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

Risk management of events

This chapter will be filled with pessimism and disbelief. 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 technology, a ball of interests and obligations. This is a complex system. And, as with any complex system, things can go wrong.

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

Someone is late, in a hurry, does something wrong. At the most important moment, equipment breaks down, powerful forces interfere, interfering with the event, the most needed person disappears, etc. The organization of an event can sometimes be similar to the construction of a pontoon crossing under constant bombardment. Sometimes - to a lunatic asylum under the cheerful March sun. It's nothing you can do.

The main thing is that all these problems, problems, problems and complete disasters are not noticeable to the Client. And even less did they bother him.

Furthermore!

A good organizer is obliged to anticipate all possible adverse situations and prepare for their solution in the most professional way.

Your saint is the apostle Judas Thaddeus. He is the patron saint of hopeless deeds, an intercessor in impossible deeds 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 practically not have the opportunity to replenish stocks, fix 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, 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 of your own plan... It may turn out that a well-designed scenario, systems of measures to prevent problems, and so on, simply will not be implemented by your subordinates.

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

There are risks associated with participants... At events, adults with a college degree often start acting 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 unfamiliar surroundings), they intensively lose their own things, accidentally take strangers, etc., etc. This is not their fault, so this factor must be taken for granted and take into account in work.

Required qualities of an event organizer:

calmness. You are ready for anything, all options are calculated, and you know how to behave. And your team knows;
attentiveness. The power of little things is that there are many of them. Don't overlook anything.
friendliness. Whatever happens, your guests are your Clients, and you need to treat them 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 solution;
competence. Knowledge of your event and all its constituent parts, experience, attention should convince Clients, customers that you will solve any problem. And you must believe it too;
"paranoia". Be always on the alert.

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

Accept this - 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, second, third, two in a row. The most incredible thing can happen. Think about what you will do in different situations.

Find the key element (or several) of your event that can ruin EVERYTHING. Almost always there is one. Prepare for this especially, check and double-check everything so that this does not happen.

You need to have a backup plan for each potential problem. At least psychologically, you must be prepared for anything. Your rescue plan may not compensate for the losses, but the event will not completely fail. Someday this approach - preparing a fallback - will save you. This is professionalism.

Computer risks when holding an event, it is worth considering separately.

It is known that technology is prone to breakdown - accordingly, it can break during an event. The computer may freeze. It may turn out that your program is not working or the program required by the presenter has not been installed. To avoid this, use duplicate copying. 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 down, you will lose your job in just one day (if you copy data every day).

We have a spare set of the necessary equipment, which we “senselessly” carried to every major event for several years. And at one of the conferences our computer burned out right during the presentation. He sparkled, went smoke, 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 and reported the incident to the "problem solving table" by walkie-talkie. It took a few minutes to change, the presenter only missed a couple of slides. For ten years nothing like this has happened. But when it happened, we were ready. I'm proud of it.

Safety margin of the event

Always cook plan b... In some cases, when the likelihood of an unusual situation is high, write out plan B and discuss it with your team, practice its implementation, 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 required somewhere. Delegate authority (especially when 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 this should be understood in advance. If the manager, being on the spot, made a decision that entailed expenses, he cannot then be reprimanded for this, and even less fined. If you delegated authority to a person you trust, you must believe that he made the best decision that he could make in those conditions, having the information that he had.

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

Finally, set a financial limit for responsibility and delegation.

Consider duplicating functions throughout the project. Something unexpected may happen to each of us, and a temporary replacement may be required. Let each team member have one or two understudies who, at least in general terms, are aware of the tasks and problems existing in this area of \u200b\u200bwork, and, if necessary, can replace a colleague with minimal losses. Let the understudy not be able to completely replace the necessary person (this is not necessary), but he will be able to support the event process, and the whole machine will not stall.

Leverage your expertise: Document it and share it with other employees so they can get it right on the first try. It's amazing how often situations and problems recur.

Experience is an opportunity now from the first attempt to do everything right.

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

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

Ethics

An example of internal risk. Is what you are doing right? If you don't know whether you are doing well or not, apply the classic ethics test used in the West.

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

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

Contractor Risks

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

The same is with the choice of contractors. If you see that some trifle, some detail you did not like and made you doubt, most likely you are rightly doubting, and the company has some fundamental problems.

If the courier company sends an offer on cheap rates for the delivery of your correspondence, but cannot send an agreement during the day, something is wrong with them.
If the business card of a typography representative wrinkles in their 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 company approached us with an offer of cooperation. It was very tempting, but in the letter sent by potential partners, grammatical errors were made: when listing the company's Clients, the name of one of the world's brands was spelled incorrectly. It seemed strange to us that one could make such a mistake, and we refused to work with them. Yes, on that 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 partnership events. Hmm ... 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 providers. Often items that you do not need are included in the bill: renting unnecessary rooms that you do not need, unnecessary coffee breaks, excess food, unnecessary service personnel or equipment. All of this inflates the costs of the event and adds no value. You simply will not use paid services. Sometimes this is done just automatically: the contractor will invoice for the package of services without going deep into what you need. Often there are simple banal mistakes. But you pay for other people's mistakes ...

Such a situation is not uncommon. You agree (with a restaurant, catering, hotel, etc.) to pay for the buffet 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 have been ordered and there is an agreement that if 50 is drunk, then the bill will be only for 50. But at the end of the evening it turns out that 75-80 are drunk.

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

Knowing that you are serious and that you intend to control costs can help you overcome the temptation to overcharge.

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

Risk management laws: time and attendance

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

People can come to an event without even letting you know they are going to come.

People are late for events (including speakers).

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

Advice written in blood on the wall of the convention center

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

Have a mobile phone with you.

Have a charged mobile phone and charger with you.

You must have money on your mobile phone bill (that is, so that it is not turned 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 small fraud at events. Note that petty theft is not as harmless as it seems. If you lose something for $ 100 per month, then by the end of the year the total loss will be $ 1200, which is not so little. You could buy a computer or go on vacation.

First of all, inventory accounting is required.

Your team should have a person who is personally responsible for the safety of the inventory (or at least for its timely accounting). He should have a list of all the equipment you are bringing 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 real-time information about losses. You can either find or buy the items you need before the next event.

Roughly the same scheme should work for valuable handouts. 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 another decision is made).

Where possible, number or label the equipment you take to events, from a projector to a pair of scissors. Have a sticker with your address and telephone number on the projector. 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 will not be possible to say that they did not see where this projector should be returned (computer, portable podium, box with important documents, etc.). Likewise, if the company name or owner's name is prominently written on staplers and scissors, it will be difficult to recognize them as ownerless.

If members see you treating this as a special resource, then they will not treat your inventory as an "unspoken gift".

If you distribute, for example, calculators to the seminar participants, they will be very tempted to "forget" to return the beautiful and so useful calculator to the organizers. Someone may not cope with this temptation, especially if he is provided with anonymity. Nobody will check handbags and bags. How to help Clients to act honestly? Number the calculators and write these numbers in front of the names of the participants when registering. Understanding that it is easy to find someone who forgot to return the calculator from the notes helps a lot to be accurate. If the person did not return, he really was mistaken, and you can just very politely remind about this as an easy misunderstanding. Even if you have to remind me ten times.

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

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

Scammers and onlookers

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

Fraudsters also attend various conferences, banquets and receptions - in contrast to the "vacuum cleaners", people with a clear "legend". Usually they pretend to be journalists, employees of large organizations and state institutions - the State Duma, some ministries. They are well dressed and carry on confidently.

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

For example, these people may claim to have registered, accredited to your event, but somehow didn't make it to the list. Or that their organization is solid and does not register for events, but simply sends an employee who "will look and assess 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 a buffet table, get some souvenirs (that is, rob you for 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 the upcoming weddings (prepare: learn about the relatives of the young people) 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 in a romantic state under the influence of a wedding. After all, a wedding is also an event.

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

Look what e-mail is written on the business card: if it is registered on a free hosting, ask why the company was unable to provide a corporate e-mail.

Is the postal address and city phone number of the company recorded on the business card? If not, this 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 confidence that there is a stranger in front of you who asks him to believe and give a little 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 essential for events in which participants are provided with something of material value, for example, during conferences, banquets, buffets. At public events, you most likely will not have such a 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, at a corporate party or on a winter holiday, some of your guests skate. There is some possibility that someone will get hurt. It is ice skating that could be insured.

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

Also be aware of copyright issues for music, videos, and photographs. 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 for participation 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 have sold a TV on credit, then you may not be particularly worried if the Client does not pay. An employee of the department for work with debtors will contact him, and in the most extreme case, the TV will simply be taken back.

The service is intangible - you won't be able to get your job back after the event is over - and the risk of non-payment in the field of organizing events is very significant.

The collection of receivables is handled by 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 on this, there are seminars that teach this work (in our company, for example, 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 be very persistent and consistent in repeating what you owe (person or company).

If possible, personalize the debtor. You should not address the enterprise in an abstract way, but to some 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 is launched if the Client did not pay 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 in person.
On the fifth day - call, remind, ask for an explanation.
On the tenth day - write a written claim according to template number 1: soft, but decisive.
On the twelfth day - call and find out how the claim is progressing.
On the twentieth day - write a written complaint using template No. 2: tougher.

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

For example, if you have not achieved a solution to the problem at the participant level, offer to transfer the solution to the issue to the level of company management. In some cases, for a participant (company employee), this may become an unnecessary complication in relations with management (they are simply afraid of him), and he will make every effort not to bring it to this.

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

Letter of guarantee... Sometimes attendees refuse to pay, denying that they were at the event. To avoid this, ask all participants for whom payment has not arrived to sign a letter of guarantee that payment will be made.

Prepare letters of guarantee in advance. Having this document in your hands, you will be able to contact both the company and personally to the participant who put his signature.

Make it a rule for all participants who have to pay. And don't let them go 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 year
ISBN:	5-902862-14-0
Volume:	320 s.

YOU WILL LEARN:

why you need to manage risks;
what five steps are needed to manage risk;
how to learn to manage risks.

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 a workspace or deciding on the possibility of combining 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 necessary in a situation where there is uncertainty and uncertainty.

In no case should risk management be opposed to current regulatory requirements. It is impossible to justify the non-binding nature of the implementation of legislative norms through risk assessment. The risk management process is the source of requirements. History knows many examples when it would be possible to avoid dangerous situations if we were better with them. managed... There are also many developments in pharmaceutical practice from which lessons have been learned.

This is how GMP 1 rules came into being. These rules are just a program to minimize the known risks associated with drug manufacturing. Preventing cross-contamination, confusion or substitution, hygiene and self-employment, choosing a quality control strategy and maintaining a quality system are just a few of the classic examples of risk management.

Many managers believe that they can 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 tremendous intuition. Only it is hardly congenital. 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 consequencesand because of what can this happen?Good intuition is a “spontaneous” assessment of risks by an individual person. And the conscious application of the risk management process is an objective corporate culture that is weakly dependent on subjective factors. Moreover, it is a replicable and easily distributed technology.

Identifying and assessing quality risks does not work by itself. The result of risk management is the selection and implementation of a strategy for controlling significant risks. The task is not to endlessly play different 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 a medicinal product, the holder of the marketing authorization and government agencies regulating the circulation of medicinal products are responsible to the patient for the efficacy 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 patient safety is to implement an effective quality risk management system. This is an element of our responsibility to society. The patient needs guarantees of the effectiveness and safety of the products he takes.

Security does not mean there is no 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 without 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, at least, will 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, we need to adequately assess them. If you do not study the nature of possible risks and hide behind the slogan: "NO risk is acceptable!" - we will not be able to understand why this or that risk can be realized, 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 essential and essential competence of any manager of any level at any enterprise.

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

Contractors perform work based on the established requirements. Managers, however, 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. It is needed when they are forced to make important and difficult decisions in conditions of uncertainty. For example, there are no legal requirements or these requirements are stated without specific algorithms for their implementation, or there are several implementation options, but there is no certainty which option to choose. Leaders are responsible for the results not only of their work, but also of 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 conclude about his professionalism. If a leader skillfully applies this methodology, he will come across as an astute person with clear logic and remarkable intuition.

These are the qualities that risk management technology develops. In addition, such a leader understands that the executor's mistake 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 their favorite "poke" method, or shift the responsibility for the decision onto another, for example, the same performer. It's easier. The practice of doing only what is required and only as understood is inherently flawed. You must admit that 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 as to how it will affect the quality of the product, and hence the safety of the patient. And then it may seem that risks are something that does not depend on us. Or, conversely, we will become presumptuous to believe that we have completely eliminated risk.

However, in reality this is not the case. Any deviation, failure in the operation of the engineering system or equipment, a complaint received or a signal about a side effect of the drug is a realized risk. Of course, you can simply not register deviations and emerging problems, thereby confirming the reliability of your processes. This is a bluff! There are and always will be risks. 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 how to act if it does happen. To do everything that depends on us and to 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 confident in 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 this or that course 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 making a profit or slow down the development of the enterprise.

The basic principles of quality risk management in the pharmaceutical industry are set out in the ICH Q9 guidelines, the text of which has been incorporated into the European GMP framework since 2008: first in Appendix 20 and then in Part 3 of the GMP. The need for risk management is documented in various guidelines issued by regulatory agencies, professional communities (eg ISPE, PDA, IEST) and healthcare organizations around the world. This methodology is based on knowledge and experience accumulated 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 of ICH Q9 from GOST R 52249-2009 with a “criminal” wording: “ This text is stated vaguely and is not suitable for practical application". Why is it not suitable? The risk management process model presented in ICH Q9 (Figure 1) is simple and, most importantly, action-oriented (Figure 2).

Figure 1. Traditional quality risk management process (in accordance with 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 use this technology correctly, it is necessary create internal standards and procedures, to trainleaders and experts involved, exercise constant supervisionfor the quality of the assessment.

Attempts to exclude risk management technology from the effective decision-making process 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. You cannot go to extremes and blame the technology of risk management for redundancy, incorrectness or subjectivity.

The decision of any person is subjective in nature. You need to fight not with subjectivity, but with carelessness when making decisions. 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 a separate risk category, the so-called missing information.

Likewise, the risk management methodology cannot be elevated to the status of a “regulatory requirement”. Decision making techniques, by definition, cannot be so. This is the same as forcing everyone to think and act according to the same template, which is simply unacceptable and, moreover, dangerous! Risk management is not aimed at circumventing regulatory requirementsand not a direct regulatory requirement(see section 1 part 1 of GMP). The GMP rules declare the need for risk management only in order to emphasize their paramount importance and relationship with the quality system and the rules of proper production and quality control of medicines.

Scheme 2. Algorithm for risk management for quality. Based on ICH Q9 model

GMP regulations require a risk assessment when there is uncertainty. 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, paragraph 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 program to prevent cross-contamination (part 1, clauses 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 justifying the scope of validation work (Appendix 15).

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

Both the successful functioning and the survival of the enterprise depend on the effectiveness of the managerial decisions taken by the manager. It is also necessary to take into account the fact that, in addition to the obvious advantages, the risk management process has serious disadvantages (Table 1).

Table 1

Advantages and Disadvantages of a Quality Risk Management Process

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

You also do not need to 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 a not very large-scale assessment can reveal dozens, even hundreds of different risks. This can be confusing for any specialist, since it is not clear what to do with them and what to tackle in the first place. Of course, it would be nice to eliminate all the risks, but most often it is impossible to do this. Our resources, like money, are always limited, so we have to choose priorities.

It is intuitively clear that some risks require priority solutions, and some are generally not interesting to us. To determine priority actions, it is just necessary to establish the elements of risk - the level of its impact and the likelihood of implementation. If a hazard is realized, it can have a different effect, which largely determines the severity of the risk, just as an assessment of the likelihood of a particular negative event can tell us a lot and predetermine our perception of security.

A-priory, risk- This is a combination of the probability of a particular hazard and the severity of the harm it causes. There is no methodological error here. Indeed, values \u200b\u200bthat are different in meaning are multiplied and a conclusion is drawn from the result. When using two criteria for assessing risk, we are not talking about its averaging.

The probability is taken into account in order to cut off incredible, unreal events. Another question is that we still prioritize based on the level of their impact.

The methodological error lies in the fact that some Russian critics do not take into account the main axiom of risk management: the severity of harm has a higher priority over probability.

Therefore, if, for example, consider the boring example of an airplane, an incorrect gradation of risk when using a quantitative assessment can be considered an error. Consider two events using a five-point scale (1 to 5).

First.Nonhazardous event - late arrival of the aircraft (severity of harm equal to 1), but often repeated (probability equal to 5).

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

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

The first event is an insignificant risk, but the second event can be ranked as a significant risk (due to the fact that the severity of harm coefficient exceeds a certain predetermined threshold, for example, 2), which means that it will require our close attention and development of a program to control such risk, ensuring constant monitoring of its effectiveness. The risk control program can be different - from one action to a separate comprehensive plan.

Embedding the risk management process into the daily life of the enterprise does not require investment and does not imply the implementation of any complex systems and models. It is enough to take just five steps.

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

Second step- you need to learn how to create risk profiles, that is, to systematically determine all the risks inherent in the object of our assessment (draw up a risk assessment protocol). This is important, because it is useful to manage risks “on the spot”, but not enough.

A task third stepis to learn how to determine which risks should be dealt with first. To do this, you need to be able to analyze risks, prioritize.

For successful implementation fourth stepyou need to select and implement strategies to manage significant risks. It is important here to understand what specific actions we need to take in order to gain more and / or lose less.

And finally fifth step- to learn how to create an optimal "safety cushion", that is, to develop an action plan in case one or another risk is realized. The goal of this step is to prepare for any development of events and always have a "B" plan. These are basic steps that apply in any situation, in any business, and at any level of the enterprise hierarchy. The model shown in ICH Q9 is used in most countries in the world. A similar model is presented in the basic ISO 31000 2 standard. Today, there is a serious methodological base for the implementation of the risk management process in the practice of pharmaceutical companies, which has been actively developing since the 60s of the last century. More than 100 risk assessment methods are known. The ICH Q9 guidelines state only six of the most common tools (Table 2), ISO 31000 describes 31 methods, and there are even more in life. However, this does not mean that everyone should be used. You need to select for yourself those risk assessment tools that you can work with and which you will trust. The main thing is that they are clear to you.

table 2

Summary of ICH Q9 Risk Assessment Methods

Risk Assessment Tool	Specialization	Detail of the assessment	Complexity	disadvantages
PHA - Preliminary Risk Analysis				You need to be able to predict threats. Prevents relationships between different threats
HAZOP - Risk and Opportunity Analysis				Requires a lot of information about the subject of assessment. Evaluates threats by components / elements without linking 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 the risks associated with objects / systems
FMEA - Failure Modes and Effects Analysis				Not very useful for retrospective risk assessment. Does not establish a relationship between failures / threats and their causes
FTA - Fault Tree Analysis				May be monotonous and lengthy
RRF - classification and screening of risks				Not suitable for retrospective risk assessment. Of little use with a small number of identified threats

Thus, learning to manage risk professionally requires practice and experience. Naturally, this takes effort and time. 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 any special day, wait for some event or mood. By managing risks, we ensure the quality of our work and, conversely, by ensuring quality, we manage risks. The result of risk management is a guarantee of the quality of your products, compliance with regulatory requirements, a stable profit, and therefore a guarantee of our stability. Modern life insists on this!

Per. from English. VIALEK Group of Companies

1 GMP (Good Manufacturing Practice) - good manufacturing practice (standard for a production management system). - Approx. ed.

Organization of events is difficult and sometimes unpredictable. At almost all events, situations arise when something goes wrong and gets out of control. There are many risks associated with organizing events, and we will talk about them in this article.

Staff

People are always a source of risk. Even if you work with professionals, you shouldn't rule out the human factor. The presenter may get sick, the speakers at the event may not come, the waiters may not be able to cope with the work. You should always have the phones of people who can quickly come and save the situation. Hosting, emergency services and food delivery numbers will never be redundant, and in some cases will help save the whole event from failure.

Equipment may break

Please be aware that the camera or camera may run out of battery, your computer or projector may stop working, or the electricity may go out altogether. Such situations should always be foreseen. 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 at what moment they may be needed, but in case of force majeure, they will help you a lot.

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

Speakers at conferences

Check in advance the invited speakers for the presence of public speaking experience, otherwise you may find yourself in a situation where the speech becomes a failure due to the speaker's lack of experience. In this case, rehearsals before the event will save you, which will help prepare an inexperienced speaker for the stage and save you from unforeseen situations.

Abrupt weather changes

There is always the possibility that at the most unexpected moment it will rain or a thunderstorm. 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 at this time you can occupy the people who have gathered for the beginning of the holiday.

Guests may not behave as planned

In the event manager's plan, everything that should happen at the event is clearly spelled out: 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 the request to go somewhere, because they are too keen on 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 the timing and how complex the event is.

Material prepared:

Great events. Event management technologies and practice. Shumovich Alexander Vyacheslavovich

Main risks

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

In order for this not to happen, 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 failure to comply with them.

There are risks associated with participants. At events, adults with a college degree often start acting 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 unfamiliar surroundings), they intensively lose their own things, accidentally take strangers ... This is not their fault, so this factor must be taken for granted and taken into account in work.

Required qualities of an event organizer:

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

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

– friendliness. Whatever happens, your guests are your Clients, and you need to treat them as friendly as possible;

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

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

– "paranoia". Be always on the alert.

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 - THIS IS NORMAL in our business. In the sense that this is the norm.

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

You need to have a backup plan for each potential problem. Least psychologically you must be prepared for anything. Your rescue plan may not compensate for the losses, but the event will not completely fail. Someday this approach - preparing a fallback - will save you. This is professionalism.

Computer risks when holding an event, it is worth considering separately.

We have a spare set of necessary equipment, which we “senselessly” carried to every major event for several years. And at one of the conferences our computer burned out right during the presentation. He sparkled, went smoke, 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 and reported what had happened to the “problem solving table” by walkie talkie. It took a few minutes to change, the presenter only missed a couple of slides.

For ten years nothing like this has happened. 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, the logistics system, from the process of movement of goods to the processes of moving orders in the market space, covers a large number of diverse aspects, work

From the book Project Management Fundamentals author Presnyakov Vasily Fedorovich

From the book Innovation Management: A Study Guide author Mukhamedyarov A.M.

From the book Business plan 100%. Strategy and tactics of effective business author Abrams Rhonda

From the book Work as Spies author Carlson J.K.

Cost risks Most of these risks are the result of errors and omissions made in scheduling and technical

From the book Project Management from A to Z author Newton Richard

Price protection risks. Projects that have a long period of time need to provide for measures in the event of price changes, usually increases. When revising prices, avoid using one large amount to cover all price

From the book Business Informatization. Management of risks author Avdoshin Sergey Mikhailovich

Technical risks Technical risks are problematic and can often lead to project closure. What if the system or process does not work? Contingency plans or back-up plans are made where there are

Having a list of works, arrange them in a logical reverse order, starting from the day of the upcoming event until now.

List the key dates. These are a kind of checkpoints - checkpoints, in which it is checked how successfully the plan is being executed. On these key dates, the main events for the preparation of the event should take place.

Check how the dates fit into the calendar, take into account holidays, weekends, etc. See how the dates fit into the company's plans as a whole.

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

The plan is ready, proceed with its implementation.

Consolidation of the components of the plan into one whole.It is also important that the components connect together. 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 that are 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, “Oh, kay.” The booklet has all the raw materials, and there seems to be enough time to complete the assignment. At this time ... You agree with the printing house that on Friday morning, 4th, you will have a layout and you

ready to submit it to print. The print shop prepares, plans the press load times, the time at the repro center for color separations, etc. If you miss the time, it will be given to another customer and you will have to re-enter the queue.

The printing house promises that it will print the booklets in four working days, that is, on Friday night, the 11th, you will have a booklet. This is normal, because on Monday the 14th, your exhibition opens, where you bought a stand and paid $ 5000 for it, agreed to meet with several very important customers, hired promotional staff to distribute brochures ... 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 his speed and the budget is ten times higher than the cost of his work, the performer treats his work more responsibly, he understands motivation and understands why they are required of him hand it over today, and not another day.

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

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

Problems

Risk management of events

The main thing is that all these problems, problems, problems and complete disasters are not noticeable to the participants. And the more they did not bother them in any way Moreover!

A good organizer is obliged to anticipate all possible adverse situations and prepare for their solution 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 practically not have the opportunity to replenish stocks, fix breakdowns, etc. Therefore, they take with them everything they need, with a margin, given that things break, tear, wear out. They have spare pairs of socks, pans and much more ... Events are organized in much the same way. It is important to foresee everything, to be corrosive,

attentive, scrupulous, planning everything carefully and not forgetting anything.

Main risks

The main risk is associated withfailure of your own plan. It may turn out that a well-designed scenario, systems of measures to prevent problems, etc., simply will not be implemented by your subordinates.

There are risks associated with participants.At events, adults with a college degree often start acting 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 unfamiliar surroundings), they intensively lose their own things, accidentally take strangers ... This is not their fault, so this factor must be taken for granted and taken into account in work.

Required qualities of an event organizer:

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

Friendliness. Whatever happens, the participants are your guests, and you need to treat them 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 solution; Competence. Knowledge of your event and all its constituent parts, experience, attention

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

"Paranoia". Be always on the alert.

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 - THIS IS NORMAL in our business. In the sense that this is the norm.

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

You need to have a backup plan for each potential problem. At the very least, psychologically you must be prepared for anything. Let your rescue plan

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

- preparation of a fallback option - it will save you. This is professionalism.Computer riskswhen holding an event, it is worth considering separately.

Event errors

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

As for the beginning, most often the flaws are associated with 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

getting smaller; the organizers have a feeling that everything is going well and the most difficult thing is behind. And this is also a very dangerous moment. People relax, which means 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 staff are especially collected and attentive. A brilliant end to the event will help leave a brilliant impression.

Safety margin of the event

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

Many of these decisions will have financial implications, and this should be understood. If the manager, being on the spot, made some decision that entailed expenses, he cannot then be reproached for this, and even more so with a fine. If you delegated authority to a person you trust, you must believe that he made the best decision that he could make in those conditions, having the information that he had.

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

Consider duplicating functions throughout the project. Something unexpected may happen to each of us, and a temporary replacement may be required. Let each team member have one or two understudies who, at least in general terms, are aware of the tasks and problems existing in this area of \u200b\u200bwork, and, if necessary, can 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. Leverage your experience: document it and share it with other employees so they can get it right on the first try. It's amazing how often situations and problems recur.

Experience is an opportunity now from the first attempt to do everything right.

Best compliment I've heard:

“Your events are boring. They are somewhat similar to Lexus. Everything works like a clock, nothing breaks and looks great. "

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

Ethics

An example of internal risk. Is what you are doing right? If you don't know if you are doing well or not, apply the classic ethics test used in the West. Before you take this or that 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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