Control of production at I. Technical Services

Managing operations can be as simple as ringing a bell. That’s the philosophy that I. Technical Services has taken in Alpharetta, Georgia. I. Technical Services (www.itechserv.com) performs electronic manufacturing services, including PCB assembly, system assembly, test engineering, repair, and logistics. They compete against low-cost companies in Asia and elsewhere, so they have to be as efficient and lean as possible. One of their most efficient processes for managing production is their “bell meeting.” At 9 AM every morning, their production supervisor rings a ship’s bell mounted on the wall. All the managers and supervisors assemble under the bell for a stand-up meeting that lasts about 15 minutes. They discuss what is running that day, what needs to be shipped, and any obstacles or concerns. Important notes are recorded on a white dry-erase board right below the bell. “Everybody leaves that meeting knowing exactly what needs to happen,” Quality Manager, Hector Rivera, stated. “It’s the best investment of 15 minutes you can imagine.” Throughout the day, employees refer to the production notes on the white board, keeping themselves focused on what was agreed to. They ring the bell again at 3 PM every day, and the key players once more gather around the bell. The focus of this later meeting is to get everybody caught up on the current status of production. Where are we right now? What is left to be done? Will we meet all of our commitments today? Resources are re-arranged, as needed, and last minute roadblocks are removed. The General Manager, Lauren Thompson, summarized the process by saying, “When we come together under the bell, we’re not managers of different departments. We’re a single team working to wow the customer. It reminds us why we’re there in the first place.” I. Technical Services has conducted their bell meeting twice a day for years. It’s a very simple, yet powerful process for controlling production. 

High Impact Auditing

Internal auditing, the process by which an organization examines its ability to meet internal and external requirements, can be one of the most effective tools for triggering continual improvement. It can also be an expensive waste of time and a source of endless frustration and conflict. Which it becomes for you depends on how your organization plans and manages its audit system.

Auditing is not only a balancing act--identifying positive and negative aspects of a company’s performance--but also a planned activity, with auditors and auditees agreeing on the audit’s time, place and scope. Surprise audits are neither necessary nor desired. Internal audits generally use an organization’s existing personnel for the task, although outsiders are occasionally called in.

Internal audits offer huge benefits, both to the organization’s top management and the auditors. Top managers can:
* Discover what’s really going on within the organization, which allows for more objective decision making
* Learn of potential problems before they explode into issues that pose significant risk to the organization
* Ascertain where failures occur, enabling the containment of these problems and initiation of corrective action
* Identify where resources should be directed
* Determine how effective their training efforts are
* Learn which processes and personnel are particularly effective, which can trigger recognition

For their part, internal auditors:
* Gain exposure to other parts of the organization, which broadens their experience
* Are exposed to best practices they can implement in their own departments
* Learn how they contribute to the organization’s success, which increases motivation and employee retention
* Expand the organization’s competency and knowledge base through their experience

An effective internal audit system must work in concert with other systems, especially corrective and preventive action. An internal audit takes a snapshot of the organization, identifying nonconformities, opportunities for improvement and positive practices. Auditors don’t propose specific actions, fixes, solutions or recommendations. They simply identify where failures and successes occur. By their nature, audits typically identify more failures than successes, and these failures are called audit nonconformities.

Requirements vs. opinions

To identify a nonconformity, a requirement is needed. You might have a concern, remark or opportunity, but it’s not a nonconformity unless it’s clearly tied to a requirement, a fact that’s often overlooked.

Any activity, process or outcome that doesn’t meet requirements is a nonconformity. A number of sources, such as ISO 9001, inspection checklists, purchase orders and product specifications, could introduce specific requirements the organization must implement. The auditor’s opinions, notions, philosophies and personal experiences, however, don’t constitute requirements. When people audit with an eye toward driving continual improvement, requirements are sometimes “invented,” albeit usually with good intentions. One of the best techniques for ensuring audit nonconformities are written correctly is insisting that they’re structured in two parts:

Requirement--Exactly what the organization has committed itself to do

Finding--Exactly what the organization has or hasn’t done that contradicts the requirement

Objective evidence

Objective evidence is a factual recounting of what was seen, heard or experienced during the audit. Gathering this evidence takes the most time and effort.
It is recorded in the “finding” portion of the requirement and describes exactly how the organization failed to fulfill the requirement.
Objective evidence meets a number of criteria. Among other things, it’s:
* Not subject to bias or prejudice. Auditors can’t allow their personal feelings to influence their interpretation of the evidence.
* Traceable. As many identifiers as possible should be recorded (e.g., date, time, function, department, machine, customer, order number and product code).
* Expressed as simply as possible. Sometimes auditors will provide a paragraph or more of detail, thinking that more data will provide more convincing evidence. However, the objective evidence is best streamlined and to the point.

Objective evidence is stated in such a way that the first half of the nonconformity directly contradicts the requirement. Enough detail is provided to facilitate traceability--but not so much that it overwhelms. Auditees expect concise and clearly written findings.

Consider the following correct audit write-up:

* Requirement: The general manager stated that all employees are expected to understand the facility’s key measures and how to contribute to them. (Note that the requirement comes from the general manager’s statements, which function as requirements when he’s talking about something under his control.)
* Finding: Three out of five employees sampled randomly in the shipping department didn’t understand the facility’s key measures or how to contribute to them. (Note that the finding’s language mirrors that of the requirement, stating exactly how the organization failed to meet its commitment. The sample size is defined, and the location is also identified. Employee names, however, are appropriately omitted.)

Now look at this incorrect write-up:
* Requirement: All employees should understand key measures. (Note that it isn’t clear whether this is an opinion or a requirement. Where did this “should” come from?)
* Finding: Employees were ignorant of the organization’s objectives and strategic direction, and they were obviously unprepared to assist in continual improvement. (Note that here, the finding’s tone is subjective and accusatory. Sample size and other identifiers are omitted, which provides insufficient traceability.)
It generally takes a number of audits before an inexperienced auditor can confidently draw conclusions from objective evidence and write nonconformities clearly and concisely. Practicing the audit process with an experienced auditor is time well spent.

The system, not the people

One of the best ways to understand the system and its effectiveness is through people: how they receive and interpret information, carry out instructions, produce goods and deliver services according to requirements, and satisfy customers. Nevertheless, an audit must always focus on the system itself.

Some auditees might suspect that an audit constitutes a personal attack on their jobs, and auditors must be prepared for that reaction. They should calmly explain that the audit process is all about the system, put the auditees at ease and depersonalize the process as much as possible. If people are uneasy about the audit process, they won’t provide objective evidence, and the audit, in turn, won’t trigger continual improvement.

Does this mean people never screw up? Of course not. But when failures are identified during an audit, they’re system failures. Very few nonconformities occur due to willful employee misconduct. If someone makes a mistake or fails to carry out a job step, it’s usually because the system is flawed and error-prone. Fix the system, and people will have less opportunity to screw up.

Auditing strategic processes

Not all organizational processes have the same strategic significance. An internal audit system that’s oriented toward continual improvement will focus on strategic issues. Most management system standards such as ISO 9001 require that organizations schedule audits based on status, importance and prior audit results. This means organizational processes with more strategic importance will be audited more often.
The following audit questions reflect on processes that typically have high strategic importance:
* Customer satisfaction. What methods does the organization use to capture customer perceptions? How are data on customer perceptions reported and analyzed? Has overall customer satisfaction improved?
* Corrective and preventive action. Is there proof that root causes or potential root causes are being identified? Are actions taken to eliminate root causes or potential root causes? Are data on corrective and preventive actions reported and analyzed?
* Leadership. Has the organization determined its mission and strategy? Are organizational performance and direction communicated throughout the organization? Has top management led the review and action on key measures and other important information that indicates organizational success?
* Internal auditing. Do auditing schedules clearly reflect the strategic importance of processes and the results of previous audits? Does the organization’s management take corrective action on nonconformities raised by audits? Are the corrective actions effective, based on the evidence?
* Design and development. Are design inputs and outputs recorded and approved? Is progress against the design plan periodically reviewed? Is the design process’s output validated under conditions of application or use?
* Transformation. How is work planned and scheduled? What information guides work performance in general? How do employees receive feedback on their work? Do employees understand how their efforts affect key measures?
These audit questions are examples and might not be applicable to all organizations. Other processes could have strategic significance, depending on the organization’s nature and competitive environment.

Training auditors

Many audits produce poor results because auditors haven’t received proper instruction or been given opportunities to practice what they’ve learned. The organization must invest the necessary time and effort in making its auditors competent and confident before they’re assigned an audit.

Auditors must be familiar with:
* Practical interpretations of the standard adopted by the organization
* The audit’s purpose and how it drives continual improvement (i.e., by providing a balanced picture of the organization and triggering corrective and/or preventive actions)
* Phases of the audit and various activities within each phase
* Sources of audit requirements (e.g., the standard, procedures or sales orders)
* Methods of gathering objective evidence and drawing valid conclusions
* Diplomacy skills and effective interpersonal communication
* Audit role-playing under controlled conditions
* Writing nonconformities in the prescribed format
* Actual auditing with an experienced auditor

Auditor training doesn’t necessarily need to be formal or even classroom-based. The style and format of training will differ significantly from one organization to the next. However, auditors must have a conceptual understanding of the process and a practical grasp of techniques, both backed up by sufficient practice. When auditors truly understand their roles and responsibilities, the process should result in strategic continual improvement.

A successful audit almost always results when an individual takes personal ownership of the process. He or she must be able to carry out the following five complex and linked activities, which create strategic continual improvement.

Audit scheduling

An audit schedule defines the auditing that will take place during an extended period of time, usually six months or a year. The purpose of the schedule is to communicate when and where the audit team’s services will be needed, when the organization can expect to be audited, and what requirements will be included in the audit.

Audits scheduled far in advance always produce better results. Note, too, that the processes considered more strategically important to the organization are scheduled for audits more often. Processes and functions that have performed poorly in previous audits are also scheduled for frequent audits. Regardless of other considerations, all processes, functions and departments within the scope of the management system must be audited at least once a year.

The schedule can be keyed to organizational processes, departments, functions, facilities, an ISO standard element or something else. However, it must clearly communicate which audits are coming up and when. Audit schedules should provide enough detail to guide the overall process and help with the next step, audit planning.

Audit planning

An audit plan is focused, detailing a single audit’s scope, objectives and agenda. The plan provides a chronology of the audit from start to finish: which processes will be audited, exactly when they’ll be audited, who will do it and which requirements will be audited in each segment. Even details such as meetings, breaks and lunches are shown on the plan in order to clear up any timing conflicts between auditees and auditors and keep the audit on track.

Typically, the audit plan is distributed several days prior to the audit. Auditees often request alterations to the plan based on logical concerns and existing commitments. By all means, modify the plan to accommodate them. The one variable that usually never changes, however, is the audit’s scope.

Audit supervision

The audit’s on-site phase consists primarily of gathering evidence. The lead auditor takes part in this and also manages the overall process. These duties typically include:
* Leading the opening meeting
* Managing and communicating changes to the audit plan
* Ensuring that the audit stays on track
* Insisting that auditors remain objective, consistently evaluating all evidence
* Encouraging auditors to write up their findings during the audit to avoid a time crunch directly before the closing meeting
* Reviewing all nonconformities to ensure that they’re logical, valid and clear
* Providing performance feedback to audit team members so individuals can target areas for their personal improvement
* Resolving all conflicts constructively
* Apprising the auditee of the audit’s progress
* Leading the closing meeting
* Ensuring that the entire audit is conducted professionally and positively

If these duties sound difficult, it’s because they are. Many organizations have ineffective audit processes because the so-called lead auditor doesn’t understand his or her responsibilities. An accredited lead auditor course is a very good investment for individuals who function as lead auditors for their organizations.

Audit reporting

The first formal reporting that takes place during an audit is the closing meeting. The lead auditor presents a verbal summary of the audit, including positives and negatives. Depending on the audit’s size and duration, the closing meeting might last from 15 minutes to more than an hour. The meeting allows for back-and-forth dialogue between auditors and auditees. During the closing meeting, auditee management is presented with the written audit observations and/or corrective action requests, and these form the basis for discussion of the audit results.

Subsequent to the closing meeting (and occasionally during the closing meeting), an audit report is presented to the auditee management. This summarizes the audit’s overall themes and trends. Usually it’s written by the lead auditor, based on evidence gathered by the entire audit team. The report doesn’t belabor every audit observation because these should have already been addressed during the closing meeting. Audit reports should be as concise and streamlined as possible. Graphics such as matrices and Pareto diagrams are helpful.

Verification and closure

The auditee management is usually asked to respond to audit nonconformities by an agreed date. The response should include investigation into the root cause, proposed corrective action and a date when the action should be completed.

The lead auditor reviews the responses to determine whether the investigation and proposed corrective actions are adequate. This is the first stage of verification.
One of the most important jobs the lead auditor and auditing team can perform is a careful scrutiny of auditee responses. Accepting weak investigations and/or corrective actions does nobody any favors and certainly doesn’t trigger continual improvement. If a response doesn’t identify a plausible root cause or propose a corrective action related to it, the lead auditor must diplomatically reject the response and explain to the auditee why it’s adequate. The auditee is the audit process’s customer and should be treated with the same respect that any other customer would receive.

The second stage of verification occurs when the auditee notifies the lead auditor that corrective action has been implemented. At this stage, the lead auditor or a team member will verify that the corrective action has been fully implemented and the root cause of the original nonconformity has been eliminated.
Verification is sometimes performed by reviewing records or documents submitted by the auditee; alternatively, an on-site visit is made to review evidence in person. The nonconformity’s nature and significance will determine whether on-site verification is necessary.

Once all audit nonconformities have been addressed with effective corrective action, the audit is considered closed. However, this doesn’t mean it’s forgotten. A high-level discussion of audit results is an important input to the business review process, and audit trends influence resource allocation and strategic decision making.

ISO 9001 in Plain English

New Book Translates International Quality Standards into Plain English

Buy it HERE

Although international quality standards were written to apply to a wide variety of organizations worldwide, many companies have a difficult time interpreting them. To address this problem, Craig Cochran, the north Atlanta region manager for Georgia Tech’s Enterprise Innovation Institute, has written a new book, ISO 9001: In Plain English (Paton Press, 2008).

“To make the international standards applicable to everybody, they are not particularly applicable to anybody,” he noted. “The words and phrases used are not typically those that workers are accustomed to using. If you don’t have extensive experience interpreting international standards, putting them to use in your own company can be very difficult.”

ISO 9001 is an international quality management system standard that presents fundamental management and quality assurance practices applicable to any organization. The generic requirements of the standard represent an excellent foundation of planning, control and improvement for just about any enterprise. Companies that are ISO 9001 certified have a demonstrated baseline of managerial discipline and control, and, according to Cochran, they also have higher rates of customer satisfaction.

The newly-released book is targeted toward anybody who has to implement or audit within an ISO 9001 management system. After a 20-year career in quality, Cochran wrote the book to share some of his experiences in implementing quality systems.

“People interpret ISO 9001 in diverse ways, including those that are often just plain wrong. Because I’ve been working with the ISO 9001 standard since 1988, I thought people might benefit from my experiences,” he said. “I have assisted in implementing ISO 9001 in nearly one thousand organizations, ranging in size from two to 20,000 people, and in every imaginable industry.”

Cochran’s book includes sections on process approach, relationship with ISO 9004 (a standard on continual improvement), compatibility with other management systems, application, vocabulary and definitions, general requirements, management responsibility, resource management, product realization, and measurement, analysis and improvement. For additional information about this book or Georgia Tech’s quality services, please contact Craig Cochran (678-699-1690); E-mail: (craig.cochran AT innovate.gatech.edu).

About the Enterprise Innovation Institute:
The Georgia Tech Enterprise Innovation Institute helps companies, entrepreneurs, economic developers and communities improve their competitiveness through the application of science, technology and innovation. It is one of the most comprehensive university-based programs of business and industry assistance, technology commercialization and economic development in the nation.
http://innovate.gatech.edu

Press release writer: Nancy Fullbright

Buy the book HERE

ISO 9001:2008 – How it will Impact your Auditing

By Craig Cochran
(Originally published in The Auditor, Jan-Feb 2008)

Auditing is all about comparing evidence to requirements. That’s why changing requirements always grab the attention of auditors. As most of you know, ISO 9001 is undergoing a revision that is scheduled to be published in 2008. The new standard, ISO 9001:2008, includes mainly editorial amendments: re-arranged words but few significant changes. There are a few things that auditors should take note of, though. Let’s take a look at the Draft International Standard of ISO 9001:2008 and discuss how it might impact your auditing.

Statutory requirements

The word statutory will be inserted in a couple of places within the introductory part of the standard. This is primarily to make the language consistent with section 7.2.1—determination of requirements related to the product—which has always required that the organization determine statutory and regulatory requirements for its products. Even though the concept is not new, the requirement reminds all auditors that they need to understand the legal requirements of the products they’re auditing. Statutory and regulatory requirements are often taken for granted by auditors, with the assumption that the organization knows what applies to its products. This is not always the case. During the planning phase, auditors must research the statutory and regulatory requirements on the product produced by the organization, and make sure they able to effectively evaluate this.

Technically, there is a difference between statutory and regulatory requirements. It’s a very fine difference, though. We’ll cover it briefly for the sake of completeness. Statutes are laws. They say what you can and can’t do in broad terms. Regulations are usually specific guidelines published and enforced by regulatory bodies. The bottom line is that statutes and regulations are both enforced by authorities that can make your life difficult. Understand what statutes and regulations apply to your products, and make sure you’re able to meet them. Satisfaction of this clause is typically achieved in a two part manner:

• Developing a process for understanding and staying up-to-date with statutes and regulations
• Compiling an index or listing of statutes and regulations applicable to your products
  

These processes are not specifically required by ISO 9001, but they would represent an effective way of meeting the requirement.

It’s worth noting that statutes and regulations can come from the country in which you are based, and they can originate from countries in which you’re selling your products. Multinational organizations have to consider statutory and regulatory requirements everywhere they operate in the world. Understanding and staying current with statutes and regulations can become somebody’s full time job for companies that operate around the globe.

This clause is also very significant for companies that produce highly-regulated products. Examples of highly regulated products include:
* Drugs and pharmaceuticals
* Medical devices
* Food
* Aircrafts and aircraft parts
* Explosives and firearms

Management representative

ISO 9001:2008 will clarify who can act as the management representative. That role must be held by a member of the organization’s management. This makes 2 things clear:
The management representative is an employee of the organization (not a consultant)
The management representative is someone with the responsibility and authority to make decisions, assign resources, and get things done.

In the past, the decision of who was assigned as management representative was usually unchallenged by auditors. This will need to receive some new scrutiny by auditors to ensure that the assignment meets the full intent of ISO 9001:2008. Besides being a member of the organization’s management, there are 3 responsibilities that must be carried out by the management representative and which auditors must verify:

1. The management representative will ensure that the processes of the quality management system are established, implemented, and maintained. This is the project management aspect of being a management representative. Establishing, implementing, and maintaining a QMS requires that the management representative must coordinate many different efforts and continually sell the benefits of the system. It bears repeating that the management representative does not own the system, though. Everybody owns the management system, led by top management.

2. The management representative will report to top management on the effectiveness of the management system. This happens during management review, possibly the most important process of the entire standard. The management rep does not need to personally collect and present the data on effectiveness, but they make sure it happens. The most effective management reviews involve a wide range of organizational managers and influencers, with the management representative coordinating their input.

3. This basically means that the management representative must help promote a customer focus throughout the organization. There is nothing more important to the organization’s success than the customer, and the management representative must continually remind everyone of this fact. Promotion of awareness can be accomplished in many ways, and here are a few simple ways that come to mind:
* Posting data on customer feedback trends
* Publishing product specifications
* Holding meetings that address customer issues
* Serving as a liaison between the organization and the customer
* Distributing memos and emails that clarify customer requirements

Competence

The competence and training requirements of ISO 9001 have long been some of the most confusing. The reason is that the standard specifies some broad requirements and gives the organization total discretion for how they will be applied. This discretion has been tightened a bit through the requirement that the organization “ensure the necessary competence has been achieved.” This replaces the previous requirements for evaluating the effectiveness of training.

Ensuring that competence has been achieved can take place in a number of manners, but the most obvious is a demonstration of the newly developed skills or abilities. This works especially well for competency building aimed at skills and training. “Okay, we’ve talked about the task, and we’ve demonstrated how it should be performed. Now you give it a try.” If the trainee is able to effectively perform the task over the period of observation, then they could be reasonably considered competent. Keep in mind that the period of observation could be an hour, day, week, or month. It all depends on the complexity of the skill being demonstrated. Most “on-the-job training” programs focus on this kind of evaluation. The trainee starts out as an apprentice and then gradually begins performing many of the tasks themselves. The training culminates in the trainee being able to demonstrate the full range of skills involved with the job.

The inspection of an employee's work or product can verify that competence has been achieved. For employees who produce a tangible good or deliver a service, this is often a reasonable indicator of whether training has had the desired effect. Many organizations already have existing systems for inspecting their products, and these systems can be channeled into the training program. But this will only work if the product's inspection is traceable back to individual employees.

Tests and examinations can be used to ensure that competence has been achieved, especially when the competence is related to knowledge and facts. Be aware that many individuals simply don't perform well on formal tests or examinations, regardless of the quality of the instruction and training materials, so this may not be an ideal gauge of effectiveness. Another drawback is that tests are heavy on administration, requiring someone to spend a great deal of time creating the tests, making sure that all learning objectives are addressed, creating answer keys, creating a grading scale, taking time to grade the tests, dealing with test anxiety and disappointment, and so on. Tests and examinations do have the advantage of resulting in a numerical score, which is easy to quantify and track over time.

Finally, some organizations use performance reviews to draw judgments on whether employees have achieved competency. Most organizations already use performance reviews of some sort. As long as a logical connection can be made between the training and the job performance, the system will work. One caution, however: Make sure to separate the record of performance review from the record of training effectiveness evaluation, as every organization seeking to keep or gain ISO 9001 registration will be required to provide evidence of the evaluation to its third-party auditor. Showing performance review records to outside parties will create ethical (as well as legal) problems, so you're far better off maintaining separate files.

Auditors will need to probe the issue of competence deeper than they have in the past. What was once accepted as meeting requirements may not meet the requirements of ISO 9001:2008.

Work environment

ISO 9001:2000 will add a note in order to clarify the scope of work environment. Notes are not auditable, of course, but they provide insights on how to interpret the requirements that are auditable. The note states that work environment includes physical, environmental, and other factors needed to produce the products in question. Consider the following examples:

Candy manufacturer: Raw materials are received into the facility and are immediately moved into a climate controlled storage area. The cleanliness of the storage area is immaculate, far different than most other warehouses. A weekly inspection is conducted to look for any evidence of pests. The raw materials are transported into manufacturing 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 clean and spotless. Nobody with any kind of illness is permitted inside the facility, and no jewelry is permitted to be worn. Once manufacturing is complete, the finished product is stored in an area that is maintained at 40 degrees F, plus or minus 4 degrees, and the gauge used to monitor the temperature is calibrated. A weekly audit is conduced 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. Personnel photographs are decorations are permitted in cubicles, but nothing that could constitute a threatening work environment are allowed. Everything about the office is maintained is 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 over 110 degrees. 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 impacted 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 work environment is focused on what is needed for the product in question. Sometimes organizations discover connections between the work environment and product conformity that they didn’t know existed, as in the paper mill example. ISO 9001 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: Gauges for monitoring, records of conditions, records of gauge 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 characteristic, procedures for maintaining specifications, ongoing measurement of characteristic, records of measurement, calibration of gauges, records of calibration

* Housekeeping: Procedures for housekeeping, defined responsibilities, training of personnel, periodic audits of housekeeping, corrective action on nonconformities, signage to remind personnel of guidelines

* Personal hygiene & behavior: Documented policies for personnel, recurring training, monitoring by supervision, counseling for employees

ISO 9001 does not require documented procedures or records related to work environment, though it often makes sense to have such things. In cases where the organization establishes requirements for work environment, then the only way to verify that the environmental conditions were met would be through records. Documentation would also be required to consistently communicate the work environment requirements and controls.