INTRODUCTION
After having written and published on this website the article entitled "Concept of Quality and Importance of Implementing a Quality Management System"; Many people have written to me asking what do I do to implement the System? Well, I start the publication of the first of a series of articles aimed at showing entrepreneurs easy and uncomplicated ways of implementing a Quality Management System in their company and that they are valid for any type of organization, regardless of activity. economic, the type of business to which it is dedicated or the size of it, but I make a suggestion to the reader and it is to read the first article published, since it will serve as a basis to understand the approaches that I make here.
I will publish the articles in accordance with the ISO 9.001 standard, but prioritizing the interests and concerns of businessmen.
For this reason and due to the fact that there are many defective products that are currently on the market causing inconvenience to customers and economic and credibility losses in companies, I have selected for this first article the topic regarding CONTROL OF NON-CONFORMING PRODUCTS.
To carry out my proposals, I have relied on two of the ISO 9,000 family standards; which are the ISO 9.001 standard that deals with the requirements of a Quality Management System and the ISO 9,000 standard that deals with the fundamentals and the vocabulary used in said system.
I have divided the article into two parts, the first, covers everything related to the treatment of non-conforming products and the second talks about actions to avoid product non-conformities.
For a better assimilation of the system implementation methodology proposed here, I will create a fictitious company called "INSTITUTO AUGUSTO" dedicated to offering training courses, this company annually serves about 10,000 students (clients) who attend the training actions that the institute offers and at the end of the course development they receive a “certificate” that supports the training they received. Because it is a highly prestigious institute and due to the high volume of clients who study there, it has a software (computer program) where all the information regarding the people receiving training is registered and captured; and it is through this software where the certificates are made,But the organization has a big problem and that is that a large number of these "certificates" reach the customer with defects, most of them due to errors in the first and last names or in the student's identification number. (The equivalent case in any other company would be defective products that arrive daily on the market); At the institute, the defective certificates that are delivered each year could be estimated at around 1,000, which causes serious inconvenience to the client since they have to wait several weeks for the certificate to be re-prepared when they sometimes urgently require it to present it as support in job search.Inside the institute, no system has been implemented to avoid these errors and everything is left to the discretion of the employees in charge of the certification process.
Since what it is about is that you in your company do a process similar to the one that I propose in this article, a series of suggestions will appear between paragraphs and in a box.
Tip 1. Every company produces a series of products that are sometimes simple and other complex; select a product of your company with which you have problems; If the product is very complex, that is, it is made up of multiple components, for example a bicycle, then choose one of those components to carry out the exercise, bearing in mind that to elaborate a complex product, it is most likely that each component must be manufactured separately.
PART I
TREATMENT OF NON-CONFORMING PRODUCTS
Here a first question arises What is a nonconforming product?
We are going to define it taking as reference what is established in the standard.
In the first article I wrote about the concept of quality, I said that a product has characteristics; and that in order to be considered of quality these characteristics must correspond to previously established requirements, and the ISO 9,000 standard defines the concept of “non-conformity” as “non-compliance with a requirement”; therefore, a nonconforming product is one that has one or more nonconformities, that is, it does not comply with one or more of its requirements.
Suggestion 2. Explain to the people who are directly related to the quality of the product (in this case those who produce the certificate or the product selected by you) the concept of product non-conformity and non-conforming product.
If we are already clear about what a nonconforming product is; So what should I do when in my company without intending to, I end up making non-conforming products?
The ISO 9.001 standard in number 8.3 entitled “CONTROL OF THE NON-CONFORMING PRODUCT” says the following: “The organization (in this case the INSTITUTO AUGUSTO or if your company wants it) must ensure that the product that does not comply with the requirements, (the one we have selected because it has problems, in this case the "certificate") is identified and controlled to prevent its unintentional use or delivery
If we compare what the standard requires with what happens in the "AUGUSTO INSTITUTE" we see that none of this is done, nor the product that does not comply (in this case the certificates with errors) are identified and much less controlled to avoid that they reach the client's hands; in short, there is no correct treatment of the nonconforming product; The same comparison can be made in your company with the problem product selected by you.
Then then to implement this part of the Quality Management System, that is, the part corresponding to the treatment of non-conforming products, we must develop the following steps that I will explain in detail:
1. Identify non-conforming products.
2. Give non-conforming products the appropriate treatment according to the interests of the client and the company.
3. Take actions to prevent nonconformities from occurring in the products we make in the future.
Carrying out the previous steps automatically leads to the control of non-conforming products as required by the standard. Let us now explain in detail each of the steps.
Step 1: Identification of non-conforming products
Let us then proceed with the first step, that of identifying nonconforming products and recording the nonconformities found.
To carry out this step it is required as a fundamental input to have previously identified what the product requirements are, taking advantage of the fact that the ISO 9.001 standard in its paragraph 7.2.1 asks for the following:
"The organization must determine:
- The requirements specified by the customer, including the requirements for delivery and subsequent activities, Requirements not established by the customer but necessary for the specified use or for the intended use, when known, Legal and regulatory requirements related to the product, and any additional requirements determined by the organization ”.
The above components all become the product requirements together.
As we can see, in order to identify non-conformities and therefore non-conforming products, it is necessary to have as an input the list of product requirements; for which we suggest using a table similar to the one that appears below.
| INSTITUTO AUGUSTO LIST OF PRODUCT REQUIREMENTS
PRODUCT___Certificate of approval of the course_ Format RP-1 |
|
| CODE | REQUIREMENT |
| one | The student's names and surnames must be correctly written |
| two | The identification document number must be correctly written |
| 3 | The data that appears on the certificate must be legible |
| 4 | The certificate must have the name and signature of the person responsible for the certification |
| 5 | The certificate must be prepared in the format assigned for this purpose |
| 6 | The certificate must be delivered on the date agreed with the client |
| 7 | The printing of the certificate must be complete |
| 8 | The format where the certificate is printed must be in good condition |
(FORMAT 1)
It is advisable that this table be in view of the person responsible for making a certain product in such a way that it clears any doubts about the requirements that the product must meet, in this case the "certificate".
Tip 3. Create a table like the one shown above where the requirements that the product selected as an example must meet appear.
Explain to the person who carries out activities that are directly related to quality what is the usefulness of this table.
Require the person working on product development to post this box so that they are clear about what the customer and other interested parties expect from the product.
As we are already clear about what a nonconformity is and we have explained it to the person responsible for making the product; and we are also able to detect and identify a non-compliant product (as required by the standard) the procedure to follow is to compare the characteristics of the product with its requirements and thus detect how many nonconformities a certain product has.
But the standard also requires the following: "Records must be kept of the nature of the non-conformities and of any subsequent action taken, including the concessions that have been obtained."
To continue with the case of certificates, we present as an example the non-conformities detected in two of the certificates produced, and to comply with the requirement of the standard regarding registration, we will use the following table where all the non-conformities found in a product, its nature, the date on which the non-conformity occurred and the person responsible for making said product.
As we said previously, we have recorded in the table the non-conformities found in two of the certificates; the certificate identified with number 14 (this code is assigned by you) prepared on April 18, 2005, and the certificate identified with number 5 prepared on April 20 of the same year.
For the design of this second format, the number of rows it will contain is assigned by you, each of the numbers that appear in the box and that are from one to eight correspond to each of the requirements established in the first format in the order in which they appear, I refer to the table “list of product requirements”.
This format 2 must be adapted to the specific needs of your company by adding the fields that you consider necessary.
(FORMAT 2)
For the first example, we find that in the certificate identified with number 14, the operator found two nonconformities; The first one that there was an error in the first and last names which in the “list of requirements” box corresponds to requirement number 1 and the second non-conformity is that the certificate will not be delivered to the client on the scheduled date; precisely because this implies doing it again and this takes time and that in the “list of requirements” box corresponds to requirement number 6.
In the second example in the certificate identified with number 5 two non-conformities appear; The first has to do with an error in the number of the identification document and the second non-conformity is that when printing it, the printer's ink ran out so the printing was incomplete, that's why the numbers 2 and 7 have been marked respectively.
As the standard requires identifying non-conforming products, we suggest using a sticker where the product code appears, the date on which the non-conformity occurred, as well as the possibility of using a color that identifies the nature of the non-conformity, for example the number one red, two blue, three yellow, four green etc. you assign this symbology.
It is also suggested that nonconforming products be placed in a place where they can be easily detected.
Tip 4. Make a table like the one explained above where the product code appears, the nature of the non-conformities detected, the date the product was made and other items listed there.
Explain to the person who carries out activities that are directly related to the quality of the product what the usefulness of this table is and how it should be filled out.
Having established a mechanism to identify nonconforming products, and recording nonconformities including their nature, we proceed to the next step recommended by the standard; the one to give the suitable treatment to the nonconforming products.
Step 2: Treatment of nonconforming products
Here the ISO 9.001 standard asks for the following: “The organization must treat non-compliant products in one or more of the following ways: and from here the standard provides us with a series of options that we must use according to the interests of the client and those of the organization.
Let's look at the following options in logical order:
Option One. Do nothing to the problem product and leave it with the nonconformity (s), but do not discard it either; and for this the standard proposes the following global action: Authorize its use, release or acceptance under concession by a relevant authority and, when applicable, by the customer.
In this case, the specific actions proposed by the standard are:
- Permitted deviation: Authorization to deviate from the originally specified requirements of a product, before its realization.
As an example we could mention the case of a product that initially had the requirement to do it with rounded edges, the company thinking of using a certain equipment, but when starting the manufacturing process, the equipment broke down so it is time to make it in another that throws us some rounded corners. In this case, it is the responsibility of communicating the inconvenience presented to the client and convincing him to accept the change in requirement (non-rounded corners). If he accepts it, we would be using the figure of the “allowed deviation”.
- Concession: Authorization to use or release a product that does not comply with the specified requirements.
Here we could take the production of dark red disposable cups as an example, but when manufacturing them due to an error in the color mixing, we ended up producing light red cups. If we expose the case to the client and he accepts the product, we would be before a concession.
- Reclassification: Variation of the class of a nonconforming product, in such a way that it complies with requirements that differ from the initial ones.
Here we can cite as an example the manufacture of a thread to produce highly resistant clothing, overalls or jeans for example, but due to internal circumstances, a thread was produced that is only used to make clothing that will not be subjected to great resistances. The product itself is not in accordance with the initially specified use, but meets the requirements for a similar use (in this case, clothing production).
Option Two. Leave the product with the non-conformity and dispose of it, which classifies the standard as: Take actions to prevent its originally intended use or application.
Here the only alternative that the norm shows is the waste, either through the destruction of the product or its recycling.
- Disposal: Action taken on a nonconforming product to prevent its initially intended use.
In the case of the certificate that presents errors in the first and last names or in the number of the identification document, the only alternative apart from preparing it again is to destroy it.
Option Three. Correct the detected nonconformity and that the standard defines it as follows: Correction: Action taken to eliminate a detected nonconformity. Which can be given through the following alternative, which is to reprocess:
- Reprocess: Action taken on a nonconforming product to make it meet the requirements.
In order to comply with said reprocessing in practice, the action considered feasible is that of repair.
- Repair: Action taken on a nonconforming product to make it acceptable for its intended use.
For example, if a bicycle does not work because the pedals are defective, changing the defective pedals automatically leaves the bicycle enabled for operation. This can generally be done on complex products.
In the case of the certificate taken as an example, it could be the case that it reaches the client's hands without the signature of the person responsible for signing it, for which it is not necessary to elaborate it again or discard it, but to put the signature that was necessary and it would already comply with the requirements.
Here it is necessary to clarify another concept presented by the standard on what is a defect which defines it thus:
- Defect: Breach of a requirement associated with an intended or specified use.
As we can see, the concept is similar to that defined for non-conformity, unlike in this case, the non-conformity presented affects the intended or specified use of the product.
In the examples presented above, we would talk about the defective pedal that does not allow the correct use of the bicycle, or the certificates that present errors in the names and surnames or in the number of the identity document.
In the same way, you can make the analysis of the products that in your company have problems and if these nonconformities affect the intended or specified use of the product.
Suggestion 5. Explain to the person who develops actions that are directly related to the quality of the product, which is the treatment of non-conforming products, as well as the different options and alternatives that the standard presents such as: Correction, Permitted deviation, Repair, Reprocess, Disposal, Defect, Concession and Reclassification; This way they will know what action to take each time a nonconformity occurs.
As we have already designed a format where non-conforming products are registered and the nature of the non-conformities found (FORM 2), we must design another to record the actions taken subsequently and which logically have to do with the treatment of these products, we do this to comply with the part of the rule that says: "Records must be kept of the nature of the non-conformities and of any subsequent action taken, including the concessions that have been obtained."
The suggested format appears below.
| INSTITUTO AUGUSTO REGISTRY OF ACTIONS FOR NON-CONFORMING
PRODUCTS PRODUCT___Certificate of approval of the course___ Format RAPNC-1 |
|
| Certificate 20 | NO CONFORMITY |
| one | The student's names and surnames are wrong |
| TREATMENT |
|
| 6 | The certificate will not be delivered on the date initially agreed with the client |
| TREATMENT |
|
| Certificate 5 | NO CONFORMITY |
| two | The identification document number is wrong |
| TREATMENT |
|
| 7 | The printing of the certificate was incomplete |
| TREATMENT |
|
(FORMAT 3)
Suggestion 6. Explain to the person who develops actions that are directly related to the quality of the product, how the actions taken after the nonconformities should be recorded and how format 3 designed for this purpose should be used.
Let's continue with what the standard requires of us.
"When a nonconforming product is corrected, it must undergo a further verification to demonstrate its compliance with the requirements."
Generally, this step must be carried out by a person other than the one who participates in the direct production of the product (a supervisor for example) and although the standard does not require it, this revision should be recorded in a format designed for this purpose, for which I suggest taking as a reference the one used for the product requirements but adding a couple of columns and thus using it as a checklist.
Let's see:
| AUGUSTO INSTITUTE VERIFICATION LIST OF COMPLIANCE WITH
PRODUCT REQUIREMENTS PRODUCT___ Course approval certificate___ VRP-1 Format CERTIFICATE CODE: ______ 5_______________________ |
|||
| CODE | REQUIREMENT | YES | NO |
| one | The student's names and surnames are correctly written | X | |
| two | The identification document number is correctly written | X | |
| 3 | The data that appears on the certificate is legible | X | |
| 4 | The certificate has the name and signature of the person responsible for the certification | X | |
| 5 | The certificate is prepared in the format assigned for this purpose | X | |
| 6 | The certificate will be delivered on the date agreed with the client | X | |
| 7 | Certificate printing is complete | X | |
| 8 | The format where the certificate is printed is in good condition | X | |
| REVISION DATE: ________________________ RESPONSIBLE SIGNATURE: _________________________________ |
(FORMAT 4)
Tip 7. Explain to the person responsible for verifying compliance with the requirements the importance of this format and how format 4 should be completed.
Let's look at another of the requirements that the standard requires regarding non-conforming products.
"When a nonconforming product is detected after delivery or when its use has begun, the organization must take appropriate actions regarding the effects, or potential effects, of the nonconformity."
The actions to be carried out in these cases must be aimed at:
1. Seek that the client does not lose confidence in our organization.
In these cases, the most advisable looking at it from the client's point of view, is that the organization replace the non-conforming product as soon as possible with a conforming product, and assume the transport costs and others if the client requests it.
In the case of defective certificates, they must be prepared again if necessary and replaced in the shortest possible time, trying to avoid further inconvenience to the client.
2. Try to make the organization be affected as little as possible, either economically or image-wise.
Find the cheapest solution possible but always putting the customer's interests first.
Finally, the regulation regarding the treatment of non-conforming products requires the following:
"The controls, responsibilities and authorities related to the treatment of the non-conforming product must be defined in a documented procedure."
As we are already clear about the actions to be carried out whenever non-conformities are presented to us in the products, we only have to establish the points in which the controls must be made and who will be responsible as well as who has the authority to release a product that is found. under certain conditions.
For this I propose the following procedure summarized in the table presented below:
| INSTITUTO AUGUSTO CONTROL OF NON-CONFORMING PRODUCTS GENERAL PROCEDURE | |||
| EXERCISE | PROCESS | RESPONSIBILITY | AUTHORITY |
| Identify nonconformities | Confront product characteristics with product requirements | People who have a direct relationship with product quality | |
| Register nonconformities | Record non-conformities in the format assigned for this purpose | People who have a direct relationship with product quality | |
| Analyze detected nonconformities | Meet to analyze the nonconformities found | People who are directly related to product quality, Area and Quality Supervisor | |
| Make decisions about the treatment of non-conforming products | Make the necessary decisions for the proper treatment of non-conforming products | People who are directly related to product quality, Area Supervisor and Quality Manager | Area Supervisor and Quality Manager |
| Implement necessary actions for treatment | Carry out the necessary actions for the treatment of non-conforming products | People who are directly related to product quality, Area Supervisor and Quality Manager | |
| Develop corrective actions | Analyze the causes of the nonconformities presented and carry out the necessary actions | Area Supervisor, Quality Manager, Human Resources Manager | |
| Develop preventive actions | Analyze the causes of potential nonconformities and take the necessary actions | Area Supervisor, Quality Manager, Human Resources Manager |
PART II
TREATMENT OF THE CAUSES OF A NON-CONFORMITY - CORRECTIVE ACTIONS AND PREVENTIVE ACTIONS
Although it is true, until now we have touched on everything related to the actions to be developed to treat non-conforming products, and attack non-conformities, now we must delve into the causes of these non-conformities and take actions in this regard to prevent situations such as these continue to occur, therefore the third step in the TREATMENT OF NON-CONFORMING PRODUCTS is:
Step 3: Take actions to prevent future non-conformities in the products we make.
The standard proposes two types of basic actions, the so-called corrective actions (carried out after the non-conformities have been filed) and the preventive actions (which are carried out before the non-conformities are presented); both have to be explained below.
CORRECTIVE ACTIONS
Let us begin by knowing what the ISO 9.001 standard requires in section 8.5.2 and what it says verbatim: Corrective action. “The organization (in this case your company) must take actions to eliminate the cause of nonconformities in order to prevent it from happening again. Corrective actions must be appropriate for the purposes of the nonconformities found. ”
A documented procedure should be established to define the requirements for:
- Review non-conformities (including customer complaints),
As we have already developed the process of identifying non-conformities and have registered it in format 3, we can use it as the basis for the analysis and review of non-conformities. This analysis must be done independently of the type of treatment given to the non-conformity, that is, the detected non-conformity can be identified and the product can be discarded, corrected or not done, and talk to the client to accept the product with nonconformity. In any case, the review and analysis process in order to have the greatest possible clarity and take the next step to determine the causes of the non-conformities.
- Determine the causes of nonconformities,
Having done the review and analysis of the detected nonconformities, we proceed to determine their possible causes where, by experience, the causes of a nonconformity may come from failures in human resources, equipment, machinery, processes, raw materials or facilities.
To facilitate the work of determining the causes of nonconformities we can design a format similar to FORMAT 3 but replacing the treatment box with that of possible causes of nonconformities and thus obtain the format that appears below:
| INSTITUTO AUGUSTO FORMAT CAUSES OF NON-CONFORMITY AND CORRECTIVE ACTIONS
PRODUCT___Certificate of course approval___ FCNC-AC Format |
|
| Certificate 20 | NO CONFORMITY |
| one | The student's names and surnames are wrong |
| CAUSES | Fingering error due to inexperience of the person responsible for the fingering |
| TAKEN ACTIONS | Ask the person doing the typing to be more careful when entering customer data. |
| RESULT ACTIONS TAKEN | The number of certificates with this type of non-conformity was reduced. |
| BENEFITS OBTAINED FROM THE SHARES | Improvement of customer satisfaction according to the last survey carried out |
| 6 | The certificate will not be delivered on the date initially agreed with the client |
| CAUSES | Failure to detect the error in a reasonable time, so that the certificate can be prepared or corrected and delivered on the agreed date |
| TAKEN ACTIONS | Carrying out the printing process of the certificates in advance so that we can make the necessary corrections and meet the delivery deadlines agreed with the client. |
| RESULT ACTIONS TAKEN | Delivery of certificates on the dates agreed with the client |
| BENEFITS OBTAINED FROM THE SHARES | Improvement of customer satisfaction according to results of the latest surveys carried out |
| Certificate 5 | NO CONFORMITY |
| two | The identification document number is wrong |
| CAUSES | Badly completed registration form |
| TAKEN ACTIONS | Request to the persons in charge of advising the completion of the registration forms to be more careful when carrying out this process |
| RESULT ACTIONS TAKEN | Decrease in errors in filling out registration forms |
| BENEFITS OBTAINED FROM THE SHARES | Decrease in errors in certification as a result of the cause initially determined (registration form poorly completed) |
| 7 | The printing of the certificate was incomplete |
| CAUSES | The printer ran out of ink at the time of printing |
| TAKEN ACTIONS | Tell the certifier to be on the lookout for printer messages about the status of the ink jar |
| RESULT ACTIONS TAKEN | Decrease in the number of non-conformities due to the cause previously established |
| BENEFITS OBTAINED FROM THE SHARES | Higher customer satisfaction regarding the certification process according to the latest surveys carried out |
(FORM 5)
- Assess the need for action to ensure that nonconformities do not recur,
Format 5 allows us to record the cause (s) of non-conformities and assess whether it is necessary to carry out actions (such as training, for example) to prevent their recurrence.
- Determine and implement the necessary actions,
If in the previous step we found it necessary to take actions in this regard, here we determine what action to develop and what strategy to use to implement said action. After implementing the necessary actions we proceed to:
- Record the results of the actions taken, and Review the corrective actions taken.
I have placed these two items together because the recording of the results of the actions taken is the basic input to review and evaluate if what was obtained as a result of the actions carried out was favorable, allowing at least the cessation of non-conformities in the elaboration of the subsequent products.
Likewise, number 8.5.3 corresponding to Preventive Action reads as follows:
“The organization must determine actions to eliminate the causes of potential nonconformities to prevent their occurrence. Preventive actions must be appropriate to the effects of potential problems.
Here what it is about is to visualize that probable nonconformities may appear in the future and, with the analysis of the possible causes, develop preventive actions to prevent them from occurring; for it:
A documented procedure should be established to define the requirements for:
- Determine potential nonconformities and their causes,
Here you must be futuristic and drawing on the experience of our workers to develop a table where the probable non-conformities of the products to be made are noted, as well as their possible causes (this is simple if we base ourselves on the table of product requirements FORMAT one).
- Evaluate the need to act to prevent the occurrence of nonconformities,
If we already have the probable nonconformities and their possible causes, we proceed to evaluate whether it is necessary to take actions or not depending on the conditions that we have at the moment in our company in terms of human resources, processes, machinery, equipment, facilities, raw materials, etc.. for the elaboration of a certain product.
- Determine and implement the necessary actions, record the results of the actions taken, and Review the preventive actions taken.
In the event that the evaluation carried out in the previous step leads us to conclude that it is necessary to carry out actions, we must determine which ones, implement their execution and record their results.
Later we review the actions carried out and the benefits obtained in order to take them as a reference and be able to apply them in similar cases that subsequently arise in our organization.
And to finish this article, I suggest you design a format similar to number 5 where for each product requirement, visualize the probable non-conformities, their possible causes, the actions carried out, and the results and benefits obtained.
"Finally, reader friend, I request that if you find this article interesting, you should give it to an entrepreneur and thus we will contribute to disseminating the culture of quality in our countries."
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