually cured the problem. We must verify that our action plan has ef-

fectively eliminated the problem. If that is so, then we can implement it in other systems as a plan of preventive ac-tion. This will become the preventive action that we want to implement at a later time.

If we find that the chosen action has not cured the prob-lem or has addressed only part of the problem, then we must go back through the program steps and either re-analyze the data (step 3) or perhaps get further data (step 2) until we discover the actual root cause or total root cause or causes (step 4). Or, we may only have to go back a few steps to the implementation of the action plan (step 6) to discover that there was a flaw in the way our solu-tion was applied. We must backtrack as far as necessary along the process to discover the flaw and correct it - even if that means restating the problem (step 1) - to find the correct root cause (step 4) to have a truly effective action plan (step 5).

REQUIREMENTS OF AN EFFECTIVE CAPA PROGRAM

The FDA will not dictate the degree of action that should be taken to address a quality problem, but they do expect companies to have plans in place. They expect companies to address how they will perform their investigations, how they will determine probable root cause or causes, and how they will implement corrective actions. What is more important, the FDA will follow-up to see that the plans that are in place are effective.

Corrective action is a reactive tool for system improve-ment to ensure that significant problems do not recur. Both quality systems and the current Good Manufacturing Prac-tice (cGMP) regulations emphasize corrective actions.

Quality systems approaches call for procedures to be developed and documented to ensure that the need for action is evaluated relevant to the possible consequences, the root cause of the problem is investigated, possible actions are determined, a selected action is taken within a defined timeframe, and the effectiveness of the action taken is evaluated.

Data CollectionBegin by looking at the methods to be used to collect

the information. In order for the CAPA program to work, the data to be analyzed must be appropriate to the sys-tem. Ensure that the data is sound, that it is not junk data - and last years statistics have limited value for the com-


pany. Look at data on a timely basis. Identify who will look at the data, determine how you are going to measure it, and monitor the activities that are going to be used for a CAPA prospective data analysis. Determine when you will perform the analysis or the evaluation of the data collec-tion activities.

One important element within the CAPA program is the collection and analysis of data to identify all the things that could be a potentially non-conforming product issue. For example, let us say we have noticed rework of procedures or rework of product. Those are telling quality indicators that we should not ignore. The existence of rework indi-cates a quality problem; if you rework, you have a problem. Either you are not manufacturing the way you are sup-posed to be or you are deviating from the process. Under these circumstances, you want to make sure that within the CAPA program you require an investigation.

During the investigation, you must look for causes; do not take the Band-Aid approach. Identify appropriate corrective action that will prevent the issue from recurring. Verify and validate effectiveness. Do not merely confirm that something happened. For example, if an SOP was re-vised, find out why it was revised. If that SOP was revised because steps were lacking on the procedure and you had non-conforming issues as a result, you should then validate the effectiveness of that corrective action. Moni-tor over time, maybe over a month, or over three months, whatever length of time is appropriate. Then, when the offending issue has ceased occurring, document that you have monitored and validated the effectiveness of that cor-rective action. That way, you have thoroughly completed the process; you have closed the loop. You have effec-tively eliminated a problem and you know it will not recur, because you have tested and monitored its elimination. You have validated the effectiveness of your action plan.

CommunicationAnother very important aspect will be that you commu-

nicate with folks who are close to the problem and who will be using the new procedures involved in the events in the investigation. Do this so that people know what has happened. The people who are most closely related to the process should understand what has been done to address the issues. This gives you an informed, educated manufacturing team. People who are respected and given the information they need to do their work perform better,

have better attitudes, and generally, are more satisfied workers.

All that information is going to be symptom manage-ment, with the management review criteria and the need for review of CAPA, from the pharma side and the Annual Product Review (APR) process as well. We are looking at non-conforming deviations here and all such information is to be reviewed by management. This is another thing the FDA will be looking for - has management been properly apprised of ongoing manufacturing situations.

It is not just the verification that must be done. It is not merely the follow-up that must be completed, but also the communication of these changes that must occur. Com-municate the changes - whether they are procedures, equipment changes, manufacturing, or environmental changes. All of these should be communicated to the folks who are directly responsible and to those who work with the systems and processes. The information should also go to management, so we have a closed loop system. This way, everyone will be properly informed.

ProceduresSome of the requirements for an effective corrective

and preventive action program include the fact that we have procedures that clearly define who does what, when, where, and how. It is the Standard Operating Procedure (SOP) that describes what needs to be done, when to evaluate data, how to evaluate data, how to discover the root cause, how to implement corrective actions, and how to verify effectiveness. All of this should be in the CAPA procedure. There may be subset procedures such as an investigation procedure or a root cause analysis proce-dure; however, you must ensure that all procedures are clearly linked within the system to form a consistent, uni-fied CAPA procedure.

When regulatory agents start looking at your CAPA pro-gram, they follow the process you have established to identify what they are going to monitor. Ensure that within the system you have identified the full requirements for each procedure. For example, your investigations should identify any recurring problems and indicate the next steps for taking care of recurring problems. Next steps should be thoroughly described and documented in the SOPs. A systematic approach to analyzing next steps should be outlined along with the prescribed method of implemen-tation.



Again, indicate the inputs that are going to be looked at to determine probable root cause. How will you document them? When identifying root cause, point out how you will implement the appropriate corrective action, because agencies, both FDA and European authorities, will be look-ing for these details. They will challenge the process to see whether you are actually identifying all of the stated inputs. Besides the stated inputs, they will be investigating all of the things that should be analyzed to see whether the system has any conceptual flaws.

Next, describe the action plan. Indicate how the action plan should be implemented. Layout the projected impact of the action plan; indicate assessment tools. Once root causes have been pinpointed and shortcomings within the Quality System are uncovered, indicate what will be done from a short-term perspective and from a long-term perspective - depending on the criticality of the corrective action - to bring the situation back into compliance.

Regulatory Agencies are going to try to determine whether investigations are being conducted to uncover the root cause. Not just Band-Aiding the problem, not just retraining people, but actually understanding whether a problem stemmed from a system, a procedure, or an equipment failure, and getting to its root cause. Linking your decisions to risk-based factors is an important indica-tion that you have learned to look beyond singular issues to preventive action. Risk-based decision-making focuses on thinking proactively, taking action where things have not yet happened, and implementing actions to prevent problems from ever occurring.

Some other important steps in the corrective and pre-ventive action program are to determine whether the fail-ure investigation procedures have been followed. Write a procedure that indicates how an investigation should be completed. Include the tools that should be used in an in-vestigation. These will determine the degree to which your quality problem or non-conforming products investigation is connected to a level of risk. The significance of the non-conformity should always connect to an established level of risk management. This is a sign of a well thought out plan and a firm knowledge and understanding of the inter-relationships of your products and processes.

TrendsMake certain that you look at the right inputs. We want

to make certain that we look at the sources of information that are going to give us well rounded information on the Quality System to understand whether we have issues in testing, do we have issues in vendor performance in our recurring reject or recurring quarantine of incoming prod-ucts to complaints.

When you start looking at your CAPA program, and you begin observing the trends, you will probably see clusters of data. You will be able to see more of the big picture - that you actually do have recurring issues. Seeing this data, you should take a more serious approach to the problem. Eventually, as you continue to trend your data, you will not (and should not) wait until you see data clus-ters. As you analyze the data on a routine basis, take the actions you need to as they become apparent to you.

Another important thing, from a device perspective, would be that if you see problems recurring, link these corrective actions to other systems. For example, a design change occurs because there is a new use for the product that was not originally intended. There may be a need to change the product design to address the new issue. If our users are using the product incorrectly, are we changing the labels? We have handled product complaints; now we have significant new data. What are we doing with this in-formation? Are we linking it to other systems to make sure that the problem uncovered by the complaints is being addressed at all levels; in all divisions within the company? Set-up the CAPA system such that all aspects of the Qual-ity System are linked and talking to each other. This type of data should be captured and put to immediate use in other relevant areas.

Always look at the analysis of data. If there are recurring issues in areas that previously have been identified for cor-rective action, then the corrective action was not effective. That means you are Band-Aiding. That means you need to analyze again for the correct root cause. Trending will give you the information you need. Trending will show whether the system is steadily improving or whether your actions effectively Band-Aid issues rather than directly address the root cause.

The best indicator of how our product is performing in the market is the level of complaints. That is the number-one feedback mechanism from our customers on how happy or unhappy they are with the products effectiveness. Why



are they complaining? What are our products doing and are we learning from these complaints? Are we learning and perhaps changing our products because, perhaps, we did not take into consideration certain aspects that should have been changed from the initial design review or from the initial design development of a process?

Make sure that you look at the complaint data. When FDA comes into your facility, they will challenge your data. They are going to see whether you are looking at all of your data and they will observe the things you are look-ing at. Do the procedures identify everything that you are going to look at? When will you be looking at the trending of the items, the non-conforming issues, the complaints, the MDRs, the adverse event reports? Make sure that you are looking at those quality indicators so that you can take appropriate corrective action on a timely basis. The au-thorities will want to know that the information is accurate, complete, and timely. The Agencies will verify and confirm that the company is taking the right actions and note when the actions are being taken.

REGULATORY EXPECTATIONS

Root Cause IdentificationCurrent FDA expectations of a CAPA program include

a sound understanding of the product, ability to evaluate all the things that could possibly have caused the event - allowing us to get to the root cause of the problem - in-vestigating the problem thoroughly, and comprehensive knowledge of the possible actions to be taken once we de-termine the root cause. From an FDA perspective, and also from an ISO perspective, Regulatory Agencies demand that we go far beyond momentarily eliminating obstacles. We need to define and understand the root cause to cor-rectly analyze the problem. Once we determine the root cause or causes, then we can begin to identify possible corrective actions. The regulatory expectation is that we identify not only what the problem is, but what its cause is, or what the many causes of that problem may be.

Because of this expectation, it also must be in our plan of action to indicate what we are going to do to implement the corrective action, and then within that plan of action, we need to identify what is the defined timeframe in which we are going to act. The last part of the corrective action requirement is that we validate the effectiveness of the action that was taken. Therefore, we are required not only

to take action, but through monitoring, through verifica-tion of effectiveness, to confirm that the corrective action was effective.

When determining the whys, it is critical to determine the reason an event or failure occurred, and to specify workable corrective measures that prevent future events. Understanding why an event occurred is the key to devel-oping effective recommendations.

QSIT and CAPAFrom the Quality Systems Inspection Techniques (QSIT)

perspective, we know that when FDA does a follow-up in-spection, they have the mandate to establish a CAPA plus 1 for companies that are compliant, that is, if the company has no Warning Letters or regulatory issues with FDA. That is the standard system of doing an inspection. They per-form an inspection using the QSIT approach and always start with CAPA when it is a surveillance inspection. FDA will always look at those elements of a CAPA program. For this reason, it is very important to become familiar with the QSIT approach and to read the QSIT Handbook.

Elements of the handbook are too lengthy to review in this article. However, the author/ presenter strongly sug-gests, that the reader download the handbook to under-stand the elements and objectives that FDA looks at dur-ing a QSIT inspection. Pay particular attention to the FDA objectives on inspection items used for facility inspection to understand whether your company is collecting the right information, analyzing the right information, identifying the quality indicators that FDA uses, and taking the appropri-ate corrective and preventive actions.

You will also read there how they follow-up and verify effectiveness. Within the purpose of the QSIT Handbook approach from a CAPA perspective, there are several in-spectional elements that FDA looks at when they are look-ing at the CAPA sub-systems and it would be well worth your time to review the handbook for these particulars to understand FDAs thought processes. It will give you Quality System requirements from the QSIT inspection perspective, which can be very helpful.

Importance of Continuous ImprovementOne aim is to get Quality to support continuous im-

provement that is another thing the FDA and the ISO auditor will be looking for. As you perform the risk analysis, prioritize according to the impact of each. Select those



issues to work on first that have major impact to prod-uct or patient. Within the CAPA program, CAPA will not be effective unless you have a solid root cause analysis program. You need to understand and identify what were those causes. It may be more than one cause that pro-duced the problem. Once you have identified those things, you can analyze and you can appropriately determine what the corrective actions should be.

Another major issue from a regulatory perspective is that we should be learning from the CAPA issues that arise. We should be learning from our mistakes. We should be using those things that continuously failed and that were monitored to see whether there was a trend. Then we should follow through to see if we have actually improved a process or procedure as the result of doing a review or are we using a Band-Aid approach type system?

Procedural ImperativesFDA will be looking to see how we collect information,

how we analyze information, how we identify what we are going to look at, how we identify when we will be investi-gating or not, and the kinds of quality problems we plan to look at. They will investigate whether we are looking at all the quality inputs we are supposed to be looking at. All our discoveries should be documented. They will be looking at our procedures to discover whether we have objective evidence to show that the system is working, that we are, in fact, identifying the recurring issues from a practical perspective, and that from a reactive perspective, we have identified the corrective actions.

Why include Risk Analysis in CAPA Programs?

FDA agrees that the degree of corrective and preventive action taken to eliminate or minimize actual or potential nonconformities must be appropriate to the magnitude of the problem and commensurate with the risks encoun-tered.

Risk-based Decision MakingWe should also look at the risk-based approach to

CAPA. Issues in the Quality System must be evaluated from an impact perspective, from a risk-based approach. Analyze the high-risk items before we begin working on the low-risk items, because of the impact they may have on the product or on patients. A risk-based approach will give a sense of order - a method of prioritization - to the way in which you handle issues. This is especially helpful if there is a high-risk item, specifically because you may have product, process, or patient-related criticality. Ex-amine the system through internal auditing to understand whether the system is working or not.

PREVENTIVE ACTIONAs observed from inspections on the pharmaceutical

and on the device side, FDA typically categorizes the CAPA system into a three concept system: 1) remedial corrections, 2) corrective actions, and 3) preventive ac-tions. (See Figure 2.) The first item, remedial corrections, prevents the problem from getting bigger. The root cause analysis determines what went wrong in the system. The investigation determines the cause or causes so that cor-

Figure 2Three Major Concepts

Correction refers to repair, rework, or adjustment and

relates to the disposition of an existing nonconformity

Correction Corrective Action Preventive Action

Corrective Action relates to the elimination of the causes of an existing nonconformity, defect, or other undesirable situation in order to prevent

recurrence

Preventive Action is taken to eliminate the cause of a potential nonconformity,

defect, or other undesirable situation, in order to prevent oc-

currence



rective actions can be implemented to effectively prevent recurrence. Root cause analysis, and the identification of corrective action to prevent recurrence is for corrective action. From a preventive action standpoint, you must consider taking corrective action and implementing it in other systems where problems have not yet occurred, so you prevent those problems from ever occurring, thus, preventing that initial occurrence. That is the difference be-tween corrective and preventive action. Corrective action deals with preventing recurrence of the event or some-thing that has already failed. Preventive action deals with averting an initial occurrence. Things have not failed yet. You are thus, being proactive and taking steps to avoid possible future failure.

In looking at preventive action, we want to make sure that our dealings remain proactive. Preventive action is focusing on things that have not yet failed; it is planning and implementing programs for installation in the com-pany that ensure that we identify issues that could become problems, but are not currently in that category.

Programs that we typically have in place from a pre-ventive action perspective include training courses, for example. When we first hire people and we train folks, we are not training to prevent them from a mistake that they previously made, nor do we wish to prevent them from making another mistake, or problem, in production. They have never been in production. We are being proactive. Likewise, when you perform preventive maintenance on equipment, you are not waiting for the equipment to fail; you are working on a proactive basis and preventing that equipment from failing before the fact. There are many other things done in a company that are preventive in form and not reactive.

Verify Effectiveness How do we evaluate the effectiveness of an action

plan? Whether our activities are preventive or corrective, we want to make sure that we monitor the effectiveness of the time we spend performing them. Look at your cor-rective actions. What is the corrective action plan? Who is going to monitor whether the change, in fact, worked? Are they going to monitor a piece of equipment over time? Are they going to monitor an employees performance over time? Define how you will monitor effectiveness, whether it is going to be over a period of time, during the next audit or the next time you look at the system.

Specifically define how you are going to be completing the monitoring. Document what is to be done. Document how you will evaluate whether the corrective action plan actually works. Then communicate these activities to the responsible folks who have to implement them. Tell man-agement that the actions worked. You have dealt with the problem effectively and you have prevented this issue from recurring. Because of the monitoring and verification you performed, you now have documented evidence of your successful activities.

Proactive FocusFrom a preventive action point-of-view, the Agency will

look to see whether you are considering proactive preven-tive actions. They will ask you, or other representatives of the company, what activities the company is involved in from a preventive action standpoint. Be prepared to respond. Think about some of the analyses that you do. For example, a simple tool most of us use involves statisti-cal techniques. Sometimes we use SPC charts to moni-tor progress, process, or process controls. That is part of preventive, proactive thinking. When we use statistical techniques we are planning on not failing. We are looking at trends and shifts in the production environment, which is another way of looking at preventive planning that can be identified and monitored over time.

In these matters as well, we need to communicate to the folks that are responsible. Sometimes the important infor-mation does not get to management and when manage-ment has to react to a problem, they are not even aware that there is a problem. Management needs to be aware of these issues, so they can effectively deal with quality, product, and process issues to prevent them from recur-ring. They need us to keep them informed.

Learning from Prior FailuresOnce we begin applying what we learn each time we fail,

we should begin to see continuous improvement. In any Quality System, we must continually look at how we will improve as a result of the lessons we have learned from our corrective actions. As we learn from these changes, the problems will disappear. If the same issues recur, and we take the same corrective Band-Aid approaches, then we are not improving. If this happens, we will be in con-stant firefighting mode.

When we strive for continuous improvement, we con-



centrate on those efforts that have resulted from corrective actions and from our audits. We learn from our mistakes. In the process of continuous improvement, we must in-clude risk assessment. That is one thing that both the U.S. FDA and the European agencies are looking for. To imple-ment risk management approaches into the evaluation of failures includes determining whether the failures are so critical that they could have patient or product impact. If patient or product implications could be a factor, raise the question; find out what is being done, on a timely basis, to address those things that are most critical.

Considering CriticalityInspectors want to have the assurance that we, as

companies that manufacture medical devices and phar-maceutical products, understand that if we have issues in production that we will perform risk assessments to un-derstand and prevent failures from occurring again. They want to know that we can tell the difference between and are willing make the judgments that indicate critical from non-critical issues. It is the consideration of the impact, the criticality and severity of these facts that may have an impact on the patient or product that is one of the chief concerns of Agency Inspectors.

REFERENCES

1. U.S. FDA CDRH, Subchapter H - Medical Devices, 21 CFR Part 820, Quality System Regulation, Subpart J-Corrective and Preventive Action 820.100.

2. U.S. FDA, Guide to Inspections of Quality Systems Quality Systems Inspection Technique (QSIT) 1999.

3. U.S. FDA, Draft Guidance: Quality Systems Approach for Phar-maceutical Current Good Manufacturing Practices, Septem-ber 2004.

ABOUT THE PRESENTERMs. Rodriguez has over 20 years experience in all facets of

Quality Assurance and Regulatory Compliance and is cur-

rently the President of Monarch Quality Systems Solutions,

a consulting firm located in New Jersey. She has published

numerous compliance and validation related articles and has

been an industry speaker and presenter on compliance topics

worldwide including FDA workshops. She has worked closely

with CDRHs, FDA HACCP team for both the promotion of

Risk Management and the training of over 1000 individuals.

Ms. Rodriguez has specialized in International and U.S. regula-

tions, which define all aspects of Quality System Implementa-

tion and Auditing (FDA QSR/GMP, ISO 9001/13485, 21 CFR

Parts 210 & 211, Part 820 and Part 11, cGMPs for the Medical

Device and Pharmaceutical Industry). Her extensive knowledge

of Compliance Inspections, FDA-483s, Warning Letters, Part 11

Electronic Records & Signature, and Documentation Systems,

as well as Lean Manufacturing and Six-sigma initiatives provide

her with a well rounded knowledge base. She has implemented

such systems at several U.S., Mexican, and South American

companies. Jackelyn can be reached by telephone at (856)

810-3780 or by email at: [email protected].

Article Acronym Listing APR Annual Product Review

CAPA Corrective And Preventive Action

CGMP Current Good Manufacturing Practice

FDA Food and Drug Administration

FMECA Failure Modes, Effects, and Criticality Analysis

FTA Fault Tree Analysis

ISO International Organization for Standardization

MDR Medical Device Record

QSIT Quality System Inspection Training

SOP Standard Operating Procedure

SPC Statistical Process Control

U.S. United States


Originally published in the May. 2007 The Journal of Validation

when systems fail, capa validation begins

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