Preventive action: Identifying opportunities
It would not be new to say that in the ISO9001: 2015 version all the clauses dealing with preventive action were removed (and a pity ..), and in contrast risk-based thinking was added – but despite the removal – these two issues are important and closely related …
The problem is that since the birth of ISO 9000 companies have not been able to understand the meaning of “preventive action” and on the other hand, if you approach a group of businessmen and ask them about risks, each will enjoy understanding … therefore, if the regulation “removed” the issue The preventative action in the common standard, why are we still encouraged to consider implementing it as in the past?
The preventive action of J&J
The following story is not a fairy tale, but a tragic and famous affair … Imagine you finished a busy day with a headache, or a child has a fever. By jumping to the pharmacy you buy an over-the-counter medicine and believe that the condition will improve quite quickly, but instead – it worsens and becomes a serious illness. Your life changes forever.
In the early 1980s near Chicago, Illinois, USA, several people in different neighborhoods became ill and died from the onset of similar symptoms.
Being a quality staff member or senior manager in the production department of a company involved in causing death is a very difficult experience … For J&J, which until then had enjoyed an international reputation for safety, quality and efficiency, everything changed in an instant. The “Tylenol murders” led to a police investigation as well as an internal investigation.
The overall cost impact of the incident was never disclosed, but the initial economic cost to Johnson & Johnson was reportedly $ 100 million for the product recall (destruction) and destruction of some 31 million packages of the drug found in homes and stores.
Johnson & Johnson was cleared of suspicion of intentional harm in the first place and inspections found the production facilities clean. The final conclusion was that the bottles were purchased by someone who injected cyanide into them and then returned to store shelves.
Opportunities for forethought
While Johnson & Johnson’s initial focus was on repair and remedial action, in the end it was the preventative action that has affected many of the consumer, food and health products around the world since …
The first thing Johnson & Johnson did was take the product off all store shelves, and then return the product to the market in packaging with a special triple closure.
The crisis has led to the development of packaging that does not allow tampering with or damage to the product. This packaging has become, in fact, the standard accepted today in many of the food and medicine products. While the action was driven by remedial action of paramount urgency, the pan-industrial standard born as a result is a prime example of preventative action.
Another industry change that has been made as a preventative measure is the introduction of “caplets”. The capsules are capsule-shaped pills that make it easier to swallow but make it difficult to deal with the product and damage it. While the capsules – Capsules – could be opened, added to a substance or changed the substance in the contents, and then closed without it being noticeable on them.
Following the invention of the chapel, it is very difficult today to change products and return them to the distribution system so that customers will purchase them at random.
Effective remedial action will always include effective preventative action, as the proverb says – a wise man is one who knows how to get out of trouble that a wise man would not have gotten into.
Identify opportunities for preventative action and examples
In a previous post we examined the CAPA requirement in ISO 13485 and highlighted the issue of preventive action. The requirements of the preventive action are similar to those of the corrective action. The distinction between the two types of actions is related to timing. Corrective action is taken in response to an error or problem. Preventive action is taken as soon as the potential for the problem is identified.
For example: Data analysis may indicate a possible evolving trend of declining FPY (first-pass output). Validation of the test method will provide a high level of confidence in determining what is a proper pass / fail, which means we can expect defective products not to be released to the market. Still, opening an investigation before poor quality products sneak in and out of the market – and keeping thorough records – would be a deterrent. This category of preventive action is also important for the corrective action. If the problem has already occurred, the challenge will be to prevent its recurrence in the future.
Sources of opportunities for preventative action can be identified through routine production reviews, management surveys and internal audits. The events in which data are reviewed by trends or collections of samples designed to represent a longer timeline. Risk assessments are very appropriate for identifying opportunities for preventative action. Identifying risks and prioritizing will lead to a ranking of the problems and of course the highest priority or opportunity for injury or product failure is the one that will be addressed in the process and product planning stages. Items whose risk level is lower, however, may be candidates for further examination under a preventive action plan.
Another source of preventative action are competing products and public records. Even if your products are successful in the market, the challenges of the competitors may indicate a possible weakness in you as well …
Did you know that the FDA may initiate tests or audits not because of a report that deals specifically with your organization but because of issues that arise around similar products manufactured by other companies? In addition to the stories featured in the news, you can review public records on product returns, adverse events and reports on reviews and reviews. Although it is not customary to publish reviews of the ISO 13485 standard to the general public, FDA reviews are actually reported.
Review information sources that address issues that have arisen around products similar to yours. This will give you important insights as well as the opportunity to solve problems even before they arise. In the best case scenario all this will help you to avoid unwanted tests and failures in advance.
It is typical that both records of corrective actions and of preventive actions will be reviewed by examiners and examiners. Some may comment on the relationship between remedial and preventative actions as a sign of the effectiveness of the island control system.