How to prepare for external audit

Correctly treat external audit

1. 1

Every audit has a purpose. For example, accept third-party audit, pass certification, and obtain certificates; Accept the audit of the second party (customer), hoping to become their supplier, or for other purposes. The preparatory work must be carried out around this purpose.

1.2

Establish and implement a system that meets the requirements. The premise of passing the certification and obtaining customer recognition is to actually establish a quality management system that meets the standards, corresponding laws and regulations and customer requirements, and the organization should prove its ability to provide products and services that customers are satisfied with. Therefore, we should use objective evidence to prove that we have the ability to effectively implement this quality management system.

1.3

Actively demonstrate their abilities. No matter what the purpose of the audit is, welcoming the external audit is an opportunity to show your ability. We must treat it correctly, especially the nonconformities found in the audit. Unqualified is not a good thing, but it can become a good thing. Understand from the front. Because it does not conform to the objective existence, if it is not found and corrected this time, it will always bring greater losses in the future than now.

1.4

Actively cooperate with auditors to do a good job in auditing. Successfully completing the audit is the common task of the auditor and the auditee. Audit is a systematic, independent and documented process of obtaining audit evidence and objectively evaluating it to determine the degree of compliance with audit criteria. The auditor hopes to obtain sufficient evidence from the site as soon as possible, so as to believe that the quality management system of the audited party conforms to the audit criteria and is effective; The auditee shall actively display all kinds of evidence in line with the audit criteria to prove that the system it has established meets the requirements of the criteria and is effective in implementation.

How to do this work well, mainly grasp the following aspects:

2

Explain the purpose and scope of this audit.

The management representative and the person in charge of meeting audit must know and determine the following information as early as possible in advance:

2. 1

The purpose of the audit. Is this audit certification, second-party audit, or other purposes?

2.2

Auditing standards. Different auditing purposes should adopt different auditing standards. Generally, system documents and product documents such as quality management system standards, self-owned manuals and procedures, as well as contracts signed with customers and applicable laws and regulations are all audit criteria. However, different audit purposes have different emphases. For example, second-party audits focus on requirements related to their products. Third-party audit focuses on process and customer requirements.

2.3

Audit scope. Determine the location, function and product scope of the audit.

2.4

Number and grouping of auditors. Usually one week in advance, you will receive a written notice from the auditor including the above aspects, so you can make full preparations.

three

Organization and implementation

3. 1

The company level decided to escort.

The company shall provide an accompanying person for each auditor of the certification body (customer). This person should be familiar with code, company organization, division of labor and business, and have certain communication and expression skills. Responsible for communication within the company and with relevant functional departments. Usually served by experienced internal auditors.

3.2

Specify the audit objects at all levels.

According to the division of labor in the matrix diagram of the quality manual, the units, departments and groups related to this audit should designate an auditee in advance (usually the supervisor or the main backbone of the department to cooperate). If necessary, designate another alternate. In case the receptionist can't receive or answer for any reason, the standby is at the top. The task of the auditee is to try to show the evidence that the competent department meets the audit criteria with objective evidence and prove that the system is effective. Mainly:

3.2. 1

On behalf of units, departments and groups, according to the audit plan, select and prepare typical evidence materials in advance, including documents, records, physical and on-site introduction and reception. Take the initiative to provide it when accepting the audit as objective evidence to prove the compliance and effectiveness of your system.

3.2.2

Answer auditors' questions on the spot and provide objective evidence. Meet the requirements of auditors.

3.3

Training of accompanying personnel and auditors

3.3. 1

Inform the above personnel in advance to review the plan and do simple training. Time does not exceed 1 hour. If you have any questions, please ask them in advance and make training records for the training.

3.3.2

Let's unify the division of responsibilities again. Who is responsible for providing evidence on behalf of the company (the department in charge of the intersection of rows and columns in the matrix table). Who is in charge of which functional department. Check for yourself whether these objective evidences can fully prove the conformity and effectiveness of the system.

3.3.3

As for communication, in fact, when establishing the system, the contents of Article 3.3.2 above in this document have been made clear. It is only a temporary re-emphasis and reminder to achieve the purpose of communication. At the same time, let everyone know each other's communication methods and information, such as office location, landline and mobile phone number, so as to communicate effectively.

four

Ideological mobilization to meet the inspection

4. 1

Let employees know

At the right time, let the employees of the whole company know what audit will be accepted in a certain period of time in a certain way.

4.2

Know how to receive

4.2. 1

Each employee (at least the employees who are on the job at the time of audit, including managers and technicians) is required to determine their scope of work. Prepare the contents of the previous article 3.2. For example, you can answer the work you are responsible for and the documents you execute, and explain what your work has to do with the achievement of the company's quality objectives. Select typical evidence materials to prove that your work meets the standards, regulations and customer requirements and achieves the target requirements. Prepare the evidence provided in advance. What evidence can you provide when the auditor asks you to show it? For example, standards, company documents (procedures, work instructions), records, etc.

4.2.2

What questions are expected to be raised during the audit? How to answer.

4.3

Every employee should be able to answer some questions.

Every employee may be audited. Therefore, in addition to preparing questions about the scope of his work, he must also identify some issues that need to be recognized. Should be determined according to the purpose of the audit, such as:

4.3. 1

Article 5.5.2.c) of ISO900 1 standard requires "to ensure that the whole organization's awareness of meeting customer requirements is improved". Employees should know what they are doing. What are the requirements of this job? What files are executed?

4.3.2

Article 6.2.2.d), "Ensure that employees realize the importance and interrelation of their work and how they can contribute to the realization of the company's quality objectives." Employees should know who is the recipient of their work. Who are the external and internal customers? What is the key in my work? Measure what goal? What kind of situation has it reached? How can I meet these requirements? If it is not done well, what consequences will it bring to customers.

4.3.3

If it is TS 16949, employees should also understand some basic concepts of statistical technology in combination with their own work. For example, what is deterioration, the common and special causes of deterioration, and what is excessive interference and insufficient control. It is best to explain it with practical examples of previous work.

4.3.4

Let employees know that not all questions raised by auditors must be answered. Employees only need to answer some questions about the company's general quality management system, such as quality policy, the relationship between work and company goals, and issues within the scope of responsibilities. When being audited, everyone will work normally in this position. Welcome with a smile. Auditors should answer questions politely and realistically. But only answer what you have done or what you have been responsible for. Tell him other questions politely. This is not my responsibility. If you ask again, politely tell me to "ask my boss" or be assisted by an escort.

five

Meet the audit

5. 1

First meeting. On the first day of normal audit, the first meeting will be held in less than half an hour. Presided over by the auditor. The company's top managers, management representatives, receptionists and accompanying personnel of all related functions should attend. The positions and names of the participants in the meeting shall be submitted to the other party in writing as evidence.

5.2

Perform the audit as planned. Every department is received by a receptionist. Evidence that needs to be provided by other departments shall be provided in time through communication with the accompanying personnel.

5.3

Find out the inconsistent facts. If the auditor thinks there is nonconformity, what is the objective fact of nonconformity? According to what audit criteria, it is said that it does not meet? It is convenient to take corrective measures.

5.4

Communicate how to close non-conformance report before the last meeting. It is necessary to discuss with the auditor the root cause of nonconformity, the plan of corrective measures, the planned completion date (no more than three months), and what objective evidence can be provided to close the nonconformity report after the implementation of corrective measures.

5.5

Internal auditors can take advantage of opportunities to learn from external auditors and improve themselves.

six

Several specific problems

6. 1

It is suggested that company leaders should not put any pressure on employees. Don't make some policies related to personal interests. For example, who eats it that does not meet the report, what will happen, what will happen, and even punishment. Practice has proved that whenever employees encounter such pressure, they often cover up nonconformities. As long as it does not conform to the objective existence, problems will occur in the future, and the result may cause great losses. It should be recognized that most of the reasons for employees' poor work are not individuals, but systems. Including quality accidents caused by the ability or negligence of the parties, the main reason is the system, not the individual. It is a personal reason, which can be traced back to the fact that the system did not put the right person in the right position, and it is still worth improving.

6.2

Maintain a daily state. This should not be regarded as a special arrangement. If you have established and effectively implemented the quality management system, no one needs to make any "emergency" preparations, such as accompanying personnel and meeting each other's requirements.

6.2. 1

Do not make special arrangements for cleaning. Because, you are usually so clean and tidy; There is no need to put up any slogans, which means there is no special arrangement. Let customers and authenticators believe that this is the real situation of the system operation they want to see.

6.2.2

You don't need to write any special files. More should not write false records, false documents. The leader arranged to do this, hinting at his subordinates, or he could do this to you and cover up his mistakes. If you do this, you will have a big accident sooner or later. The result is often self-harm.

6.3

What should I do if I find that the system does not meet the requirements shortly before welcoming? There should be channels for the company's system. For example, in the standard 8.5.2 "Corrective Measures" procedure and 8.5.3 "Preventive Measures" procedure, employees should know how to ask questions or put forward reasonable suggestions for improvement. Or, the company can arrange some focused internal audits, issue non-conformance report for nonconformities, take corrective measures according to the standard requirements, make plans and implement them as planned. In the process of external audit, as long as the plan is implemented as scheduled, the external audit should not issue a non-conformance report. For nonconformities, don't assign subordinates to take improper measures and should be audited externally, let alone advocate fraud.

6.4

What should I do if I find that I am not fully prepared? After showing an immature system to others, it is difficult to save a bad impression by spending ten times as much energy. If possible, request an extension of the review time.

6.5

What should I do if I have different views on non-compliance? First of all, we must identify objective facts. Consider whether further objective evidence can be provided to prove compliance. If everyone agrees on the objective facts, they disagree on whether they meet the auditing standards. Respect each other and don't argue too much. You can sign the auditor's nonconformity report first. Afterwards, we will put forward opinions or even complain to the certification body where the auditor is located, asking them to make a new judgment.

6.6

Don't miss the opportunity to learn.

6.6. 1

Independent third party audit. Usually, external auditors are more experienced than us, so we should take this opportunity to ask them for advice. Certification bodies generally don't tell you what you should do to meet the standard requirements. Doing so violates the principle of fairness in authentication. However, we can ask them how to correctly understand the standard requirements. Especially when non-conformities are found, the plan for taking corrective measures can be refined to facilitate the closure of non-conformance report.

6.6.2

Audit the second party. We should take this opportunity to understand the needs and expectations of customers in order to meet their requirements.

seven

Try to pass the inspection once.

What do you mean by "passing the first inspection"? For example, the inspection found some problems. No matter how big or how many problems there are, auditors usually discuss them with the company and give them some time to take corrective measures. Generally speaking, the maximum time allowed is three months. Let the auditee close the unqualified items after improving the system. You can usually prove the effectiveness of corrective measures by mail or to a certification company, and then recommend the certificate.

If the inspection finds major systemic problems, the certification company may come again, not counting as "once". This way, the company not only spends a lot of money, but also has a bad reputation. Will lose customers' trust in the quality of the company's products. If you continue, the order will be transferred to other companies. Without customers, the company can't survive. Therefore, whether the audit can be passed at one time is related to the vital interests of the company and employees.