Welcome to Launsby Consulting’s Plastic Process Validation Course. Process Validation is a requirement of the Good Manufacturing Practice Regulations and is applicable to Injection Molders that manufacture medical devices. This course discusses Process Validation elements and concepts that are not only consistent with FDA compliance but also make good business sense. Click on the arrows above to learn more about validating plastic processes.

Although the FDA does not technically require validation, they strongly recommend it. The FDA likes to see that validation is part of your design history and design controls. Regardless of FDA requirements, validation makes good business sense. Inspecting for quality cost money. It is best to design quality into your product from the beginning.

During an audit, the FDA will often start with customer complaints and work back through the process. They now get into the design history. If the problem occurs in the field, the FDA will go back through all the production records at the OEM and see how the OEM investigated the issue. The FDA can also investigate process falilures that never got into the field. This is a fairly new approach within the last couple of years. The FDA can actually look at defects that didn't leave the OEM's building. This is where you really need to have control over how the defects were handled. This is where process validation comes in. Ideally, you would like to prevent these defects from ever happening again.

Suppose a problem is found on the floor during manufacturing. The Corrective Action is solving the immediate problem. Initially, the product is "identified" such that none of the substandard product ever leaves the facility. Controls will then be put into place to make sure that substandard product is never produced again. Preventive actions are of a more proactive measure. They do not wait for the problem to occur. Once the problem is found it is too late for preventive action.

Failure Mode, Effects and Criticality Analysis or FMECA is a methodology designed to identify potential failure modes for a product or process. The risk associated with those failure modes is assessed. The FMECA is then used to rank the possible causes of failures in terms of importance and to identify and carry out preventive actions. In a validation, be sure and check those things that matter most to the customer. The FDA is also interested in knowing that you have control over what the supplier is manufacturing. Suppose a supplier furnishes a mold register that can affect an FMEA item. The FDA will make sure that the OEM is controlling that supplier to ensure they are producing quality mold registers.

This is a slide from an older version of the Global Harmonization Task Force document on process validation. That document was an attempt to bring together all the different validation requirements of all the different regulatory bodies around the world. The FDA had a big hand in drafting the document and they actually use many of the concepts discussed in it. According to this older document, several questions needed to be answered. "Is the process output fully verifiable?" If yes -"Is the verification sufficient and cost effective?" If yes - verify and control the process. If the answer to question A or B is no, "What is the level of risk to the user?" If the risk is low you could accept the risk and verify and control the process. If the risk to the end user was high, you had to validate the process or redesign the product and or process. Go to the next page to see the latest version of this flow chart.

In the new version, the Level of Risk to the customer section is gone. In this new document, you must be able to prove that the process output is fully verifiable in order to not validate. This is difficult. Verification is confirmation by examination and provision of objective evidence that the specified requirements have been fulfilled.

Here is an example of a process that cannot be verified so it must be validated. It is impossible to 100% verify that a fuse is working because you would need to destroy the product. Fuse manufacturing is an example of a process that must be validated.

Here is a partial list of processes that must be validated.

Let's start with the basics of validation. Process Validation is a term used to indicate that a process has been subject to such scrutiny that the result of the process (a product, a service or other outcome) can be practically guaranteed. There are many things that go into Process Validation. Validation really begins with the design, going all the way back into early Research and Development. It is important to use a cross- functional approach. Failure Mode and Effects Analysis (FMEA), Design of Experiments (DOE), Statistical Process Control (SPC) all play vital roles in process validation.

Material Selection is important. Is the material appropriate for the product? Usually R&D takes care of this but they may not understand the subtleties of manufacturing. For example, R&D may have access to a material but it cannot be obtained "long term".

Another consideration is: "What are the critical dimensions?" A molded part can have hundreds and sometimes thousands of dimensions. It is important to know which dimensions are important and must be held to tight tolerances. This needs to be decided up-front. An example would be peristaltic pumps. The pump headers are made of tubing. Is the ID and wall thickness more important or the OD and wall thickness? In a pump application, the ID is typically more important because the stroke volume of the pump is dependent on the ID. In other applications such as bonding to the outside of the tubing or where the tubing has to fit into a certain hole, the OD is more important. Determining critical dimensions up-front is extremely important for Process Validation.

One of the keys to being successful at Process Validation is following a team approach. It is important to get Engineering, Manufacturing, R&D, and Quality Assurance together. Marketing should also be involved as the "voice of the customer". Material and Equipment suppliers should provide input as early as possible in the process to avoid "surprises" later. It is imperative to form multifunctional teams for validation success.This team should now define the requirements of the validation. FMECA is one tool to help with this process. Decide on the desired outputs. These are typically the customer requirements or certain dimensions that have to be met. Finally, develop a Master Validation Plan so that all goals and objectives are clearly defined and agreed upon from the beginning.

One of the first things the FDA looks at when they perform an audit is how a company accepts their raw material. Often OEMs will sample and inspect incoming raw materials. This may include visual inspection, physical testing or both. Most OEM's also look at a Certificate of Conformance. When reviewing this certificate, it is important to fully understand the following: What does this actually certify? Conformance to what? What specifications are listed? Whose are they? Does it reference percentage of regrind? Does it contain test results? Some of these tests might include impact tests, molecular weight distribution, gel permeation, chromatography, tensile tests...the list goes on and on. The key is to make sure that the tests actually have something to do with your product. Sometimes people will misuse the standardized test just so they have something on their paper work even when it has nothing to do with the real requirements of the material for their particular process. For example, if you are testing tensile strength and are accepting material based on a tensile property, make sure there is a correlation between tensile strength of the material and a property of your product.

Here is a sample material callout that might be on a drawing. Section A discusses the percent regrind allowed for that material. Section B shows that the lot number traceability must be marked on the package with each shipment of parts. Section C deals with the shift and manufacture date. This must be specified when receiving product from a custom injection molder. Section D defines that "for medical use" to be tested at a specific facility. Typically OEM's do not accept a resin manufacturer's toxicity results. Due to the negative "exposure" should the material be toxic, the OEM will repeat that testing themselves. Some companies believe that if the product is going to be in contact with blood, there should be no regrind. This is not really based upon science. The regrind is not necessarily bad if you have good traceablity. Of course, technically, the only percentages you can definitely "trace" or 0% and 100%.Bottom line: A material callout is not just a fancy document to impress the FDA. Make sure you are actually checking all the items discussed in this callout and can show the FDA that you have done so.

Let's talk about the mechanics of process validation. The first thing needed is the Process Validation Protocol. There is no magic involved in this. Simply write down what you are going to do. This helps keep you on track. In the protocol, identify the scope of what you are trying to do. When a complex medical device is manufactured, there are a lot of different processes that go into it. You are not going to validate it all at once. Instead, you will validate a subset of those processes. This can even get into the level of shift and operator. Identify this scope upfront. Next identify the input requirements. What is acceptable from suppliers for raw material. What is acceptable for subassemblies? What constitutes passing and what constitutes failure? Next identify the outputs and how they are going to be measured? What will be measured as acceptance of this process validation. The next step is to determine when revalidation will occur. The FDA also wants to see Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). These are discussed later in this course.

The purpose of Installation Qualification is to ensure that the production system is installed as designed prior to any subsequent validation. Basically, did you put the thing together right.

The first thing to check is that the equipment is installed correctly. Often the equipment is installed by subcontractors who may not understand the design requirements. Close checks are required to ensure that equipment will function correctly. Consider an actual example of a sterilization facility where things went terribly wrong. This facility was built by a subcontractor and they used the wrong grade of stainless steel piping in the system. This sterilization process had miles and miles of stainless steel piping and the improper piping wasn't caught until the plant was going up for validation. It cost the company millions of dollars to rip out the old piping and replace it with the proper grade of piping. This could have all been avoided if the company had paid attention to their own specifications for the piping.

Remember, the developer of this course actually trains the FDA in Injection Molding Validation. One of the biggest problems is that manufacturers do not spend enough time on Installation Qualification and thus their Process Validation is doomed to fail. Here is a partial list of things to check. Is the line voltage correct? Is the machine level? Does it need a special foundation? Some presses require 12-inch thick foundations and double reinforced concrete. Is there enough water flowing to ensure proper machine cooling? Environmental Controls are also important. Is the room temperature and humidity properly controlled? If manufacturing occurs in a clean room, are all clean room specifications met? Were tool specifications actually met? A lot of time is spent specifying how a mold should be built and it is important to verify that they were actually built to these specifications. There should be a written document showing that the tool was checked. Calibration is another important thing to check. Calibration of pumps and temperature sensors are just two examples of things that might be calibrated on an injection molding machine.

Consider a process that required 110 psi air pressure but at certain times of the day would start to have a lot of failures. Even though the air was being regulated down to another pressure and no pressure variations were seen at the machine, failures were occurring at certain times of the day. When the engineers traced back, they found that it wasn't a problem with the air pressure, it was a problem with the volume that could be delivered by the system. There was another machine in a totally different part of the building that was causing the problem. Whenever this other machine was turned on, the air pressure "sagged" just enough to take so much volume that the original machine couldn't keep up. This illustrates that it is not enough to check that a utility requirement is correct at a specific time but that it is consistent at all times.

Let's discuss calibration in a little more detail. Why is calibration important? Basically, it draws a line in the sand. It documents exactly how the equipment was running from the start. If anything ever happens to the process, you will know what it was when it started. Consider a process requiring an injection rate of 4 inches per seconds. A control valve is changed and the equipment seems to be injecting at a faster rate. If no calibration was done initially, it would be impossible to determine if it really is injecting at a faster rate with the new control valve. Most modern machines are solid state and difficult to calibrate in house so the actual manufacturer does the calibration. Make sure the manufacturer provides detailed documentation regarding the calibration of their equipment.

There are other things that need to be checked. It is important to know any building codes that might affect the installation of your equipment. Are there specific codes you must follow in order to sell to another country? Do all incoming materials meet specification? Does the equipment adhere to the design specifications? Are there sufficient spare parts and are those spare parts validated? Suppose you need to replace a core pin on a mold. It is important to know that the spare meets the dimensions and is actually made to the same specifications as the original part. If a subassembly is received from a supplier, make sure the supplier has done their homework and validated their process. The supplier should be required to provide documentation that their process is validated and consistent. Finally, make sure all the preventive maintenance procedures for the machine are complete. Having PMs done before you start the validation can save a lot of hassle down the road. It's a really bad idea to start a validation on ultrasonic welding when the machine has a bad air regulator. Do the Preventive Maintenance first, replace the bad air regulator, and then perform the validation. This may sound like common sense but you would be surprised at the number of companies that begin validation before performing preventive maintenance checks.

An Installation Qualification should also check the support equipment. Consider the strip used on a glucometer. A company can have the best glucometer in the world and if the test strip is cut so it doesn't fit into the meter, a person can not measure their blood sugar. The machine used to cut this strip is very important.

This is a cooling system for an injection molding facility. During the Installation Qualification, all of the gauges should be checked. It may not initially be known exactly what the gauges should read. What is known is that the pumps at the press need a certain input pressure and a certain volume of water. The input pressure and volume of water can be measured. Once those measurements are recorded, note the readings on the gauges. This is all documented at the start of the validation process. That way, if things change, one can go back and either fix it or revalidate it. Bottom line: Documentation should exist such that the process could be duplicated by just following the documentation. The documentation should clearly define where everything was when the original validation was done.

A lot of materials need drying to ensure the product quality. PETG is one of those materials. If it doesn't get dry, there won't be any visual indication that the material isn't dry (splay or haze on the part). The PETG will just crack. Everything will look fine, everything will look beautiful, but everything will become brittle and fail. This example illustrates how important it is to verify that the dryers are functioning properly.

This is an automotive part from a multi-cavity tool. The part is approximately 4 inches wide and 2.5 inches high. This happens to be a safety-critical part in your car. When R&D ran the part, it looked good. All four cavities measured within specification. The problems began in production. The first production run had parts all over the place. The parts varied by 25 thousandths of an inch from cavity to cavity. The spec was +/- 5 thousandths of an inch.The process engineers were blaming tooling. A pair of dial calipers promptly showed that all four cavities measured the same. The tooling engineers were blaming the process engineers. Then they all got together and decided to blame the material. However, the material was polypropylene which is very easy to run.

Finally, someone decided to check the cooling system. This is how production had it setup. All four inputs came in at the top, looped around and exited from the bottom.

This picture shows the solution to their problem. They changed the setup of the lines to exactly the way they were setup for R&D and the variation from cavity to cavity was reduced to within specification limits. This problem had been costing the company a lot of money. The problem would have never occurred if a proper IQ had been performed. One setup document in their IQ or even a photograph of the way the tool was setup in R&D would have saved the company a whole lot of money. This is why the IQ is so important. It defines where you were when the validation was started. It draws a line in the sand. If necessary, it allows you to get back to exactly how things were when you started this process.

Here is an example of a water setup sheet for a mold that has a large number of zones. Manifold positions are defined. They are also marked and stamped on the tool. Some tools have a manifold bolted onto the tool so there is only one connection and it cannot be plumbed incorrectly.

First Article Inspection involves checking EVERY dimension and attribute of a part made on the exact machine which will be used for production of the parts. This is usually not the very first piece off the machine. Usually it is the first piece once the machine has been tweaked but before actual production is authorized. The FDA will look to see if they are performed. If they are performed, how are they reported? How are failures handled? If you picture an injection molding tool, there are numerous dimensions. Some of those dimensions will not meet exact specifications. As long as they are not a critical dimension and they do not affect the design intent of the product, this is not a problem. Remember, this is why critical dimensions are defined upfront. For non-critical dimensions, it is common practice to adjust the print to match the first article. It is recommended that you do not adjust the nominal on the print. It is better to adjust the tolerances. That way you never lose the original designer intent. If the original designer intended for a dimension to be 1.000 inches and the First Article shows it at 1.005, set the tolerance such that 1.005 is included as being acceptable. Leave 1.000 as the nominal even if you have to make the tolerance lopsided.

Another aspect to First Article inspection is the cavity to cavity variation in multi-cavity tools. Are the cavities identified? If repairs are made, are the first articles repeated? Suppose a core pin breaks and needs to be replaced. It is typically not necessary to repeat the first article for the whole tool. It is necessary to first article the dimensions that are made by that core pin. Another way to handle it is the following: When the original tool is made, all the spares are measured to make sure they are all identical. If they are identical, the first article will not need to be repeated. A lot of determining whether to repeat the first article inspection depends on your engineering knowledge of the product and tool. Will the change affect the product purpose or quality? What about if a cavity is replaced in a multi-cavity tool? Does it get the same cavity number as the one it replaced? Again, this is a judgment call. If cavity three is replaced, does it get replaced with another one marked three or does it get an entirely new number? If cavities are blocked, what actions are performed? Does the customer get notified? Do you revalidate the process again? The main thing is to document everything clearly and precisely.

First Article Inspection is important as illustrated by "The Case of the Missing Cavity". An OEM suddenly had problems assembling some components. They happened to be ultrasonically welded together. The parts still fit well together but they were causing some functional failures. As fate would have it, there was a very delicate piece inside that got welded. If too much energy was put into the weld, it would destroy this delicate piece. The OEM contacted the molder and discovered that one cavity in an 8 cavity mold was missing. The molder said there were flash issues on that cavity so they decided to block it. This was an insignificant flash problem that did not affect part functionality. Instead of asking for the print to be changed, the molder blocked the cavity and adjusted the shot size by 12 percent. By doing this, they affected the pressure variation through the cavity and the pressure dropped through all the cavities in the mold. Remember high school physics? The speed of sound through a solid is related to the density of a solid. When the pack pressure is changed, the density of all the cavities changes. The density change affects the way the part ultrasonically welds. It required more energy to weld which caused the delicate part to be destroyed. Bottom line: This could have all been avoided if proper validation procedures had been followed.

Installation Qualification is now complete. We have established and documented that process equipment and ancillary systems are setup correctly. What do we do next? The next step is Operational Qualification. The purpose of Operational Qualification is the following: to verify proper equipment operation and safety. to define the key processing parameters and their associated ranges, and to demonstrate by objective evidence that the process will produce acceptable results under anticipated manufacturing conditions.Verifying proper equipment operation and safety blends in with Installation Qualification and Performance Qualification. Operational Qualification is the heart of validation.

It is now time to define the key processing parameters. In molding, the traditional method is to find a process, guess, set up a window and guess again. The "expert" comes in, does their magic, sets the windows and leaves. This only works if you are really good at guessing. A better method is to learn how the tool processes by systematic methods. For example, look at how dimensions are affected by different factors. Use Design of Experiments (DOE). Design of Experiments is a essential tool for validation. DOE is a method that involves systematic controlled changes of the inputs or factors to a process in order to observe corresponding changes in the outputs or responses. By understanding these relationships, molders can then define meaningful windows for their process.

What does Design of Experiments tell you? It can tell you how close you are to your specifications. It can provide an estimate of Cpk which relates to the standard deviation of the process.It can tell you how big your window is and where your process lies within it.

Not all parameters will be tested in a DOE. A molding machine often has 25 pages of set up. Typically only 4-5 factors are actually varied in the DOE. Suppose the purpose of the experiment is to figure out how to minimize shrinkage. Engineering knowledge suggests that Fill Time, Pack Pressure, Pack Time and Cooling Time all have a influence on shrinkage. The settings for these factors will be changed during the experiment. Engineering knowledge suggests that there are many factors that do not have an influence on shrinkage. These factors are held constant throughout the experiment. It is still important to document the "constant factor" settings in an experiment.

If the measurement device used to measure the part is inaccurate or unstable, the measurement system will introduce so much variation that the experiment will fail. Many medical devices use soft vinyl parts. One molder used calipers to measure these soft vinyl parts. A Gage R&R study showed that the measurement device was not repeatable. Each operator would put a different amount of pressure on the calipers, thus deforming the part. This caused inconsistent readings and thus introduced a lot of error just in the measurement. This company designed a custom gauge that does not distort the part. The measurement repeatability was improved so that the gauge always measured consistently.

Gage Repeatability and Reproducibility studies allow one to estimate the contribution of variation attributable to the measurement system itself. If this study indicates that the measurement system is not reliable, the system should be fixed before running any experimental designs.

Once the measurement device has been verified, design of experiments is a critical tool for validation. If performed correctly, the DOE will yield an equation defining the process for each of the responses in terms of each of the factors. An actual equation will be generated to model the molding process. Using that equation, you will know how a change in a factor level will affect your response. If you change the Mold Temperature, you will now have a model to know how that change will affect part dimension.

Here is a Response Surface graph. This came from software specifically written for Design of Experiments. The software used the model generated from the DOE and produced this graph. By looking at the graph, you can see how burst is affected by changes in the settings for Temperature, Dwell Time and Pressure. To maximize burst, we would set the pressure at 88 psi, temperature at 334 degrees and dwell time to 2 seconds.

Design of Experiments is an excellent tool to use during the validation process. DOE is easy to learn and easy to use. Specific courses exist that will help you learn this valuable tool. Launsby Consulting offers in-house training, public seminars and on-line training courses. Software has been developed to help with the analysis of experimental data. DOE is also very cost effective. Many companies have saved hundreds of thousands of dollars through the use of experimental design techniques.

The FDA is also instructed to look for Functional Testing in the Operational Qualification section of the validation. This is testing to verify that the parts work for the intended application. For example, tubing in a medical device may undergo flex life testing or an accelerated aging test to make sure that the tubing is not going to fail under expected use conditions. Syringe manufacturers should verify syringe volume. Sometimes no actual testing is involved. If certain dimensions are met, design history indicates that the part will function correctly.

What tests should be performed? The FDA expects companies to look at their Failure Mode Effects and Criticality Analysis. What are the critical characteristics of the product? If there is something in the FMECA that indicates certain conditions will cause a part to fail or cause a patient to be harmed, the Operational Qualification must test for this. For example, a FMECA indicates that a bond void or hole in the set of an infusion pump could cause air to be drawn into the set. This would cause infusion of air into the patient. Testing should be done to duplicate the conditions where that would happen. Steps must be taken to insure that the process used to manufacture the infusion pump would never produce these conditions.

What does the customer need? If there is a need for a defibrillator to deliver a certain current and voltage, verify that it can actually deliver that current and voltage. What poses the biggest risk? If the current and voltage is too high, it could kill the patient. This should be designed out of the process to make sure the patient actually cannot be harmed by the defibrillator.

Operational Qualification is the time to find the limits of your process. Define how variations in inputs or factors will affect the outputs or responses. Design of Experiments is one way to do this. Look at how a subassembly operation will affect later operations. Explore the windows of the injection molding process and take samples from those different windows. Perhaps you can start with a DOE on a subassembly then feed those results into another DOE on a process step further down the line.

Perform fault checks. If there is a fault in the system, make sure the fail safe works. Fail safes must be in place so automated equipment that produces thousands of parts per hour does not produce thousands of scrap parts per hour. Make sure that automated equipment will alarm if something is out of specification. Make sure that any automated measurements will alarm if an out of spec condition is found. Verify that equipment is maintaining set point. This is especially important on injection molding machines. Injection velocity may have been set correctly at the start of the shift but does it drift during the shift? Often cooling systems simply can't keep up with the heat that is being added to the mold. Make sure checks are in place to ensure that the cooling system runs consistently.

Some less obvious things to check would be: Operator training - document all operator training. Make sure all operators are trained to run the process properly. Raw Material Specifications - make sure the specifications are meaningful. Specify what is really needed for the product. Fault injection and Process Challenges - basically, try to "break the system" but in a controlled manner.

Consider a validation on an ultrasonic welding operation. When the engineers ran the process on first shift only, there were no problems. During Performance Qualification, product was produced on both first and second shifts. The first shift parts were fine.The pull strength on the welds was around 25 pounds. On second shift, they started to run into problems. The pull strength went down to only 5 pounds. It turns out the welder was overheating and this overheating degraded the performance of the weld. This is something that would have never been found in Operational Qualification because OQ doesn't run the process for a long period of time. Once it was discovered, alarms were put in place to notify operators if a welder was overheating.

Really, in English, the purpose of Performance Qualification is to make sure the process will continue to run over time. Make sure controls are in place so that any process variation that might affect product quality will be caught. Verify that all systems will work long term.

Consider a validation on an ultrasonic welding operation. When the engineers ran the process on first shift only, there were no problems. During Performance Qualification, product was produced on both first and second shifts. The first shift parts were fine.The pull strength on the welds was around 25 pounds. On second shift, they started to run into problems. The pull strength went down to only 5 pounds. It turns out the welder was overheating and this overheating degraded the performance of the weld. This is something that would have never been found in Operational Qualification because OQ doesn't run the process for a long period of time. Once it was discovered, alarms were put in place to notify operators if a welder was overheating.

Obtain objective evidence that the process is within specification. Calculate the Cpk. Look at the distance from specification limits. Pull SPC samples to check stability over the long-term. Pull consecutive samples to verify stability from shot to shot. Collect machine data to ensure that machine settings are stable over time. For example, collect data to ensure that water temperature controllers are maintaining the temperature over time and are not drifting. Verify that the procedures are complete and easily understood. Was anything left out of the procedures? Previously, only engineers were running the process. Now operators are in charge. This is kind of like a test drive of your process. It's a time when engineers cannot touch or modify it but can see how everything they put in place plays out on the production floor.

What does Performance Qualification tell you? One of the beautiful things about PQ is it will run long enough to capture natural variation. Natural variation will happen. You want to make sure you can live with it. Functional testing will occur. Make sure the product meets the customer need. Make the process as close to production as possible. Ideally, run several 24 hour runs using all shifts. Run across as many environmental conditions as possible. Obviously, some common sense needs to be used. For some products, four hours of production may produce a years worth of product. Vary the incoming material. For example, test out the whole range of viscosities.

Being "close" to production means setting things up as close to production as it can get without actually being "production". Procedures are finalized. Inspection and quality monitoring plans are in place. No process "tweaks" will be done. Critical parameters will be monitored. Many molders don't want to perform long PQ runs because they think that all the product produced must be scraped. If you scrap all the product, it can cost a lot of money. If the work is done up-front, this does not always have to be the case. Make agreements ahead of time with your customers. Note that the PQ runs are done under very controlled conditions. They are basically production runs that carefully scrutinized. By having an agreement with customers up-front, product from the PQ runs can be sold. This can save your company a huge amount of money.

Determine Process Capability. Establish where the natural variation lies within the specification. Collect some baseline data that can be compared to the process later on. If something drifts later, baseline data exists so comparisons can be done. This draws a line in the sand from day one. It shows how the process was running initially. Xbar R charts can now be established to show when your process is out of control during production. The PQ can also reveal where improvements need to occur. If the variation is too high, this can be addressed before moving the process to production.

This is the sheet used to record the data. The FDA will pay particular attention to this inspection sheet. Amazingly, companies have been known to record that a part is out of specification but send it on anyway. This should not happen. The inspection sheet also lists gauge calibration information. Calibration due dates, the gauge used and how it was calibrated are all recorded. This documentation allows traceability. For example, if a set of calipers is bent, you can trace back to the product that was measured with those actual calipers. Only the product measured with the defective calipers would need to be scraped. This documentation can save a company time and money.

The first part of the molding setup sheet documents the purpose, scope, data storage requirements, glossary, special items and procedure.

The next part of the setup sheet shows the ranges that were determined during the Operational Qualification. It shows the range for acceptable adjustments.

This setup sheet has a caveat. The NOTE states: Settings may be adjusted within the ranges listed during the course of normal production. Note changes in the process log. Changes may be made by Engineering Technician or Designee only. Many parameters not listed above but contained in the setup screens, may be adjusted to improve the general operation of or prevent damage to the press, mold, molded parts and auxiliary equipment. These parameters include but are not limited to clamp movement, ejector plate movement, carriage movement and lubrication settings. All changes to these settings will be recorded in the process log. In other words, it is acknowledged that there are windows around certain settings but there are other settings that are not important to the product. It doesn't matter where these are set. It is extremely important to prove that a setting is not important.

Here is an example of a setup log. The purpose of this log is it verify that the process is actually running within the predefined windows for a particular run.

Where is the process set during Performance Qualification? Choose a point with a predictable response. It is probably going to be within the window established during Operational Qualification. Next verify that the response is as expected. It is not necessary to test the entire range of settings. It is only necessary to test a point within the window. It is important to have increased vigilance during this part of the test. When looking at the product, use more scrutiny than normal.

When should revalidation be done? Causes for revalidation include, but are not limited to, the following: When a change is made to the process that is going to affect the quality of the validation status. When a negative trend is observed in the quality indicators. When a new feature is added to the part that changes the process entirely. When a process is transferred from one facility to another. When a tool is being used for a new application. Suppose a machine was making a part for an implant and that product went away. Now the machine is being used to make a part for some other application. Sometimes it is not necessary to perform an IQ, OQ and PQ during revalidation. Suppose equipment was moved from one room to another. The equipment is now plugged into a different power source so it is necessary to perform an Installation Qualification. It is probably not necessary to perform another OQ and PQ. What about raw material supplier changes? It would be necessary to perform an Operational Qualification and verify that the new material does not have an impact on the processing window. If that is the case, there is no reason to repeat the entire validation. On the other hand, if the new material has a huge impact on the window, the entire validation will need to be repeated.

Let's review the validation steps. Step 1 - Assemble the Team. Step 2 - Plan the approach and define the requirements. Step 3 - Identify and describe the processes. Step 4 - Specify process parameters and desired output. Move your mouse over each step to get more details regarding that step.

Step 5 - Decide on verification and/or validation. Step 6 - Create a master validation plan. Step 7 - Select methods and tools for validation. Move your mouse over each step to get more details regarding that step.

We are now ready to create the validation protocols. Move your mouse over each type of protocol to get more details.

The next step is to perform the Installation Qualification. It is important to sign off on this qualification before performing the Operational Qualification. Next, actually perform the Operational Qualification. This must be completed, reviewed and signed off before Performance Qualification begins. In Step 11, perform the Performance Qualification. Complete, review the results and sign-off on this qualification before proceeding to Step 12. In Step 12, continuous process controls are defined. Continuous process controls are an integral part of the process validation effort.

Step 13 -Control the process. It is extremely important that companies ensure that continuous process controls are in place, that information from the controls is reviewed, and that appropriate actions are taken.

Revalidation must be completed anytime there are significant changes in packaging, formulation, equipment, processes, or product characteristics. Changes in raw material suppliers would almost always require revalidation. Statistically based control charts or other data analysis tools can be of great benefit in determining if revalidation is required. Final decisions regarding revalidation and the extent of revalidation are the responsibility of the validation review board.