How to take into account the risks when organizing a big event - the lessons of the air sports festival. Measures to respond and prevent risks Risks in organizing events

Event risk management

This chapter will be full of pessimism and mistrust. But in order to be an optimist and trust everyone, you need to take care of everything in advance and foresee everything.

Any event is a complex process associated with the interaction of a large number of people and equipment, a tangle of interests and obligations. This is a complex system. And, as in any complex system, something might go wrong.

Moreover, something ALWAYS goes wrong (well, almost always).

Someone is late, in a hurry, doing something wrong. At the most important moment, equipment breaks down, powerful forces interfere with the event, the most needed person disappears, etc. Organizing an event can sometimes be like building a pontoon crossing under constant bombardment. Sometimes - to a lunatic asylum under a cheerful March sun. Nothing to do about.

The main thing is that all these problems, problems, problems and complete disasters should not be noticeable to the Client. Moreover, they didn't bother him at all.

Furthermore!

A good organizer must foresee all possible adverse situations and prepare to deal with them in the most professional way.

Your saint is the Apostle Judas Thaddeus. He is the patron saint of hopeless cases, an intercessor in impossible cases and extreme situations. If you know how to pray, pray to him.

The organization of the event is somewhat similar to the beginning of the book "Moby Dick". There the crew of the whaling ship is going to sail. For two years, they will have practically no opportunity to replenish stocks, repair breakdowns, etc. Therefore, they take with them everything they need with a margin, given that things break, tear, wear out, etc. there are spare pairs of socks, frying pans ... Events are organized in much the same way. It is important to foresee everything, to be corrosive, attentive, scrupulous, to plan everything carefully and not to forget anything.

Main risks

The main risk is associated with failure to comply with your own plan . It may turn out that a wonderfully designed scenario, systems of measures to prevent problems, and so on, simply will not be carried out by your subordinates.

In order to prevent this from happening, confirmation from each team member is necessary that he is familiar with the established procedure and rules, as well as with what responsibility he bears for their failure to comply.

There are also risks associated with participants. At events, adults higher education often begin to behave like children. They get lost in three rooms and cannot find a toilet (although they have traveled half the world and know how to navigate in an unfamiliar environment), they intensively lose their own things, accidentally take other people's things, etc., etc. This is not their fault, so this factor should be taken for granted and take into account at work.

Required qualities of an event organizer:

calm. You are ready for anything, all options are calculated, and you know how to behave. And your team knows;
attentiveness. The strength of the little things is that there are many of them. Don't overlook anything.
friendliness. Whatever happens, your guests are your Clients, and they should be treated as friendly as possible;
resourcefulness. Even if you have not prepared an option for the current situation, you must be firmly convinced that you will quickly find an acceptable way out;
competence. Knowledge of your event and all its components, experience, attention should convince Clients, customers that you will solve any problem. And you have to believe it too;
"paranoia". Always be on the lookout.

Special focus - "paranoia". She will save you. Let's start with Murphy's laws: "If trouble can happen, it will definitely happen. If several troubles can happen, they will happen in the most unfavorable sequence."

Accept it - this is normal in our business. In the sense that this is the norm.

Break down your event into its constituent elements. Think and make a plan for yourself what to do if each of these elements falls out. One, two, three, two in a row. The most incredible things can happen. Think about what you will do in different situations.

Find key element(or several) of your event, which can ruin EVERYTHING. There is almost always one. It is for this that you especially prepare, check and double-check everything so that this does not happen.

You must have a backup plan for each possible problems. At least psychologically, you should be ready for anything. Let your rescue plan not compensate for the losses, but the event will not fail completely. Someday this approach - preparing a fallback - will save you. This is professionalism.

Computer risks during the event should be considered separately.

It is known that equipment tends to break down - accordingly, it can break down during the event. The computer may freeze. It may turn out that the program required by the presenter is not working or not installed for you. To avoid this, use duplicate copy. Copy all the data you need (lists, presentations, etc.) to CD, flash memory and have a spare computer with you.

In the office, to reduce the risk of data loss, install a server where all event data will be stored, and regularly copy all necessary and event-related information there. If someone's computer breaks, you'll lose your job in just one day (if you back up data every day).

We have a spare set of the necessary equipment, which we "pointlessly" took to every major event for several years. And at one of the conferences, our computer burned out right during the presentation. It sparked, smoke went out, and everything turned off. What to do? We just replaced the computer. We had a spare. All the necessary presentations were recorded on it, in particular the presentation of the speaker during whose speech the incident occurred. In the hall was our manager, who reported on the walkie-talkie about what had happened to the "problem-solving table". It took several minutes to replace, the speaker missed only a couple of slides. Nothing like this happened for ten years. But when it happened, we were ready. I'm proud of it.

Margin of safety of the event

Always cook Plan b. In some cases, when the probability unusual situation is high, write down a plan B and discuss it with your team, practice it, prepare and write an alternative scenario for plan B.

Consider who can make operational decisions. If you're running an event, you won't be able to be everywhere at the same time - and urgent action may be needed somewhere. Delegate authority (especially if an urgent decision is needed) and responsibility. This is the key to the success and strength of your event.

Many of these decisions will have financial implications for your event and should be understood in advance. If the manager, while on the spot, made a certain decision that entailed expenses, he cannot then be reproached for this, much less fined. If you delegated authority to a person you trust, you must trust that he made the best decision he could make under those conditions, having the information that he had.

It may sound intimidating, but delegation is the only way be flexible in decision-making and act as quickly as possible.

Finally, set a financial limit on responsibility and delegation.

Consider duplicating features throughout the project. Something unexpected can happen to each of us, and a temporary replacement may be required. Let each team member have one or two understudies who are at least in in general terms are aware of the tasks and problems existing in this area of work, and, if necessary, will be able to replace a colleague with minimal losses. Let the understudy not be able to completely replace right person(this is not necessary), but he will be able to support the process of the event, and the whole machine will not stall.

Use your experience: document it and pass it on to other employees so that they can get it right on the first try. It's amazing how often situations and problems recur.

Experience is now the opportunity to do everything right on the first try.

Best compliment I've heard:
"Your events are boring. Somewhat like a Lexus. Everything works like clockwork, nothing breaks and looks great"

Let your events be SO "boring" for the participants.

Ethics

Example of internal risk. Is what you are doing right? If you don't know if you're doing well or not, take the classic Western ethics test.

Before you take any action, imagine that your decision, which you now doubt, will be published tomorrow on the front page in your most important newspaper (Vedomosti, Moskovsky Komsomolets, Ussuriysky Rabochiy) - what for you the most important). If you are ready for this action of yours to be published, do it; if you are not ready, do not do it.

The test does not guarantee that your actions will be considered ethical by others. But at least you yourself will consider yourself a decent person.

Contractor Risks

In Ronin, Robert De Niro plays a very experienced agent. His hero buys weapons from illegal dealers. They meet in a deserted place, the merchant counts the money and offers to pick up the goods near the meeting point - under the bridge. De Niro's character says, "I won't go, let them go here." Why? "If the situation is doubtful, there can be no doubt," he said. Indeed, there was a trap under the bridge. The hero De Niro and his colleagues began to shoot, but the caution of an experienced mercenary saved the situation, they jumped out of the trap, having received both weapons and money. If he had gone, they would have been shot down. But the offer seemed a little doubtful to him ...

The same is with the choice of contractors. If you see that you didn’t like some trifle, some detail and made you doubt, most likely you are right to doubt, and the company has some fundamental problems.

If a courier company sends an offer for cheap rates for the delivery of your correspondence, but cannot send a contract within a day, something is wrong with them.
If the business card of the representative of the printing house is crumpled in the hands - something is wrong with them.
If you can’t get through to the person you need for several days, something is wrong with him.

Once, a certain company approached us with a proposal for cooperation. It was very tempting, but there were grammatical errors in the letter sent by potential partners: when listing the company's Clients, the name of one of the world's brands was misspelled. It seemed strange to us that such a mistake could be made, and we refused to work with them. Yes, on this basis. There were other reasons, but they only confirmed our doubts.

A year later, fate brought us together with this company at one of the partner events. Hm… personal communication confirmed that we were right before...

Accounting for the volume of orders

Carefully check the invoices issued to you by contractors and service organizations. Often, items you don't need are included in the bill: rent of extra, unnecessary premises, extra coffee breaks, extra food, unnecessary staff or equipment. All this inflates the costs of the event and does not add any benefit. You simply will not use paid services. Sometimes this is done simply automatically: the contracting company invoices for a package of services without delving into what you need. Often simple mistakes happen. But you pay for other people's mistakes...

It is not uncommon for such a situation. You agree (with a restaurant, catering, hotel, etc.) on payment for a buffet table according to the actual amount of alcohol consumed. And at the end of the evening you get a bill that exceeds your expectations.

For example, 80 bottles are ordered and there is an agreement that if 50 is drunk, then the bill will be only 50. But at the end of the evening it turns out that 75-80 were drunk.

The correct move is to ask for empty bottles with corks. Otherwise, it may turn out that the opened bottles will simply go home to the attendants. Moreover, it is better to warn the service company in advance that payment will be based on empty bottles with corks.

Knowing that you are serious and that you want to control your spending will help you overcome the temptation to add extra to your bill.

If, as a result of reading this book, you can avoid paying at least two extra bottles of wine, the book has already paid off for you.

Laws of risk management: time and attendance

People may not come to an event, even if they have confirmed a hundred times that they will come.

People can show up to an event without even letting you know they're coming.

People are late for events (including speakers).

Not everyone thinks about the schedule when they start talking into the microphone. But everyone will blame you if it was not respected (everyone, including the speakers from the previous paragraph).

Advice written in blood on the wall of the convention center

Have a list of all key people with mobile phone numbers at the event.

Have with you mobile phone.

Carry a charged mobile phone and charger with you.

You must have money on your mobile phone bill (that is, so that it does not turn off).

It is best if you also have your operator's express payment card with you.

Anti-theft

Unfortunately, there are always plenty of opportunities for petty theft and little scams at events. Note that petty theft is not as harmless as it seems. If you lose something for $100 a month, then by the end of the year the total loss will be $1200, which is not so small. You could buy a computer or fly on vacation.

The first thing you need to do is inventory.

Your team should have a person personally responsible for the safety of inventory (or at least for its timely accounting). He should have a list of all the equipment you bring to the event. How much equipment has left, the same amount should return. After the event, he compares his list with what is available. Thanks to this you have operative information about losses. You can either find or buy the necessary things before the next event.

Approximately the same scheme should work with respect to valuable handout souvenirs. If 100 gifts were prepared at the event, and there were 98 guests, then two gifts must be returned to the company's office (unless otherwise decided).

If possible, number or label the equipment you bring to events—from a projector to scissors. Have a sticker on the projector with your address and phone number. If it disappears by accident (for example, contractors take it along with other equipment), and honest people find it, it will be easier for them to return your property. In any case, it cannot be said that they did not see where this projector should be returned (computer, portable podium, box with important documents, etc.). In the same way, if staplers and scissors are prominently marked with the name of the company or the name of the owner, it will be difficult to recognize them as ownerless.

If the participants see that you treat it as a special resource, then they will not treat your inventory as a "secret gift".

If you distribute, for example, calculators to the participants of the seminar, then they will be very tempted to "forget" to return to the organizers a beautiful and so useful calculator in the household. Someone may not be able to resist this temptation, especially if they are provided with anonymity. No one will check handbags and packages. How to help Clients act honestly? Number the calculators and, when registering, write these numbers next to the names of the participants. Knowing that it's easy to find someone who forgot to return the calculator from the notes helps a lot with accuracy. If the person did not return, he really made a mistake, and you can just very politely remind him of this as a slight misunderstanding. Even if you have to remind ten times.

The main idea: think about how to create conditions, an environment in which theft and simply loss will be reduced.

These measures will not save you from truly dishonest people who are determined to steal something from you. But will help to avoid unnecessary expenses in most cases.

Fraudsters and onlookers

At some events, you will need to prepare for the arrival of scammers or onlookers. For example, many exhibitions are attended by "souvenir hunters" who are also called "vacuum cleaners" - for the fact that they walk around the stand, collecting pens, booklets, bags, etc. Usually these people are easy to identify: they are not very well dressed, their eyes run, there is no intelligible "legend" why they need your booklets and souvenirs. They simply ask them or try to take them without comment. Often, unfortunately, these are pensioners who simply have nothing to do and they have chosen such an occupation for themselves. Prepare your stand attendants on how to respond to such people. Requires courtesy and firmness.

Fraudsters also go to various conferences, banquets and receptions - as opposed to "vacuum cleaners" people with a clear "legend". Usually they pretend to be journalists, employees of large organizations and government agencies - the State Duma, some ministries. They are well dressed and carry themselves confidently.

You can find out who is in front of you only by experience (at our events, some people have already become familiar, and we recognize these people at the expense of "once" and immediately call security) - or by indirect and therefore unreliable signs.

For example, these people may claim that they registered, were accredited to your event, but for some reason did not make it to the list. Or that their organization is solid and does not register for events, but simply sends an employee who "look and evaluate the situation, the relevance of topics" or something like that. In fact, they are interested in the opportunity to eat and drink for free at the buffet table, to get some souvenirs (that is, to rob you of a small amount). Maybe something else, I don't know. Interestingly, despite the fact that they are scammers, they can behave like ideal participants: ask questions, actively participate in discussions, etc.

The behavior of such people is well described in the comedy "Wedding Crashers". Two young people learn about upcoming weddings (they are preparing: they learn about the relatives of the young) and come as guests. At the same time, they are the best guests: they play with children, make wonderful toasts ... In the film, their goal is to seduce young girls who are in a romantic state under the influence of a wedding. After all, a wedding is also an event.

Ask for a business card from a strange visitor. Maybe a passport.

See what e-mail is written on the business card: if it is registered on a free hosting, ask why the company could not provide a corporate e-mail.

Is the postal address and city phone of the company written on the business card? If not, it is hardly a serious company.

Directly from the registration desk, call the indicated phone number, ask what kind of organization it is and whether such a person works there, was he sent to this event?

We are regularly visited by a person who introduces himself as an assistant to a State Duma deputy. Needless to say, he does not work in the State Duma, we called and checked, so now we are taking him out with security.

If a person does not have a business card, you can only say with certainty that there is a stranger in front of you who asks him to believe and give him some of your work (souvenirs, handouts, lunches or snacks and everything that is supposed to be for the participants of your event).

I repeat: everything that has been said is fundamental for events in which participants are provided with something that has material value, for example, during conferences, banquets, receptions. On the public events you most likely won't have this problem.

Insurance and legal issues

In some cases, events are associated with a risk to the property or health of participants. To avoid possible complications, it is worth insuring your event or some part of it.

For example, on corporate party or at winter holiday some of your guests are skating. There is some chance that someone will get hurt. It was skating that could be insured.

In the event of an accident or injury, ensure that an ambulance team is on duty during your event.

Also be aware of copyright issues for music, videos, and photos. Any photo has an owner, and if you decide to use it without permission, he has the right to sue you.

Exceptions are made for non-profit and charitable organizations.

Financial risks and ways to neutralize them

In some cases, you have to pay to participate in the event. Then there is a risk that one of the participants will come and not pay.

If you work in a store and sold a TV on credit, then you don't have to worry too much if the Customer doesn't pay. An employee of the debtor department will contact him, and in the most extreme case, the TV will simply be taken back.

The service, on the other hand, is intangible—you can't get your work back after the event is over—and the risk of default in event management is very significant.

Gathering accounts receivable engaged in both special departments in companies and banks, and specialized companies for which this is the main business. There are many methods of working with debtors, there is literature devoted to this, there are seminars that teach this work (in our company, for example, there are at least five different seminars on this topic). So there is no limit to perfection, and this topic is one of my favorites. But since this book is about something else, I will only very briefly, in the most general terms, talk about the most basic points.

CCL principle. This means: Call-Call-Letter (call-call-letter). That is, you need to repeat very persistently and consistently about what you owe (a person or a company).

If possible, personalize the debtor. You should not refer to the enterprise in the abstract, but to a specific person: let it be the person who was at your event, the company's accountant, the boss.

Write yourself a memo where you reflect the procedure that starts if the Client has not paid on time.

On the day when the payment should be received, write an e-mail letter that the payment has not been received.
On the third day - call and remind personally.
On the fifth day - call, remind, ask for an explanation.
On the tenth day - write a written complaint according to template No. 1: soft, but decisive.
On the twelfth day, call and find out how the claims are progressing.
On the twentieth day - write a written claim according to template No. 2: tougher ..

Think about the motives that are important to your debtor, and try to work on them gradually.

For example, if the problem is not resolved at the participant level, suggest moving the issue to the level of the company's management. In some cases, for a participant (an employee of the company), this may become an unnecessary complication in relations with the management (they are simply afraid of him), and he will do his best not to bring it to this.

Or promise that all other issues of cooperation between companies will be stopped until this issue with a small amount is resolved. To doubt the little is to doubt the great; perhaps this payment will be like a litmus test to show whether it is worth cooperating with a company that has begun to experience financial difficulties.

Letter of guarantee. Sometimes participants refuse to pay, denying that they were at the event. To avoid this, ask all unpaid participants to sign a letter of assurance that payment will be made.

prepare letters of guarantee in advance. Having this document in hand, you will be able to address both the company and personally the participant who put his signature.

Make it a rule for all participants who must pay. Don't let me in without a signature. If a person cannot sign his promises to pay, he knows in advance that he is deceiving you.

Of course, there are exceptions to every rule. Let there be no exceptions to this rule.

Publishing house:	"Mann, Ivanov and Ferber"
The year of publishing:	2006
ISBN:	5-902862-14-0
Volume:	320 p.

YOU WILL LEARN:

Why do you need to manage risk?
what are the five steps needed to manage risk;
how to learn to manage risk.

Risk management is needed when we need to make complex decisions: at the stages of product development, when studying the feasibility of making changes, investigating deviations, organizing the workspace or deciding whether it is possible to combine the production scheme of different drugs, etc., — in fact, where there is a problem of choosing from several options, and where there are no clear, unambiguous requirements. Risk management technology is needed in a situation where there is uncertainty and uncertainty.

Under no circumstances should risk management be opposed to current regulatory requirements. Through risk assessment, it is impossible to justify the non-binding implementation of legislative norms. The risk management process is the source of requirements. History knows many examples when dangerous situations could be avoided if we were better at them. ruled. Pharmaceutical practice also has many developments from which lessons have been learned.

This is how the rules of GMP 1 originated. These rules are only a program to minimize the known risks associated with the production of medicines. Prevention of cross-contamination, confusion or substitution, hygiene rules and allowing personnel to work independently, the choice of a quality control strategy and the maintenance of a quality system are just a few classic examples from the field of risk management.

Many managers believe that they see the full picture of their processes even without additional technologies and intuitively feel the risks to the quality of their products. Indeed, professional, talented managers have amazing intuition. But it is unlikely that it is innate. It can be developed using a risk management methodology. After all, intuition is a subconscious analysis of various options for the development of certain events. including dangerous ones. This is the answer to three key questions: what can happen; if this happens, what will be the consequences and what could cause this to happen? Good intuition is a "spontaneous" risk assessment by a single person. And the conscious application of the risk management process is an objective corporate culture, weakly dependent on subjective factors. Moreover, it is a replicable and easily distributed technology.

Identification of quality risks and their assessment by themselves do not bring results. The result of risk management is the selection and implementation of a strategy for controlling significant risks. The task is not to endlessly play out various scenarios, not to avoid responsibility, but to make correct, balanced, sometimes even risky, but consciously risky decisions.

Risks to product quality are risks to the consumer. The manufacturer of the medicinal product, the holder of the registration certificate and government bodies Regulating the sphere of circulation of medicines, they are responsible to the patient for the effectiveness and safety of products entering the market.

Security is based on modern approaches to risk management. Risk management is the line of defense. It turns out that the only way to ensure the safety of the patient is to introduce effective system quality risk management. This is an element of our responsibility to society. The patient needs guarantees of the effectiveness and safety of the products he takes.

Safety does not mean the absence of danger. A safe state is when we know what, from our point of view, dangerous events can occur and what impact they will have on the quality of our work and products and, as a result, on our consumer. Safety should be ensured not by resorting to prohibitions, but by developing effective procedures. Even if we do not have the opportunity to prevent the occurrence of a dangerous situation, we will at least be able to prepare for it, we will think over measures to prevent and overcome the consequences in advance, we will warn everyone about the presence of a serious danger, for example, by describing it in the instructions.

Hazard is measured by risks, which vary in importance. In order to understand what risks require our special attention need to be properly assessed. If you don't study nature possible risks and hide behind the slogan: "NO risk is not acceptable!" - we will not be able to understand why this or that risk may materialize, and accordingly, we are unlikely to be able to reduce the likelihood of its occurrence. It remains only to say: “Sorry, it happened!” Risks need to be managed systematically and professionally. This is an integral and necessary competence of any manager at any level in any enterprise.

Sometimes you can hear the opinion that risk management is just a catchy name and an incredibly harmful technology that is applicable only to “office” people. It's not like that at all. The personnel of any department can be conditionally divided into two categories: managers and performers.

Performers perform work based on established requirements. Managers establish requirements for the performance of such work, taking into account legislative norms, prescribe algorithms and create conditions, and then control the quality of their performance. In most cases, the contractor does not need a risk assessment. Leaders need it. Needed when they are forced to make important and difficult decisions in the face of uncertainty. For example, there are no legal requirements, or these requirements are stated without specific algorithms for their implementation, or there are several options for implementation, but there is no certainty which option to choose. Managers are responsible for the results of not only their own work, but also the work of the performer. And the higher the uncertainty caused by uncertainty, the greater the responsibility for the consequences of the implementation of the decision. Based on how the manager manages risks, one can draw a conclusion about his professionalism. If the leader skillfully applies this methodology, he comes across as a person of insight, with clear logic and wonderful intuition.

It is these qualities that the technology of risk management develops. In addition, such a leader understands that the mistake of the performer is often caused by the negligence of his leader, which manifests itself in the fact that he did not fully assess all possible threats. And those who believe that all risks are equally dangerous or unacceptable, that is, impossible, are simply not able to make decisions.

As a result, they do it at random, using the favorite “poke” method, or shift the responsibility for the decision to another, for example, to the same performer. It's easier. The practice of doing only what is required and only as understood is inherently flawed. Agree, we often find ourselves in situations where it is difficult, and sometimes scary, to make a decision and there is a feeling of uncertainty and unpredictability regarding how it will affect the quality of the product, and therefore the safety of the patient. And then it may seem that risks are something that does not depend on us. Or vice versa, we will presumptuously believe that we have completely eliminated the risk.

However, in reality this is not the case. Any deviation, failure in the operation of an engineering system or equipment, a claim received or a signal about a side effect of the drug is a realized risk. Of course, you can simply not register deviations and problems that arise, thereby confirming the reliability of your processes. It's a bluff! There are risks and always will be. The main thing is to see the threats in time and calculate the "unforeseen circumstances" under which these threats can be realized, to understand what we can do to prevent this from happening and what to do if it does happen. Do everything that depends on us, and be ready for any development of events.

Is it worth spending a lot of effort where you can get by with little money? If your decision is based on a regulatory requirement and you are sure of it - no, you should not. No risk assessment is needed here. However, if you are in a difficult situation, you need to understand the possible threats and their consequences, calculate in advance how to act in a given development of events, and be prepared for anything.

Risk management improves predictability and certainty, which gives us a sense of confidence. Of course, this is an approach that provides sufficient consumer protection, which, in turn, does not interfere with profits and does not slow down the development of the enterprise.

The main principles of quality risk management in the pharmaceutical industry are set out in the ICH Q9 guidelines, the text of which has been included in the European GMP structure since 2008: first in Appendix 20, and then in Part 3 of GMP. The need for risk management is documented in various guidelines issued by regulatory agencies, professional societies (e.g. ISPE, PDA, IEST) and medical organizations around the world. This methodology is based on the knowledge and experience gained in different countries. However, in Russia there are still disputes about how correct this methodology is. Its erroneous perception has already led to the exclusion of the text ICH Q9 from GOST R 52249-2009 with the “criminal” wording: “ This text is vague and not suitable for practical application ". Why not suitable? The risk management process model presented in the ICH Q9 guidelines (Figure 1) is simple and, most importantly, implementation-oriented (Figure 2).

Figure 1. Traditional quality risk management process (according to ICH Q10 guidelines) of the model presented in ICH Q9

Of course, in risk management, as in any technology, there are enough nuances and details. In order to properly use this technology, it is necessary create internal standards and procedures, to train managers and involved experts, exercise constant supervision for the quality of the evaluation.

Attempts to exclude risk management technology from effective decision making are absurd. It is unacceptable to simply remove the risk management process from the standards just because the author of the national standard does not understand its methodology. One should not go to extremes and accuse risk management technology of being redundant, incorrect, or subjective.

The decision of any person is by its nature subjective. It is necessary to fight not with subjectivity, but with negligence in decision-making. Risk assessment should not be based on guesswork, but on modern scientific achievements, known facts, while taking into account the experimental base, etc. All gaps in knowledge and data should also be attributed to separate category risk, the so-called missing information.

In the same way, risk management methodology cannot be elevated to the status of a “regulatory requirement”. A decision-making technique, by definition, cannot be such. This is the same as forcing everyone to think and act according to a single pattern, which is simply unacceptable and, moreover, dangerous! Risk management is not aimed at circumventing regulatory requirements and not a direct requirement(See Section 1, Part 1 of GMP). The GMP rules declare the need for risk management only to emphasize their paramount importance and their relationship with the quality system and the rules for the proper production and quality control of medicines.

Scheme 2. Quality risk management algorithm. Compiled based on the ICH Q9 model

GMP rules require risk assessment when there is uncertainty. An analysis of the European version of GMP confirms that the need for risk assessment is prescribed only in the following situations:

if during the investigation of the deviation it is impossible to establish the true cause of its occurrence (part 1, clause 1.4 (XIV)). Then it is necessary to select the most probable cause using deductive or inductive risk management methods;
at the stage of making a decision on the possibility of combining the production of different drugs at a single production facility (part 1, clause 5.9);
to create a cross-contamination prevention program (part 1, paragraphs 5.18, 5.19);
when organizing packaging processes (part 1, clause 5.44);
when making decisions on the possibility of processing or re-processing substandard products (part 1, clauses 5.62, 5.63);
when deciding on the possibility of resuming the turnover of all or part of the returned products (part 1, clause 5.65);
when substantiating the scope of validation work (Appendix 15).

In other words, when there is a need to make difficult decisions. And, mind you, decisions that do not conflict with regulatory requirements.

From the effectiveness of decisions taken by the manager management decisions depends on the successful functioning and survival of the enterprise. Consideration should also be given to the fact that, in addition to obvious benefits the risk management process has serious shortcomings (Table 1).

Table 1

Advantages and disadvantages of the quality risk management process

In its essence, the statement of the problem is also wrong - to exclude only the risks that are indicated in the regulatory documents. I repeat: regulations- this is a certain average perception of known risks. Each production has its own specifics, and regulatory requirements do not take it into account.

Also, do not strive for total control. It is important for us to be able to identify the most dangerous risks and develop adequate and timely measures to manage them. Even not the largest assessment can identify dozens, even hundreds of various risks. This can confuse any specialist, since it is not clear what to do with them and what to take on in the first place. Of course, it would be nice to eliminate all risks, but most often this is not possible. Our resources, like cash, are always limited, so we are forced to choose priorities.

It is intuitively clear that some risks require top-priority decisions, while certain ones are of no interest to us at all. To determine priority actions, it is necessary to establish the elements of risk - the level of its impact and the likelihood of implementation. If a hazard materializes, it can have different impacts that largely determine the severity of the risk, just as assessing the likelihood of a negative event occurring can tell us a lot and predetermine our perception of safety.

By definition, risk- is a combination of the probability of realization of a particular danger and the severity of the harm caused by it. There is no methodological error here. Indeed, quantities different in meaning are multiplied and a conclusion is drawn based on the result. When using two risk assessment criteria, we are not talking about averaging it.

Probability is taken into account in order to cut off incredible, unrealistic events. Another issue is that we still prioritize based on the level of their impact.

The methodological error lies in the fact that some domestic critics do not take into account the main axiom of risk management: the severity of harm takes precedence over probability.

Therefore, if, for example, we consider the example of an airplane that has set its teeth on edge, an incorrect gradation of risk when using quantification. Consider two events using a five-point scale (from 1 to 5).

First. A non-dangerous event is a late arrival of the aircraft (harm severity equal to 1), but often repeated (probability equal to 5).

Second. A dangerous event is a plane crash (harm severity is 5), but extremely rare (probability is 1).

Indeed, multiplying the weight coefficients gives the same figure 5, but does not equalize their significance.

The first event is a minor risk, but the second event can be ranked as a significant risk (due to the fact that the severity of harm exceeds a certain threshold, for example 2), and therefore will require our close attention and development of a program to control such a risk, ensuring continuous monitoring its effectiveness. The risk control program can vary from a single action to a separate comprehensive plan.

Embedding the risk management process in everyday life the enterprise does not require investments and does not imply the introduction of any complex systems and models. It only takes five steps.

First step is to learn to see and clearly identify dangers (threats). We often do this empirically, dare I say unconsciously. This is not enough. To fully identify risks means to take into account all their parameters.

Second step- you need to learn how to create risk profiles, i.e. systematically determine all the risks inherent in the object of our assessment (draw up a risk assessment protocol). This is important because risk management is useful, but not sufficient.

A task third step is to learn how to determine which risks to deal with first. To do this, you need to be able to analyze risks, prioritize.

For successful implementation fourth step it is necessary to select and implement strategies for managing significant risks. Here it is important to understand what specific actions we need to take in order to gain more and / or lose less.

And finally fifth step- learn how to create an optimal "safety cushion", i.e. develop an action plan in case a particular risk is realized. The task of this step is to prepare for any development of events and always have a plan "B". These are basic steps applicable in any situation, in any business and at any level of the enterprise hierarchy. The model given in ICH Q9 is used in most countries of the world. A similar model is presented in the basic ISO standard 31000 2 . Today, in order to put the risk management process into practice pharmaceutical companies there is a serious methodological base, which has been actively developed since the 60s of the last century. More than 100 risk assessment methods are known. In the ICH Q9 guidelines, only six of the most common tools are declared (Table 2), 31 methods are described in ISO 31000, and there are even more of them in life. However, this does not mean that each should be used. You need to choose for yourself those risk assessment tools that you can work with and that you will trust. The main thing is that they are understandable to you.

table 2

Summary of risk assessment methods stated in ICH Q9

Risk Assessment Tool	Specialization	Assessment detail	Complexity	Flaws
PHA - preliminary risk analysis				You need to be able to predict threats. Does not allow establishing relationships between different threats
HAZOP - Risk and Opportunity Analysis				Requires a lot of information about the object of evaluation. Assesses threats by components/elements without regard to other components/elements
HACCP - Hazard Analysis and Critical Control Points		Various		Not suitable for assessing the relationship between failures and their causes. Does not allow assessing risks associated with objects/systems
FMEA - Failure Modes and Effects Analysis				Not suitable for retrospective risk assessment. Does not establish relationships between failures/threats and their causes
FTA - fault tree analysis				Can be monotonous and lengthy
RRF - classification and screening of risks				Not suitable for retrospective risk assessment. Unsuitable for a small number of identified threats

Thus, to learn how to manage risks professionally, you need to practice and gain some experience. Naturally, this takes time and effort. First to a greater extent, then to a lesser extent. The main thing is to start gradually introducing risk management technology into your work. To do this, you do not need to allocate some special day, wait for some event or mood. By managing risks, we ensure the quality of our work, and vice versa - by ensuring quality, we manage risks. The result of risk management is a guarantee of the quality of your products, compliance with regulatory requirements, obtaining stable profits, and therefore a guarantee of our stability. Modern life it insistently demands!

Per. from English. Groups of companies VIALEK

1 GMP (Good Manufacturing Practice) - proper Internship(standard for production management system). - Note. ed.

Organization of events is a complex and sometimes unpredictable business. At almost all events, there are situations when something does not go according to plan and gets out of control. There are many risks associated with organizing events, and it is about them that we will talk in this article.

Staff

People are always a source of risk. Even if you work with professionals, you should not exclude the human factor. The host may fall ill, the speakers at the event may not arrive, the waiters may not be able to cope with the work. You should always have the phone numbers of people who can quickly come and save the situation. Numbers for hosts, emergency services and food delivery will never be redundant, and in some cases will help save the entire event from failure.

Technology can break

Be aware that your camera or camera may run out of battery, your computer or projector may stop working, or the power may go out. Such situations should always be foreseen in advance. Carefully monitor the work of your contractors, check all equipment in advance, always have a few cables and extension cords in stock. You never know when you might need them, but in case of force majeure, they will help you a lot.

Before the event itself, check with the owners of the site if there is a spare generator on it. If not, then you need to find out if there are people who can quickly fix problems.

Speakers at conferences

Check guest speakers in advance for public speaking experience, otherwise you may end up in a situation where the performance becomes a failure due to the lack of experience of the speaker. In this case, you will be saved by rehearsals before the event, which will help prepare an inexperienced speaker for the stage and save you from unforeseen situations.

Abrupt weather change

There is always the possibility that at the most unexpected moment it will rain or a thunderstorm will begin. And you must be ready for this. Think in advance what you will do in this case, where the guests of the event will have to go. If the start of the event depends on the weather, then you need to think about how long the start can be postponed, what can be done at this time for people who have gathered for the start of the holiday.

Guests may not behave as planned

The event plan of the event manager clearly spells out everything that should happen at the event: when the next speaker comes out at the conference or when the time comes for a “surprise” for the guests of the holiday. Sometimes guests may not pay attention to a request to go somewhere, because they are too passionate about the conversation, accidentally spoil the key decoration, and so on. Therefore, you need to remember that this plan is only in front of you and the guests do not think about timing and how complex the event they came to is arranged.

Material prepared:

Great events. Technologies and practice of event management. Shumovich Alexander Vyacheslavovich

Main risks

The main risk is associated with failure of your own plan. It may turn out that a wonderfully designed scenario, systems of measures to prevent problems, and so on, simply will not be carried out by your subordinates.

There are also risks associated with participants. At events, adults with higher education often begin to behave like children. They get lost in three rooms and cannot find a toilet (although they have traveled half the world and know how to navigate in an unfamiliar environment), they intensively lose their own things, accidentally take other people's things ... This is not their fault, so this factor must be taken for granted and taken into account in the work.

Required qualities of an event organizer:

– calm. You are ready for anything, all options are calculated, and you know how to behave. And your team knows;

– attentiveness. The strength of the little things is that there are many of them. Don't overlook anything.

– friendliness. Whatever happens, your guests are your Clients, and they should be treated as friendly as possible;

– resourcefulness. Even if you have not prepared an option for the current situation, you must be firmly convinced that you will quickly find an acceptable way out;

– competence. Knowledge of your event and all its components, experience, attention should convince Clients, customers that you will solve any problem. And you have to believe it too;

– "paranoia". Always be on the lookout.

A special focus is "paranoia". She will save you. Let's start with Murphy's laws: “If trouble can happen, it will definitely happen. If several troubles can happen, they will happen in the most unfavorable sequence.

Accept it - IT'S NORMAL in our business. In the sense that this is the norm.

Find key element(or several) of your event, which can ruin EVERYTHING. There is almost always one. It is for this that you especially prepare, check and double-check everything so that this does not happen.

You should have a back-up plan for every possible problem. Least psychologically you have to be ready for anything. Let your rescue plan not compensate for the losses, but the event will not fail completely. Someday this approach - preparing a fallback - will save you. This is professionalism.

Computer risks during the event should be considered separately.

We have a spare set of the necessary equipment, which we “pointlessly” took to every major event for several years. And at one of the conferences, our computer burned out right during the presentation. It sparked, smoke went out, and everything turned off. What to do?

We just replaced the computer. We had a spare. All the necessary presentations were recorded on it, in particular the presentation of the speaker during whose speech the incident occurred. Our manager was in the hall, who reported on the walkie-talkie about what had happened to the “problem-solving table”. It took several minutes to replace, the speaker missed only a couple of slides.

Nothing like this happened for ten years. But when it happened, we were ready. I'm proud of it.

From the book Logistics: lecture notes author Mishina Larisa Alexandrovna

LECTURE No. 10. Risks in logistics 1. Essence and content, types of risks In any practical implementation logistics system, from the process of movement of goods to the processes of movement of orders in the market space, covers a large number of heterogeneous aspects, work

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Technical Risks Technical risks are problematic and can often lead to project closure. What happens if a system or process fails? Contingency or back-up plans are made when there are

Once you have a list of tasks, arrange them logically in reverse order, from the day of the upcoming event to the present.

Write down key dates. These are kind of checkpoints - checkpoints that check how well the plan is being implemented. On these key dates, the main events in preparation for the event should occur.

Check how the dates fit with the calendar, take into account holidays, weekends, etc. See how the dates fit in with the work plans of the company as a whole.

Show your plan to colleagues, contractors (all or that part that concerns them) and make the adjustments indicated by them.

The plan is ready, start implementing it.

Bringing the components of the plan together. It is also important that the components are interconnected. One part of the team must not overtake another. In some cases you are involved in the preparation of only one event, in others you are responsible for several events at different stages of preparation. If a person does not know that other actions depend on his actions, then he may not realize the importance of the work, the measure of his responsibility and miss something somewhere or, conversely, run ahead.

For example, you talk to a designer and tell him on Tuesday the 1st that you need to make a layout for the booklet, say on Thursday the 3rd. The designer says: “OK.” All the source materials are available for the booklet, and there seems to be enough time to complete the task. But the designer is interested in some other business and does not have time to finish the layout a little, deciding that he will finish it on Friday morning, 4- At this time ... You agree with the printing house that on Friday morning, the 4th, you will have a layout and you

ready to send it to print. Typography is preparing, planning loading time printing machine, time in the repro center for color separations, etc. If you miss the time, it will be given to another customer and you will have to queue up again.

The printing house promises that it will print the booklets in four working days, that is, on the evening of Friday, the 11th, you will have a booklet. This is normal, because on Monday the 14th you have an exhibition, where you bought a stand and paid $5,000 for it, arranged to meet with several very important customers, hired promotional staff to distribute booklets ... All this money is wasted if the designer did not complete the work on time. But he doesn't

knows how important this day is… Realizing that he needs to make this layout and the work of ten people depends on its speed and the budget is tens of times higher than the cost of his work, the performer treats his work more responsibly, he understands the motivation and understands why he is required submit it today, not another day.

Some parts of the event (for example, the opening and closing ceremonies) will have to be thought out and prescribed second by second, indicating which actions are taking place at the same time, which are a signal for other actions, etc.

Also, when drawing up such a plan, you need to pay attention to ensuring that your plan is understandable to other people. Check how well you explain everything. For example, after talking about your plan, ask the team to write a script. And then compare it with your own version.

Problems

Event risk management

Any event is a complex process associated with the interaction of a large number of people and equipment, a tangle of interests and obligations. This is a complex system. And like any complex system, things can go wrong. Furthermore. Something ALWAYS goes wrong (well, almost always).

The main thing is that all these problems, problems, problems and complete disasters should not be visible to the participants. And even more so did not bother them. Moreover!

A good organizer must foresee all possible adverse situations and prepare to deal with them in the most professional way.

The organization of the event is somewhat similar to the beginning of the book "Moby Dick". There the crew of the whaling ship is going to sail. For two years, they will have practically no opportunity to replenish stocks, repair damage, etc. Therefore, they take with them everything they need, with a margin, given that things break, tear, wear out. They have extra pairs of socks, frying pans, and more... Events are organized in much the same way. It is important to foresee everything, to be corrosive,

attentive, scrupulous, carefully plan everything and do not forget anything.

Main risks

The main risk is associated with failure of your own plan. It may turn out that a wonderfully designed scenario, systems of measures to prevent problems, and so on, simply will not be carried out by your subordinates.

There are also risks associated with participants. At events, adults with higher education often begin to behave like children. They get lost in three rooms and cannot find a toilet (although they have traveled half the world and know how to navigate in an unfamiliar environment), they intensively lose their own things, accidentally take other people's things ... This is not their fault, so this factor must be taken for granted and taken into account in the work.

Required qualities of an event organizer:

With serenity. You are ready for anything, all options are calculated, and you know how to behave. And your team knows; Attentiveness. The strength of the little things is that there are many of them. Don't overlook anything.

Friendliness. Whatever happens, the participants are your guests and should be treated as friendly as possible; resourcefulness. Even if you have not prepared an option for the current situation, you must

be firmly convinced that you will quickly find an acceptable way out; Competence. Knowledge of your event and all its components, experience, attention

must convince everyone that you will solve any problem. And you have to believe it too;

"Paranoia". Always be on the lookout.

A special focus is "paranoia". She will save you. Let's start with Murphy's laws: “If trouble can happen, it will definitely happen. If several troubles can happen, they will happen in the most unfavorable sequence.

Accept it - IT'S NORMAL in our business. In the sense that this is the norm.

You should have a back-up plan for every possible problem. At a minimum, psychologically, you should be ready for anything. May your rescue plan

does not compensate for the losses, but the event will not fail completely. Someday this approach

- preparing a fallback - will save you. This is professionalism.Computer risks during the event should be considered separately.

Event errors

Most stupid mistakes are made by the organizers at the very beginning of the event and at the very end.

As for the beginning, most often the flaws are due to the fact that there was not enough time for preparation (literally some minutes), and therefore various overlays arise. The recipe for getting rid of them is only in proper planning and timely preparation. After the event started and all those present were drawn into its rhythm, mistakes

becomes smaller; the organizers get the feeling that everything is going well and the most difficult is over. And this is also a very dangerous moment. People relax, which means that mistakes are possible again.

If you are in charge of the event, make sure that everything goes especially well at the end, so that the employees are especially collected and attentive. A brilliant end to the event will help to leave a brilliant impression.

Margin of safety of the event

Always prepare a plan B. In some cases, when the likelihood of an unusual situation is high, write down a plan B and discuss it with your team, practice it, prepare and write an alternative scenario for plan B.

Consider who can make operational decisions. If you're running an event, you can't be everywhere at the same time - and urgent action may be needed somewhere. Delegate authority (especially if an urgent decision is needed) and responsibility. This is the key to the success and strength of your event.

Many of these decisions will have financial implications, and this should be understood. If the manager, while on the spot, made a certain decision that entailed expenses, he cannot then be reproached for this, much less fined. If you delegated authority to a person you trust, you must trust that he made the best decision he could make under those conditions, having the information that he had.

It probably sounds harsh, but delegation is the only way to be more flexible in decision-making and act as quickly as possible.

Consider duplicating features throughout the project. Something unexpected can happen to each of us, and a temporary replacement may be required. Let each team member have one or two understudies who are at least in general aware of the tasks and problems that exist in this area of work, and, if necessary, will be able to replace a colleague with minimal losses. Let the understudy not be able to completely replace the right person (this is not necessary), but he will be able to support the process of the event, and the whole machine will not stall. Use your experience: document it and pass it on to other employees so that they can get it right on the first try. It's amazing how often situations and problems recur.

Experience is the opportunity now to do everything right on the first try.

Best compliment I've heard:

“Your events are boring. Something like a Lexus. Everything works like clockwork, nothing breaks and looks great.”

Let your events be SO "boring" for the participants.

Ethics

Example of internal risk. Is what you are doing right? If you don't know if you're doing well or not, take the classic Western ethics test. Before you take any action, imagine that your decision, which you now doubt, will be published tomorrow on the front page in the most important for you

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