SEGURIDAD Y SALVAGUARDIAS
OTRAS ACTIVIDADES
ISO 9001:2015 doesn’t require, or even mention, preventive or predictive maintenance. It simply requires maintenance, period. The specific type of maintenance program you implement is up to you. Common sense dictates that preventive and predictive maintenance are good ideas. They lower the overall costs of maintenance and increase the availability and productivity of equipment. Should you decide to implement a more robust approach to maintenance, that’s the system against which you will be audited within the scope of your management system. Don’t let this discourage you from doing what makes sense for your business.
7.1.3 FREQUENTLY ASKED QUESTIONS
Our organization is located in a rented office. The landlord takes care of
all maintenance. What should we do about the infrastructure
requirements of ISO 9001:2015?
important than the equipment within the building. Focus on things like the computer system, telephones, and other infrastructure that are needed to produce your products within the office environment. Also make sure you have communicated your building requirements to the landlord.
7.1.4 Environment for the operation of processes
Equivalent to clause 6.4 of ISO 9001:2008.
An organization’s environment is made up of the conditions that exist in its workplace. The conditions required by ISO 9001:2015 refer to its processes, and those required to achieve conformity of product and services. Examples of environmental conditions include configuration of the work area, employee health and safety, lighting, temperature, humidity, noise, vibration, cleanliness, pest control, and contamination. The required work environment will vary greatly, depending on the product. Consider the following examples:
Candy manufacturer. Raw materials are received into the facility and immediately moved into a climate-controlled storage area. The cleanliness of the storage area is immaculate. A weekly inspection is conducted to look for any evidence of pests. Raw materials are transported into the manufacturing area by personnel wearing white gloves and smocks, and all manufacturing is tightly controlled under good manufacturing practices. All outside doors and windows are kept closed and the housekeeping is very strict; even the garbage cans are spotless. Nobody with any kind of illness is permitted inside the facility, and no jewelry is permitted. Once manufacturing is complete, the finished product is stored in an area that is maintained at 40° F, +/- 4°, and the gage used to monitor the temperature is calibrated. A weekly audit is conducted to evaluate the condition of finished product in inventory.
Insurance company. People are stationed at desks and perform work on computers and telephones. The office temperature is maintained at typical office conditions, which is usually a compromise between the women who like the office warmer and the men who like it cooler. Dress codes are enforced so personnel are not distracted in their work and to maintain a professional environment in the event customers visit. Personnel are not allowed to play music from their radios or computers, as the sound disturbs people in their work, even when played at low volume. Hot food items are restricted to the break rooms, as some employees were offended by the smells of certain foods that were consumed at desks. Personal photographs and decorations are
permitted in cubicles, but nothing that could constitute a threatening work environment is allowed. Everything about the office is maintained in a pleasant yet bland manner because this is the environment that was found to result in the highest productivity, lowest service defects, and fewest personnel problems. Paper mill. The inside of the plant is very damp, and a half-inch of water is on most of the floors. Additionally, the nature of the production process is very hot in some areas, and the ambient temperature in the summer can reach more than 110° F. During winter months, temperatures in the warehouses are just a few degrees above freezing. For many years, the harsh environmental conditions were simply accepted as a given. The conditions didn’t negatively affect the product, so management felt no need to change anything. Recently, it became clear that employees were becoming ill at a higher than normal rate, however. The increased illnesses affected the mill’s attendance rate, which in turn affected its ability to produce paper on schedule. Work conditions are being improved now that the link between the environment and product conformity was recognized. In all these cases, the environment is focused on what is needed for the product the organization produces and the processes that make it happen. Sometimes organizations discover connections between the environment and product conformity that they didn’t know existed, as in the paper mill example. ISO 9001:2015 simply says that you will determine the environmental conditions that you require. Whatever you require is what you will be expected to provide and maintain. Here are some typical controls related to specific work environment variables: Temperature and humidity. Gages for monitoring, records of conditions,
records of gage calibration, investigation of affected product when conditions fail to meet environmental requirements
Safety hazards. Identification of hazards, prioritization of risks, procedures for job safety, monitoring of compliance, records of monitoring, corrective action on accidents and near misses, regular meetings to discuss safety issues
Lighting, noise, vibration. Specifications for characteristics, procedures for maintaining specifications, ongoing measurement of characteristics, records of measurement, calibration of gages, records of calibration
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Housekeeping. Procedures for housekeeping, defined responsibilities, training of personnel, periodic audits of housekeeping, corrective action on nonconformities, signage to remind personnel of guidelinesPersonal hygiene and behavior. Documented policies for personnel, recurring training, monitoring by supervisors, and counseling for employees
ISO 9001:2015 doesn’t require that you maintain or retain documented information (procedures or records) related to environment, though it usually makes sense to have them in place. In cases where the organization establishes requirements for environment, the only way to verify that the environmental conditions were met would be through records. Documentation would also be required to consistently communicate environmental requirements and controls.
The notes section at the end of subclause 7.1.4 expand what people might consider to be the environment, including social, psychological, and physical factors. Social, in particular, seems to stray far beyond what most people would consider to be the purview of the QMS. These are provided only as examples of what the organization might consider, not requirements that must be specifically addressed. The bottom line is that it’s always up to the organization to determine the environmental characteristics that affect its processes, products, and services.
7.1.4 FREQUENTLY ASKED QUESTIONS
We have a gage that monitors the temperature of our warehouse, which
must be maintained at 50° F +/- 10°. Does the gage have to be
calibrated?
Yes. Because you’ve committed to a particular work environment, having accurate readings of that environment is necessary.The note at the bottom of this section includes a lot of unusual
environmental factors: social, psychological, physical. We don’t have to
consider all these, do we?
No, these are simply given as examples. It’s very unlikely that many companies will take environment to those extremes, because the conditions needed for running processes and products don’t require consideration.
7.1.5 Monitoring and measuring resources
7.1.5.1 General
Equivalent to clause 7.6 in ISO 9001:2008, but with less emphasis on calibration. The focus of this section is determining the “suitability” and “fitness for purpose” of measuring instruments. This is a departure from previous revisions of ISO 9001, which focused almost entirely on calibration. Calibration may still be applied, but the organization now has much more discretion in how it determines suitability and fitness for purpose. The decision hinges on the need for measurement traceability. If traceability is required, then calibration or verification is triggered.
Let’s back up and define a couple of key terms: suitability and fitness for purpose. Suitability means selecting the correct monitoring or measuring resource for the job at hand. The resource must be capable of making the measurements required and have enough resolution to detect the increments sought. For example, a floor scale used for weighing pallets of material is not suitable for detecting grams. The instrument simply wasn’t designed to read in increments that small. Suitability comes into play when a monitoring or measuring resource is selected, and again as the organization’s processes and products are modified. A particular resource might be suitable for some jobs but not others.
Fitness for purpose requires maintaining the monitoring or measuring resource in a way that preserves its ability to make measurements. This can encompass a wide variety of activities, including: Calibration Verification Preventive maintenance Breakdown maintenance and repair Visual inspection of the resource for damage or deterioration Automatic replacement after a defined timeframe Repeatability and reproducibility studies Statistical analysis of measurement variation
Calibration is the most typical process for ensuring fitness for purpose, but organizations have other choices. It’s the organization’s responsibility to analyze its monitoring and measuring resources, understand how they’re used, and determine what
process will best indicate fitness for purpose. Here are some examples:
Visual inspection. The Western Novelty Company makes marketing displays for retail stores. The displays are made of cardboard and plastic, and have dimensional tolerances of +/- 0.25˝. At this tolerance, the quality manager has determined that tape measures are suitable for the measurements to be made. To ensure fitness for purpose, the tape measures are visually inspected for damage by the quality technician twice a year. The quality technician ensures that the numbers and markers are clear, the tab on the end is intact, and there are no kinks, bends, or cuts in the tape. A record of the each tape measure’s fitness for purpose is retained in the lab.
Automatic replacement. R.M. Zimburger Inc. mills aluminum trihydrate powder for a variety of industrial applications. Each batch is tested in the lab using metal sieves with varying mesh sizes to test the particle size of the powder. The metal sieves are replaced every December to ensure they’re fit for use. The manufacturer of sieves has warrantied that the sieves should remain accurate for at least two years unless they’re dropped or punctured.
Verification. Grandma’s Catering provides breakfasts and lunches for local businesses. They deliver pre-prepared food in stainless steel serving trays, which are warmed by gel fuel cans. Mercury thermometers are used to ensure that the temperature of food is maintained at a minimum of 140° F. Twice a year the thermometers are verified by checking them in boiling water. As long as the thermometers read 212° F +/- 5° F they are considered verified. The owner of Grandma’s Catering states that because they generally use the set point of 145° F for food (5° F above the temperature danger zone), the 5° F tolerance ensures that they are fit for use. Thermometers that fall outside the verification tolerance are replaced. The owner of Grandma’s Catering maintains records of the thermometer verification.
ISO 9001:2015 requires that you retain documented information (i.e., records) on fitness for purpose. If you perform calibration, then naturally this would indicate fitness for purpose. As we’ve discussed, a handful of other activities might also indicate fitness for purpose. Whatever evidence proves fitness for purpose should be retained as a record. Also be prepared to explain why your method makes sense.