ISO 9001 – The Control of Non-Conforming Outputs (Product and/or Services)

Non-conforming Products or non-conforming service provision! Every business deals with this on a daily basis.

There is no business out there that runs and operates 100% perfectly with no complaints from customers, no matter how little or how big!

There is no production or manufacturing facility that does not generate scrap or reworks, once again, no matter how little or how many

My father worked for many years as a Boiler-maker in various quite large production/manufacturing facilities, and he told me one of his Managers once told him that there is an ironic culture within the manufacturing/production industry for some odd reason, and saying that states the following, and that is “There is NEVER enough time to do something right the first time, but ALWAYS enough time to do something over” (or to rework something). This made me think and it was actually 100% correct. In all my experience as a consultant and involvement in various Production/Manufacturing companies, there has always been some sort of explanation or excuse why something could not be done right the first time, and the same applied to customer complaints (it’s always the customer that is difficult or “making a big thing about nothing”).

I normally refer to the motto of a very reputable and well-known electronic device manufacturer, and it states “The Strive for Zero Defect”. Although this is very admirable and a very good vision to have, it will always only remain an attempt or aspiration, but it will never be achieved, as zero defects (or let’s call them non-conforming outputs) will always be part of any business, but it depends on how a business controls and manage non-conforming outputs to reduce its occurrences or re-occurrences.

Therefore, to control and manage non-conforming outputs effectively, the following needs to be addressed, and it doesn’t matter whether it is with regards to a non-conforming product/s or non-conforming service-provision:

• Identification
• Segregation
• Decision-making and Corrective Action

First and foremost, one needs to put controls in place to identify non-conforming product/s and/or non-conforming service provisions. With regards to non-conforming service provision, one can control this by having a register in place to record non-conforming service-provision activities that directly impacted or would have impacted Customer Satisfaction, i.e. affecting the customer/s directly. The same applies to non-conforming products, however, more controls are needed apart from a register in this regard, i.e. these products need to be tagged, binned, barricaded, etc. with the necessary identification on them in order for everybody to see and acknowledge that this product / s are on-hold and/or non-conforming. Best practices normally include colour-coded tags, e.g. Red = Scrap, Yellow = Rework, White = Approved under Concession, Green = Acceptable after Rework/Approval under Concession, etc.

The second most important action with regards to product/s specifically is segregation. Once non-conforming product/s is identified, it needs to be moved to a designated Quarantine Area, preferably lockable. This is to prevent the unintended use of these products and prevent it from being incorporated into other product/s, as well as being delivered/collected by customers. The segregation period of product/s quarantined depends upon the decisions made regarding the immediate corrective actions to be taken, i.e. scrap, rework, accept under concession, etc. Further to this, although immediate corrective actions are taken, “preventative” corrective action still needs to take place to ensure the same non-conformities do not occur or reoccur again, i.e. controls, procedures, work instructions, standard operating procedures, need to be reviewed and revised, as necessary, or additionally added to a process or the Quality Management System.

Remember, the main purpose and benefit/s of ISO 9001 are to carry out activities and provide product/s and service-provision consistently, under controlled conditions, to ensure nothing can go wrong that could affect customer satisfaction, including meeting customers, including applicable statutory/regulatory requirements.

Thirdly, decision making, and corrective action/s include various actions, as already mentioned above. It entails the following:

• Acceptance under Concession – Although this is not recommended, because it actually represents the impression of overruling customer, statutory/regulatory, and/or your own requirements, one could seek to obtain acceptance under concession, i.e. top management should decide whether the product/s is acceptable for release, but preferably permission should ultimately be obtained from the customer/s for accepting the non-conforming product/s. They should normally be recorded and maintained for reference purposes, especially where warranties and/or guarantees are provided with this product / s.
• Rework – If acceptance under concession is not an option, one would secondly want to see whether the product/s can be repaired/reworked, i.e. salvaged to still make use of it without losing material costs (although labor costs will be more).
• Scrap – If non-conforming product/s cannot be reworked (repaired) or acceptance under concession is not an option, this product /s are to be scrapped and a loss of material costs (and labor-costs) would occur.

But by controlling and managing non-conforming outputs to reduce its occurrences or re-occurrences, as mentioned above, one must record whatever actions were taken and register all non-conformities. This information should be analyzed and evaluated after certain periods, to be determined by the business, in order to identify any trends over such period. These trends might highlight continuous problems with old machinery, incompetent people, poor quality materials, incorrect specifications/drawings, i.e. measurements, which could also include unreliable or inadequate monitoring and measuring equipment (resources) and the use or lack of use thereof.

This is normally always linked to the 5 M’s:

• MAN – People/Training
• MACHINE – Equipment/Machinery
• MATERIAL – Raw materials
• METHOD – Processes/Procedures/Work Instructions/Standard Operating Procedures (S.O.P’s)
• MEASUREMENT – Specifications/Drawings/Acceptance Criteria/Monitoring and Measurement Equipment (Resources)

These trends should be addressed by taking Corrective Actions in order to eliminate or reduce thei occurrence or reoccurrence through the use of formal Non-conformities and Corrective Actions Procedure where the root cause of the non-conformities should be determined and addressed

By doing all the above-mentioned, a business won’t eliminate all its non-conforming product/s or non-conforming service-provision, but will definitely reduce it, resulting in saving costs and showing more profit.

Call 9001 Consult! We are ready to assist you in this regard by putting the correct processes, procedures, work instructions, and standard operating procedures (S.O.P’s) in place, as necessary, and start saving money today!!