Product Recall Due To a Quality Issue
Product Recall Due To a Quality Issue
The product recall I will be discussing is that of Motrin Infants drops which occurred in early September of this year. These infant drops are manufactured and distributed by Johnson & Johnson in the US through their subsidiary McNeil Consumer healthcare. Motrin is a baby drop formula used to treat fever, aches and pains in children 2 years or younger (webMD.com 2013). The recall occurred when plastic particles the size of a poppy seed were found in a batch which had not yet been released into the market. On investigation Johnson & Johnson identified that the ibuprofen used in the drops which is sourced from an outside vendor was the source for the plastic particulates. Johnson & Johnson then identified that 3 batches which had been released into the market had contained the affected batch of ibuprofen received from the vendor and recalled all bottles manufactured with this ibuprofen.
This was estimated to be total of 200,000 bottles of Motrin baby drops (Beasley, 2013). This recall was a voluntary recall as a precaution as there were no known effects of the plastics being in the drops. However this recall has done even more damage to the Johnson & Johnson reputation as there had been recalls previous to this with other ibuprofen related products. Although this issue was traced back to an external vendor it does bring into question how well Johnson & Johnsons quality systems are being adhered to. . As part of Johnson & Johnson’s ‘dedication to quality’ policy statement which is drafted in line with ISO9001:2008, it refers to its ‘global quality’ policy in which it includes the following line as one of its aims: “Ensure that all products we purchase from suppliers meet our requirements.” (www.jnj.com 2013).
The company also state in their ‘ingredient safety’ statement: “Our companies employ pharmacists, toxicologists, laboratory analysts and other health scientists to conduct thorough evaluations before raw materials are used.” (www.jnj.com 2013). As is the case for the first statement this was not followed as the root cause issue was determined to be a raw material received from an external vendor which had slipped through these tests. This then brings into question the effective of quality checks currently in use.
This recall, in my opinion was avoidable if the quality measures listed in both the statements referred to earlier had proper systems and checks in place to ensure first time quality. In this case this was most likely not achieved as the quality testing and checks in place were not sufficient enough to detect the issue which led to the recall. A review of the testing protocol for materials received would be required to ensure an improved quality of product and also a more stringent system of testing finished product before it leaves the manufacturing floor. This may be through more frequent testing of the product during manufacture i.e. if testing happening once per 100 bottles manufactured this number may need to be reduced.
Another method of ensuring this would not happen would be for Johnson & Johnson to review their supplier’s quality checks and ensure that they are of a high standard as stated in Johnson & Johnson’s quality statement for ingredients. This may occur by Johnson & Johnson carrying out a plant visit to the supplier and carrying out an audit on the quality system in place for this supplier.
Johnson & Johnson’s corrective action for this issue was as a review of the issue with the supplier to ensure a more effective method of detecting this issue was implemented. This was the only action taken by Johnson & Johnson in ensuring this would not occur again. While this is one of the appropriate solutions, I feel that Johnson & Johnson should look within their systems for flaws and implement a more stringent quality system for this and other products. The reason that I think this required is due to the number of failings Johnson & Johnson have had in the past such as in 2010. In this year they had an issue with over 40 non-prescription products such as children’s Tylenol were recalled due to issues in its Fort Washington, Pennsylvania manufacturing plant
This also led to a law suit in which it was claimed that Johnson & Johnson had concealed failures in its quality control (Beasley, 2013). This is further compounded by the recall of a second product within a week of the recall for Motrin. This was a recall of Risperdal Consta an antipsychotic treatment which in routine testing showed evidence of mould (Thomas, 2013). Johnson & Johnson have indicated that both recalls were voluntary and precautionary as that both issues which led to the recalls were not believed to be of harm to patients.
In researching for this recall it was staggering to see exactly how many different recalls Johnson and Johnson have had in recent times and how after each incident that it appears no lessons in relation to how they have failed their quality system have been learned. While as a company there are many different subsidiaries and branches of the business it is an overall responsibility of Johnson & Johnson to ensure quality is a fundamental part of each part of the business and spearhead its importance in preventing recalls such as this and many others. I have also learned that Johnson & Johnson have recently put in place a new chief executive in Alex Gorsky who has a focus on trying to repair the quality policies and systems within the company (Thomas, 2013). Looking at Johnson & Johnson as one of the largest companies in the world it’s difficult to understand how they let slip of their quality system as this is the cornerstone of success in any business.
In conclusion not only is a quality system essential to have in a company it is also important that the system is the correct one for the company to ensure first time quality. Finally the most important aspect of a quality management system is that every employee has the same level of knowledge of the system from the top management down to the employees on the production floor as the system should be a responsibility of everyone within the company to ensure first time quality and prevent recalls such as this.
Beasley, D. 2013. J&J unit issues U.S. recall of Motrin drops for infants. [online] Available at: http://www.reuters.com/article/2013/09/06/us-jj-recall-idUSBRE98512M20130906 [Accessed: 25 Sep 2013].
Thomas, K. 2013. Log In – The New York Times. [online] Available at: http://www.nytimes.com/2013/09/13/business/new-recalls-by-johnson-johnson-raise-concern-about-quality-control-improvements.html?_r=0 [Accessed: 3 Oct 2013].
www.jnj.com. 2013. Ingredient safety. [online] Available at: http://www.jnj.com/sites/default/files/pdf/ingredient-safety.pdf [Accessed: 30 Sep 2013].
Webmd.com. 2013. Motrin Infants Formula Recalled – WebMD. [online] Available at: http://www.webmd.com/parenting/baby/news/20130909/motrin-infants-formula-recall [Accessed: 20 Sep 2013].