Water Conditioning & Purification Magazine

Changes To Certified Products and Components

By Mark T. Unger, CWS-VI

Introduction

Manufacturers are searching for ways to lower costs and increase profits. One of the ways this can be accomplished is by utilizing the highest quality materials or components without spending an exorbitant amount of money. Manufacturers and suppliers may be tempted to change materials or components based reducing production and operating costs. Changes can save manufacturers money, but in the case of manufacturers with certified products, changes can also cause them to spend money. Sometimes there’s more to look at than just the bottom line.

For companies who offer drinking water treatment units, components, chemicals, or other products certified by an American National Standards Institute (ANSI) or Standards Council of Canada (SCC) accredited product certifier (such the Water Quality Association {WQA}, NSF International {NSF}, Underwriters Laboratories {UL}, Canadian Standards Association {CSA}, etc.) making a change to a certified product may require additional testing and changes to the product’s literature or packaging. The ultimate goal of the certifiers is to maintain public health and safety, so when changes are proposed to a product bearing a certifier’s mark, the certifier must ensure that public health and safety are not compromised by the change.

Manufacturers or assemblers of certified products are required to obtain approval by the certification body (CB) prior to making a change to a certified product. The CB must review the proposed change and determine whether it will affect the certification. If it is determined that it will not, the change is often quickly accepted by the CB and no further action is required. However, if the change is determined to affect certification, the CB specifies exactly what is needed to maintain certification of this product if this change is made. The manufacturer or assembler must then decide whether they wish to proceed with the proposed change.

Each CB has its own polices and procedures for reviewing changes to certified products, but all must ensure that each change accepted for a certified product has been justified as meeting the requirements of the standard the product is certified to and that public health and safety is upheld. There are four main areas a CB must review to ensure the change does not affect the product’s certification. Some changes require action in each area, while others may only require action in one or two areas.

1) Materials Safety

For drinking water treatment units and components, each manufacturer or assembler is required to submit a current list of the materials and components that come in contact with drinking water. This list is commonly referred to as a wetted parts list, but may be identified in a different manner. For drinking water treatment chemicals, each manufacturer is required to submit the current formulation of the certified chemical. The CB utilizes the current wetted parts list and/or formulation to conduct facility assessments of the manufacturer or assembler to ensure the exact product that was tested by the CB is being produced or assembled by the certified company.

Changes to ingredients, materials or components on the wetted parts list or formulation typically require a toxicologist’s review to determine whether the change will affect the material safety of a certified product. Depending on the nature of the change, the toxicologist may recommend approving the change without additional testing, suggest limited or partial materials extraction testing, or recommend complete materials extraction testing on the certified product. Often times, complete materials extraction testing can be avoided by changing to materials or components that are currently certified.

2) Structural integrity

For changes to products and components certified to the drinking water treatment unit standards for use with a pressurized inlet, the CB must determine whether the proposed change to a material or component will require additional structural integrity testing. Changes to pressure bearing components such as tanks, valves, tubing, filter housings, o-rings, faucets, etc., typically require structural integrity testing to ensure the proposed change does not compromise the product’s structural integrity. Once the structural integrity of the product has been verified, the change can be approved.

3) Product performance

Changes to certified products must also be reviewed to ensure they do not affect the performance of the product. The performance claims of systems vary by water treatment device, but typical claims include chemical reduction, mechanical reduction, pressure drop (for point of entry units), minimum/rated service flow rate, daily production rate (RO and distiller), efficiency and recovery (RO). There are a few obvious changes that would require testing to verify whether a change to a certified should be allowed. For example, changing RO membranes, filter cartridges, or media would require testing to show the change does not cause the product to perform below the requirements of the industry standard it is certified to. However, a simple change of an o-ring or filter housing may be perceived as not having an effect on the performance of a certified system. As you may have already guessed, these changes could affect a system’s performance. This type of change may affect the seal between the filter housing and filter cartridge, which could allow an o-ring bypass to occur. Typically, testing the product with the proposed change for a mechanical filtration claim, such as particulate or cyst, would give adequate proof that o-ring bypass is not occurring. However, depending on the claims a certified product is making, additional tests may be required to ensure no less than equivalent performance occurs with the unit with the proposed change.

The results of testing a changed product are compared to the test results generated prior to the proposed change to ensure the changed product does not perform below the previously tested unit. There are four different outcomes that could occur from this testing – 1) the product outperforms the originally tested unit, 2) the product performs exactly the same as the originally tested unit, 3) the product performs worse than the originally tested unit, but still meets the requirements of the standard, or 4) the product does not meet the requirements of the standard. Only the fourth outcome would result in the rejection of a change, since the performance of the product was adversely affected. The other outcomes would either be accepted or accepted with changes to the product literature.

4) Product packaging and literature

When a change is made to a certified product, the product’s literature and packaging must be reviewed to determine whether a revision is necessary to reflect that change. Literature or packaging referencing specific components may need to be revised if they are being changed. Most often, literature and packaging would be revised for the actual performance of the product.

If the CB requires re-testing of a product with a proposed change and the system outperforms the originally tested unit, then the manufacturer or assembler has the option of either changing their literature to show the improved performance or to leave the literature as is listing the original test data. Most manufacturers will wait until their literature is being re-printed before making a change in this case.

If the CB requires re-testing of a product with a proposed change and the system performs below the originally tested unit but still meets the requirements of the standard, then the manufacturer or assembler must either change their literature to reflect the decreased performance or drop the request to change the certified product. In this case, the manufacturer must provide the revised literature prior to the acceptance of the change by the CB.

Audits of manufacturers and assemblers

Once approved by the CB, the changes made to a certified product are verified through an audit of the customer’s facility. The auditor compares the revised wetted parts list or formulation to what is actually being produced or assembled to ensure that the correct ingredients, materials and/or components are used.

Plan ahead – add alternate suppliers

Often, customers will include alternate suppliers on their wetted parts lists or formulations at the initiation of the certification process. The CB takes these alternate suppliers into consideration when the original testing plan is prescribed, so that all testing conducted will include the use of alternate suppliers. This option may require additional testing, which can slightly increase the time to complete certification, but in the long run it saves the customer from being locked into to one supplier. Having approved alternate suppliers gives the manufacturer or assembler the flexibility to change suppliers without having to go through the formal process of changing a certified product.

Closing

Many people dislike change, but we’re all required to make changes at some point in our lives. Some changes can be for the better, but some changes leave us in a state of regret. It’s ultimately up to the manufacturer or supplier of a certified product to decide whether a change to their product is in the best interest of their company, but the Certification Bodies ensure that the change to the certified product is in the best interest of the end user or consumer. To have reputable certification programs each certifier must ensure that all products meet the requirements of the standards they are certified to as well as maintain public health and safety.

About the author

Mark T. Unger, CWS-VI is the WQA Technical Manager. Reach him at WQA, 4151 Naperville Road, Lisle, IL 60532-1088; telephone 630 505 01260; fax 630 505-9637 or via email, munger@wqa.org.

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