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At the time of the audit, I will only review it like this: For clause a: ask the organization how to obtain information that expresses the characteristics of the product, and usually look at:
Production Task List", "Drawings", "SOP" and then combined with on-site observation to ask whether it has taken over the above: "Production Task List", "Drawings", "SOP" and other documents. For clause b:
Go to the site to check whether there is a work instruction for the post, ask the operator whether he understands the content of the work instruction and whether he is in accordance with the SOP regulations for clause C: go to the site to see whether the production equipment can meet the production needs and customer requirements, in order to judge whether the production equipment is suitable (but I am a little confused, how to judge whether the production equipment is suitable, is it just an observation and inquiry?). And the equipment mentioned here does not refer only to "production equipment", not to:
Detection equipment) for clause d: on-site inspection of the organization's equipment: monitoring and measurement equipment, whether monitoring and measurement are implemented, whether it can meet production needs and customer requirements, (this clause is also by asking observations?)
For clause E: check whether there is implementation monitoring and measurement on site, check the implementation record (this clause should be able to be reviewed together with clause D) For clause F: product release:
Inquire to view: the requirements for the release of the product, such as the inspection can only be released after passing the inspection, or approved by an authorized person, if necessary, the customer approval is required to release the delivery: ask the organization how it is delivered, the delivery process, such as the way of delivery by the organization after inquiry:
By delivery note, hand it to the customer, ask the customer to sign for the post-delivery activity: does the audit trail write like this? Such as:
After inquiry, it was learned that the organization will have professional quality customer personnel and business personnel to maintain contact and communication with customers at any time to ensure that the product problems after delivery are solved in a timely and effective manner, and further understand that there are recent customer feedback on the poor quality, the organization has taken necessary measures to solve it, check the processing records, all of which are implemented and effective, so the above products are put on, delivery and post-delivery activities are planned and run under controlled conditions, basically meet the requirements above, I am a novice, the writing is not comprehensive, relatively superficial, Please advise you!
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The whole ISO 9001 standard, probably the most difficult to understand. I saw that some enterprises did not meet the non-conformities in the external audit, and there were many non-conformities.
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I have a suggestion, you first understand and understand, and the rest is enough.
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Control of production and service provision.
Organizations should plan and carry out production and service delivery under controlled conditions. When applicable, controlled conditions should include:
a) Obtain information that expresses the characteristics of the product;
b) Obtain work instructions, if necessary;
c) Use of appropriate equipment;
d) Access to and use of monitoring and measurement equipment;
e) implementation of monitoring and measurement;
f) Implement product release, delivery and post-delivery activities.
Key points to understand: 1. The organization should plan the production and service provision, including all factors that affect the quality of the production and service provision process, such as man, machine, material, method, environment, and measurement, so that it is under the expected control state.
2. The production and service provision department should obtain the relevant information that expresses the characteristics of the product, such as product specifications, drawings, color codes, packaging requirements, service specifications, etc., and clarify the product requirements that the product needs to meet.
Key Audit Evidence:
Evidence of the effective planning and implementation of the production and service provision process, including: relevant documents or information describing the characteristics of the product, work instructions and specifications for the necessary products or services; Evidence of the equipping and suitability of production service equipment and monitoring and measuring devices; evidence of monitoring and measurement of production and service provision activities; provisions for release, delivery, and post-delivery activities and evidence of their implementation; Evidence of the use of computer software for the provision of production and services, confirmed and approved;
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This "control of production and service provision" is one of the steps required in the process of product realization, when product planning, customer-related processes, design and development, and procurement are all completed.
That is, "everything is ready, only the east wind is owed", the idea, the confirmation with the customer, after the procurement process, in the process of production, the enterprise needs to plan and implement the required resources, to ensure that the resources are sufficient and applicable.
This resource includes: Product Information - Product Characteristics Information, Work Instructions - Depending on the actual situation, not all positions may require Work Instructions. Here's an example:
Doctors do not need to give instructions for injections. Again, if the position, no newcomer will make mistakes, and there is no need to give work instructions, but the positions that will affect the quality of the product need to be cleaned work instructions.
Equipment - Ancillary equipment is required for any product production. Monitoring and Measuring Device - In the production process of the product, the product is completed, and there is a measuring device to monitor the process parameters and product performance indicators. In the early planning of the product, it is necessary to define what to measure, how to measure, what measuring instruments and equipment to equip.
Monitoring process - When the testing equipment is complete, the monitoring is carried out according to the frequency method of the intended plan. Release, Delivery, Post-Delivery - After the first 5 articles are over, there are the issues after the product is produced, how to release it, how to deliver it to the customer, and how to provide the service after it reaches the client. These need to be clearly defined.
As a reminder, when a problem occurs, don't put it lightly, you need to ask a few more questions, and find out the most fundamental problem in the ** section. For example, if the calibration of the monitoring equipment is expired, it is placed in the enterprise that has the equipment, but there is a problem in the process of control. The homework documents are not detailed, nor are they, because, during the training, the teacher emphasized that many problems at first glance seem to be product and service provision problems, and some auditors are jokingly said to be auditors.
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It is the control of production and service provision, which is a specific description of this big clause, which includes the control of product information, planning, production and service process, use of equipment, monitoring methods, identification, delivery and other processes; It is the confirmation of the production and service provision process (note that it is a confirmation, it is a control process), and it is an evaluation of whether the ability of the process (each sub-process, process) (including people and equipment, etc.) meets the process requirements, especially for those "special processes".
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I feel that one is talking about the documents, standards, and requirements that you want to establish, and the implementation of what you have established before, that is, the records.
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It is a request for the confirmation of a special process.
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As we all know, quality management system certification is the basis of various certifications of enterprises, and the revision of the new version of the standard makes it more widely applicable.
ISO9001 quality system certification.
Especially in recent years, with the rapid development of emerging industries and service industries, quality management system certification is no longer limited to the traditional product manufacturing industry, and the emerging service industry has also become the main force of quality management system certification.
In order to accommodate this development, the standard no longer emphasizes "products" but "products and services".
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Correction: Supplemental internal audit, improvement, audit evidence.
Reason analysis: The reason why the internal audit lacks clauses may be that the audit plan or the plan itself is imperfect and lacks clauses; Or the internal auditor (team) itself is negligent, and the internal audit team leader does not check in detail.
Corrective measures: 1. Training of all members of the internal audit team to deepen the understanding of the integrity of the internal audit, 2. Improve the internal audit plan (audit plan) for the coming year.
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The following records may be used as evidence in "e)".
The device monitors and measures the results of the slow side--- such as the actual temperature, time, and pressure of the chemical plant, the charging record, the security check record of the station, etc.
First Article Inspection Record--- There is a lot of evidence that auditors list the first article inspection record as "", which I thought was inappropriate.
This is because the "purpose" is to monitor and measure the characteristics of the product in order to verify that the product requirements have been met. The "first inspection" is qualified, and it cannot prove that the products produced in the future are qualified. solid can not be disturbed by the oak as evidence."
The "first inspection" can confirm that the process combination ability to produce qualified products is satisfied, and the first inspection is qualified, as a necessary condition for continued production. This is clearly a means of production control, and it is more accurate to list the first inspection record as evidence of "e)".
Semi-finished product inspection records--- semi-finished product inspection is also a means of production control, so it can also be used as evidence in "e)", and it can be clearly stated in the audit record that "specific evidence is detailed in "see "in". In addition, self-inspection records and process flow sheets can also be used as evidence.
Patrol --- inspection records can be used as evidence of surveillance. and the work logs and construction logs of production management personnel at all levels.
In some enterprises, a process flow sheet is used, which includes the variety, specification and model, batch number, process requirements (such as temperature, pressure, and time of specific lead content), monitoring records, and records of abnormal production conditions. This kind of process flow sheet can also be used as evidence of ")e)". This kind of process is both a document and a record.
The production instructions (plans) and process requirements as documents shall be approved. ”-
This auditor, in his opinion, should be.
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The internal audit is mainly based on the standard internal audit plan for each department, verifying the information of each department, sorting out the internal audit results, and obtaining the internal audit report.
The internal audit plan is listed and broken down according to the standards.
Determine the internal auditors, who must hold the internal auditor certificate.
Convened the first internal audit meeting.
Conduct internal audit of each department, and the leaders of each department will issue internal audit plans and reports.
Hold the last meeting, rectify the problem, and report to the leader if there is no problem.
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Product planning and production control process: this ** is filled in by the quality and safety management department;
Production facilities and environmental management process: jointly completed by the production workshop, equipment management, and safety and environmental protection department.
If you are not a front-line administrator of production, what you fill in is not true, this form is required to be completed by the relevant departments and submitted to the internal auditor for approval.
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Are there trained internal auditors?
In general, if there are tutors, ask them. Everything is understood.
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Now both. Be.
ISO9001:2008 version. Go to the library. And you can get it off for free. This writes.
Not so many words. There is a need to add me. I'll send it to you.
Sanlian Hengxin. Stay.
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