Tuesday, June 24, 2008

Kosher Certification and Its Impact on Quality

We have all seen the little kosher symbols on food and supplements that we buy. You may or may not have recognized what it was, but a lot of the food we eat is Kosher certified. So, what does that mean for the consumer? What does that mean for the manufacture? The simple answer is a higher confidence in the quality of the product.

To be kosher certified by one of the big kosher agencies like OU®(circle U) or OK®(circle K) means that the manufacture is following its established cleaning procedures, Standard Operating Procedures (SOPs), and using proper identification and tracking of all kosher raw materials, in-process materials, and finished goods. It also shows that all of the manufactures procedures, practices, and facility are up to the rigid standard set by the kosher agency.

There are a couple of different types of kosher certification a company can have.
Kosher Pareve: the product has no dairy ingredients or meat/poultry ingredients in it and has not been processed on equipment that has also processed dairy ingredients or meat/poultry ingredients.
Kosher Dairy: the product either contains dairy ingredients or has been processed on equipment that has also processed dairy ingredients. This is usually designated by a ‘–D’ after the kosher symbol.
Kosher Meat: the product is Meat/Poulty. Alternatively, they may contain meat/poultry ingredients or have been processed on equipment that has also processed meat/poulty. This is usually designated by a ‘–M’ after the kosher symbol.

There are a couple of different ways a manufacture can approach kosher certification. Each has its advantages and disadvantages.
· The manufacture can product both kosher and non-kosher material in the same facility. This requires special cleaning procedures between non-kosher production runs and kosher production runs. The manufacture must clean its equipment and production rooms to a level that ensures that there is no non-kosher material residue left that could contaminate the kosher material. The Rabbi can request to inspect the equipment and room before the manufacture is allowed to produce. Depending on the level of confidence that the kosher agency and supervising Rabbi has with the manufacture, this must happen ever time the kosher product is produced, or the Rabbi can request production dates and show up for random inspections. Also, the supervising Rabbi can show up anytime for an audit of the raw material inventory and label inventory.
An advantage to this approach is that the manufacture has the flexibility to run products for both kosher and non-kosher customers. This works especially well for contract manufactures. It also allows greater flexibility in what raw materials the manufacture can use.
A disadvantage is that the manufacture must have a reliable inventory system to prevent kosher and non-kosher material and finished good mix-ups. Extra attention must be paid to raw material receiving to ensure that kosher material is received with all of the proper documents and kosher marking that are required. It also limits what type of non-kosher ingredients can be used on equipment that will run kosher material. As an example, pork products can be especially tricky to deal with. Special cleaning procedures are needed such as washing the equipment with 180° water. The inability of the manufacture to follow these procedures can lead to them not being able to use that piece of equipment for kosher production ever again.

· The manufacture produces only kosher products. This requires that all cleaning procedures and SOPs are up to the standards set by the kosher certifying agency. All raw ingredients must be on an approved ingredient list. There can be no unapproved non-kosher material is allowed in the door. Same facilities have a Rabbi on site at all times to supervise to give his blessing and watch manufacturing.
The advantage to this is that the manufacture does not need to worry about what machines he runs kosher material on or have special cleaning procedures. Since the whole facility is kosher the problems of ingredient segregation, tracking, and labeling is somewhat relaxed.
A disadvantage is that the manufacture cannot produce any non-kosher products or receive in any non-kosher material. All raw materials that are received must be kosher and anything that is not properly marked cannot be allowed inside the building.

From a manufacture’s stand point having the ability to produce kosher products gives their current and potential customers more confidence in their ability to produce a consistent, quality product. The consumer can be assured that the kosher product they are buying has been held to a higher standard of quality and control. The benefits far outweigh the extra cost when it comes to kosher certified products. By having the kosher symbol on your products it shows that you are willing to hold your products to a higher standard.

Saturday, June 7, 2008

GMP’s, Training, and Plant personnel

One of the biggest pitfalls for a dietary supplement manufacturer is not following strict GMPs. Being lax on GMPs will get you in trouble with your customers when they come to do audits and can cost you valuable business. It can also lead to serious consequences with the FDA. Product recalls and forced plant closures to fix violations can be expected if GMPs are not being followed. An FDA audit is not something that anybody wants to go through, even if you are following strict GMPs. See the links section for FDA enforcement actions taken this year.

One of the biggest challenges as Quality is getting all of the production employees to follow GMPs every day. There are a couple of approaches that should be taken together to accomplish this.
1. Train all of your employees in GMPs. This way everyone in the plant is aware of what rules they need to follow to comply with the regulations. This sounds straight forward and logical, but in practice this can get pushed to the back burner as more immediate production issues occupy your attention. The irony of this is that a lot of these issues actually stem from lax enforcement of GMPs. Train all of your quality staff in the GMPs and emphasize what to look for when they are out on the production floor. A good way to do this is to do periodic internal audits, preferably monthly or quarterly. This way all of the quality staff gets to see concrete examples of the proper way to follow the GMPs as well as any GMP violations that the audit finds. Along with this, emphasize to the quality staff that they are the examples for the rest of the plant to follow. Emphasize how important it is for them to strictly adhere to the GMPs.
2. Office staff, upper management, and owners need to strictly follow the GMPs when they are out on the production floor. If you have management or owners not following the rules then the production employees tend to think that “if the managers aren’t following the rules then I don’t have to either”. This is a very bad habit to allow to form.
3. Have quarterly GMP refresher training to reinforce how important it is to follow the regulations. Get all the employees involved in creating an atmosphere of compliance. Use incentives to encourage employees to point out deficiencies and come up with solutions. They are the ones who are working on the production floor every day. They see the deficiencies, so getting them involved will make it that much easier to comply.

There are independent GMP certifying agencies that can help your company become compliant and lend credibility to you GMP program. NSF International is one of the world leaders in independent certification.
NSF International, The Public Health and Safety Company™, a not-for-profit, non-governmental organization, is the world leader in standards development, product certification, education, and risk-management for public health and safety.
These guys will certify that your production facility is following strict GMPs, all of the necessary quality systems and standard operating procedures (SOPs) are in place and being followed, and all of your documentation is in place and being followed. Having the NSF certification hanging on you wall for all of you visitors to see is a great selling point. It makes the customer feel all ‘warm and fuzzy’ inside. What this shows is that your company is following all of the procedures that are required to make a quality product that is safe for the consumer and, as important, a product that can be consistently manufactured to the customer’s specifications.

Creating an atmosphere of compliance can be challenging but the rewards will far outpace the pains it takes to get there. Better audit scores with your existing customers will lead to more purchase orders and impressing new customer will lead to more business. GMPs are the foundation to creating a growing business.