Category: כתיבת נהלים

5 Whys
So why 5? 😉 Actually there is no special magic in number five .. but the general idea is to dig deeper below the surface.
As we dig deeper into the problem using the “why” question over and over again, we are allowed to get to the root of the problem. Sometimes we have to ask less than five “why” and sometimes more – here is how the actual method works:

(1) Why did the customers not eat the dish? Because she had no taste for them.
(2) Why was it not tasty? Because the taste felt weird.
(3) Why did the dish taste strange? Because the refrigerator did not cool it properly.
(4) Why did the refrigerator not maintain the required cold? Because it was not connected to electricity.
(5) Why was the refrigerator not connected to electricity? For the apostle stumbled on his electric wire.
(6) Why did the apostle stumble on the power cord? Because the wire is on the floor and crosses the aisle.
(7) Why is the wire in the aisle? Because there is no active plug on the side of the room where the refrigerator stands.

The elegance of this method lies in its simplicity. All you have to do is ask “why?” For any previous answer. The weakness of the method lies in the fact that the conclusion depends on the previous answer. It is important to be careful and make sure that the answers do not produce a confirmatory bias.

Ichikawa

Method: Refers to the processes used.
Material: Can refer to raw material, components and supporting materials.
Manpower: Can include training and skill set as well as number of resources.
Machines: can include those directly related to the process as well as the supporting equipment.
Measurements – Measurements: include the data as well as the equipment, test methods, calibration and quality controls designed to produce measurements.
Milieu – Environment: Can include the humidity levels, temperature, noise, vibration and other characteristics of the space where the problem appeared.

The team will brainstorm all the information and data, consider all the facts related to the situation, and then point out the factors directly involved in the problem.

Chronology – an overview of events and factors
In this approach, the team researching the roots of the problem will trace the process that led to the problem, not with the help of the question “why?” But with the question “What happened next?” The team will go through the process at least twice. First with a smooth page, and then with a copy of the procedure.

Go through the process that led to the problem. Do not judge the answers, just write them. Ask verifying questions like “Did you do anything before this step”? It is important to get accurate answers and remember that employees often tend to say what they were supposed to do. Be patient and do not react when you hear that a procedure was not performed accurately.
After verifying the interview, decide if there were any sub-processes that require a similar in-depth investigation. After completing all the interviews move on to the next step.

Next you will go through with the interviewed employee about the procedure as it is written and worded. At each step they asked, for example: “The procedure says you have to mix twenty minutes before adding the next ingredient. You added all the ingredients before you mixed. I’m right”? Notice all the places where the employee acted in accordance with the procedure and all the points where there were anomalies. Be kind and pleasant to the employee who provides you with information. A relationship that has a high level of trust will yield effective results time and time again.

After completing the interviews review the steps or steps that included anomalies to determine if any of them might have created the problem that was discovered. Follow-up interviews will help determine if additional guidance or training is needed or perhaps additional process controls, whether the procedure is deficient, or whether there is additional corrective action to suit the situation.

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.