Posted by & filed under ISO9001:2015.

 I have seen comments recently via LinkedIn where some contributors to the quality groups seem to be under the impression that no, or little, documentation is required to meet the ISO9001:2015 standard. No such luck; there are specific requirements under “Documented Information” and other clauses of the draft revision.

“Documented information”  replaces “Documentation Requirements”. It is defined as “information that is controlled and maintained by an organisation and the medium on which it is contained.” It can be in any format and media and from any source.  This will certainly include electronic media and the authorised signatories.

Although it appears that organisations will be able to choose when documentation is or is not required, records for quality-critical processes will have to be produced and maintained in current revision status, as before.

Question:  where in your organisation are documents required (records) or when can judgement of experienced and qualified staff be accepted in lieu of documents?

Documents can include those required to describe and manage the management system
and related processes. This means that all quality-critical processes, policies and procedures must be examined for evidence of results achieved.

A written and published quality policy is also required; (register on this website to see example).

The requirements are clear in that the quality policy shall

  • be available as documented information

  • be communicated within the organization

  • be available to interested parties, as appropriate.

  • be reviewed for continuing suitability

 

Ask the question:

If an assessor was examining your organization, would he or she be able to find the evidence (validation and verification) that the requirements of the standard and the quality system objectives had been met?

I think we will be relying on documented evidence as much as ever. I would be happy to hear from anyone who thinks otherwise.

Don’t be in hurry to throw out documentation or to abandon the Master Document List.

[email protected]

 

 

Posted by & filed under ISO9001:2015.

 

 

ISO NEW CLAUSE STRUCTURE

 

From the latest information available to me, the ISO9001:2015 will carry new clauses from 1 – 10. Clauses 1, 2, 3 will be Scope, Normative references and Terms and Conditions, as before.  Clauses 4,5,6,7 will fall within PLAN; Clause 8 under DO; Clause 9 under CHECK; Clause 10 under ACT.

 

Many of the clauses will cross-reference. The information below is my interpretation of what the new clauses mean for quality system development based on my experience and development of quality systems over 27 years. They are simply based on good business practice. Much of this is covered in the QUALIDOC INTERNAL AUDIT CHECKLIST which is available free of charge on this website.

 

I invite you to follow my blogs in which I explain, line by line, the application of the new clauses to current quality systems. (See sample QUALIDOC documentation available at www.qualidoc.co.uk also). The text in bold is my indication to pay particular attention to the statement. When you are answering the questions implied in the clauses, always ask yourself the question: WHO NEEDS TO KNOW?

 

Clause 4: Context of the organization

  • ·        Understanding the organization and its context
  • ·        Needs and requirements
  • ·        Scope
  • ·        Management System

 

4.1  Understanding the organization and its context

Here’s where you identify external and internal issues that affect your business. Ideally these should be covered whenever a contract is in the offing. Consider how the requirements of the quality system, e.g., ISO9001, AS9100D (AS9101 Revision E issued recently) can affect your organization. Include this in your Contract Review (Customer Requirements) NOTE: MAKE SURE YOUR MEASUREMENTS (e.g.,KPIs) DO NOT LAG BEHIND DEVELOPMENTS SUCH AS THOSE IN:  

  • ·        key drivers and trends which can have an impact on the objectives of the organization, including customers changing needs;
  • ·        relationships with, and perceptions, values and expectations of, external interested parties;
  • ·        the social and cultural, legal, regulatory, financial, technological, economic, natural and competitive environment (international, national, regional or local);

INTERNALLY: review organizational structure (including Board of Directors level), roles and accountabilities, (responsibilities and authorities) especially those with signing authority and responsibility at critical stages of product or service planning, development and delivery. 

Do you have the policies, procedures, objectives, including strategies to achieve the organization’s objectives? Are resources in place including information (e.g., capital, time, people (skills, experience), processes, systems and technologies)?

Are reliable information systems in place to allow uninterrupted, timely and accurate flow, responsibility and authority (e.g., approval for processes and management decisions, formal and informal)?; 

What are the standards, guidelines and models adopted by the organization?

Contractual relationships: do these include “grouping” with other subcontractors?

WATCH MY BLOG FOR THE NEXT CLAUSE – “NEEDS AND REQUIREMENTS”. SAVE YOURSELF TIME AND MONEY – SIGN UP FOR THE DOCUMENTS ON THE WEBSITE.

 

 

 

 

 

 

Posted by & filed under Uncategorized.

On one of my contracts I  asked to see the Certificate of Com­pliance from a accredited calibration agency be­cause I concluded that the ‘certificate’ on file was simply a Work Order issued by the technician who had checked the equip­ment. The WO only referenced the certificate number. I wanted the proper certificate to be on file and listed in the Master Document List.

My request languished until the day of the assessment, despite many requests from the QAM. Of course the assessor wasn’t satisfied with the document we had on file. We faxed the calibration agency insisting that we get the proper certificate sometime that day. What we actually received was another copy of the Work Order used by the technician who had calibrated the equipment, with the original certificate number whited out and another number written (hand-written) above. Unfortunately, this came into the assessor’s hands as he was standing by the fax machine with the QAM. I was standing to the side and he turned to me and commented to me that he considered it to be fraud (which it was).

The Operations Manager put in a personal call to the calibration agency to request the certificate. The owner of the agency said that he wasn’t prepared to send a copy because “people sometimes altered the certificates in their own favour”. (I don’t know what he means either). He did eventually agree to fax a copy to the assessor’s office.

The moral of this story is to check, check and keep checking the effect of subcontractors, and their documentation, on the integrity of your quality certification. The time wasted above, let alone the threat to the certification, could have been avoided by being alert to the suitability of documentation that purports to verify the status of your quality system.

 

And, of course, all documents should be verified by responsibility authorities and their revision status impeccable.

Posted by & filed under Uncategorized.

 

I am always surprised at the attention and time paid to produce   “mission statements”.  My view has always been that my clients are entitled to the very best I can do because they are paying me and have put a considerable amount of trust in the outcome of my service; it’s as basic as that.

I would be pleased to hear from anyone who has bought an item or service based on a mission statement. I am convinced that customers are not interested in promises or elaborate statements of goodwill. They want to know if you can provide what they want, when they want it and at a price that doesn’t frighten them to death.

Having said that, I have found the quality policy outlined below, which I have used as part of my quality policy manual for many years,  has always been well accepted by assessors, and (after careful scrutiny and agreement as to the content), by my clients.

The assessors can check this statement of commitment easily against the rest of the policy manual and the quality assurance procedures that support the policies. It should also prevent senior executives from producing flamboyant statements about the business which have no basis in reality.

I have tried to keep the statements within a practical business environment to give CEOs and other senior executives a starting point in recognising where these statements relate to their business. The opening statement obliges them to really think about what the business is all about and how they would want it described on the accreditation certificate.

For example, careful attention should be paid to whether or not design is included in the business scope. If no designs are developed or purchased for inclusion in the product (including those provided by suppliers) then an exemption can be claimed for that part of the standard. If you are not sure then it pays to discuss the scope of your business with the assessor of choice before completing the application. The time and attention you pay to this will be well worthwhile.

 

 

QUALITY POLICY MANUAL

MANAGEMENT RESPONSIBILITY AND AUTHORITY

Quality Policy

 

1                    I.M. Happy Company (hereafter referred to as IMH) is in the business of designing and producing (insert concise and precise description of your company’s product or service).

2                    IMH management believes that the responsibility for supplying consistently reliable products and service requires the full commitment of every IMH employee.  To achieve and maintain this commitment, employees are trained in quality assurance policies and procedures and in programmes such as Health and Safety in the workplace, Drugs and Alcohol Abuse, and Environmental awareness.

3.         IMH quality assurance is established by formal written procedures, working instructions and sufficient inspection throughout all phases of production and service carried out by IMH staff. The IMH commitment to the quality system is expressed in the company Quality System Manuals and associated documents (hard copy and on-line), which comply with the ISO9001:2008 standard.

4.         The IMH quality objectives are reviewed regularly by senior management.  Commitment to the quality programme begins with a review of customer requirements and continues through all aspects of product development and customer support.  Every effort is made to ensure prompt detection of, and response to, deficiencies in production and customer service.

5          Levels of customer satisfaction are monitored regularly to ensure that current and future requirements and preferences are met.  This commitment to quality and continuous improvement extends to suppliers, who are involved closely in IMH quality assurance requirements.

6          Quality planning includes activities and resources needed to achieve quality objectives, such as verification activities and personnel, criteria for acceptability and quality records required to maintain customer confidence.

________________________

CHIEF EXECUTIVE OFFICER

 

This policy statement shows that at least you are aware of the commitment involved in developing and maintaining a quality system, which is what the assessor wants to see and confirm during the certification audit.

If you assume, however, that you need not choose your words with care when describing your business, consider the words of a well-known writer from an earlier age.

“Neither can his mind be thought to be in tune, whose words do jarre; Nor his reason in frame, whose sentence is preposterous” Ben Jonson.

(Benjamin Jonson, c. 11 June 1572 – 6 A

Posted by & filed under Uncategorized.

Electronic signatures need the same control, if not more, than written signatures.

 

If you use electronic signatures in your business, or have plans to do so, it is worth bearing in mind the following:

 

  • Each signature should be unique to an individually authorised person
  • Signatures should not be reused by, or reassigned, to anyone else.
  • The identity of the person holding each assigned signature should be verified before assigning, establishing, certifying or otherwise sanctioning signatures  

Don’t forget to add electronic signatures to your Signatories List, which you should have for all persons authorising critical quality system processes, policies, procedures. These will include all signatures required for quality management systems such as ISO9001:2008  (to be reissued as ISO9001:2015).

Include the Signatories List in your regular internal audits.

As an extra precaution, I would identify authorised electronic signatories during contract negotiation. This could save last-minute changes when contract processes are underway, and allow you to keep an eye on staff changes, vacations (holidays) and other times when the signatories might not be available.

Posted by & filed under WHAT MIGHT ASSESSORS LOOK FOR?.

Make sure everyone knows through your working instructions and training that they recognise nonconforming items through tags, labels, marking, segregation in well-marked quality control segregation or quarantine areas.These areas can be laid out on the floor with special marking, or just be a box for smaller items provided it is suitably marked.Whichever method you choose it must be secured for nonconforming items only.

I remember working with a Maintenance Superintendent for a freight forwarding company who had the job of isolating and identifying nonoperational forklifts. They were removed to a corner with a small (grubby) tag marked ‘DO NOT USE’ attached to each one. Unfortunately, during the night shift. operators would decide that they needed an extra forklift. or another forklift would go out of action, and they would take one of the deficient forklifts back into operation. Much curs­ing and frustration occurred the next day as the unfortunate Maintenance Foreman had to waste time tracking the wherea­bouts of the missing forklifts.

Of course, the identification was inadequate for the job it was supposed to do. We devised a much larger identification: a big tag with a skull and cross bones and the words ‘DAN­GER DO NOT MOVE!’ The tag carried a serial number (be­cause it was a controlled document), a Work Order number and a brief account of why the machine was out of action (leaking oil, gears seized). As soon as the machine was re­ported out of action (usually by the operator), the Foreman or other authority would attach the tag, after obtaining a Work Order number from the Repair Shop Work Order Log. The tag would carry an NCR number so that the item would be absorbed into the quality system, with corrective action.

We made it as simple as possible for employees to understand and respect the status of the ma­chine as soon as they looked at it. Too often people will sim­ply not follow procedures if they are not presented in suffi­ciently dramatic or sizeable terms to attract attention, espe­cially when they are in a hurry, or working under extremely difficult conditions.

 

Posted by & filed under WHAT MIGHT ASSESSORS LOOK FOR?.

 

Well-maintained Inspection, Measuring and Test Equipment is important for verifying the status of continuous improvement in company processes as well as accuracy of the product or service.

Assessors will be looking for Inspection. Measuring and Test Equipment to be cali­brated by an accredited subcontractor whose certifica­tion can be traced to national or international standards. A typical list would include gauges. micrometers: anything that needs to be calibrated regularly to maintain its status as a valid measurement for critical parts of the product or service.

Care of the equipment is essential. I have found delicate instruments pushed into drawers and covered with dust. Assessors will check that:

  • The equipment carries stickers showing the date of calibration and the stamp of the accredited agency’s representative responsi­ble for the calibration.
  • Equipment is suitably protected commensurate with its fragility.
  • An ISO label (sticker) or other applicable verification is attached to the equipment in addition to the calibration status label.
  • The applicable certificate with current status  is issued at the time of calibration.
  • The certificate shows the dates within which the calibration is valid.

If your employees are using their own inspection, meas­uring and test equipment for verifying the accuracy of items, processes or conditions in the qual­ity system make sure it is included in the IM&TE maintenance schedule.

If the owner of the equipment leaves the company or is assigned to duties where use of his or her equipment is not required, remove the equipment from the IMTE list.  If it is passed to another employee who uses it for the same purpose, or another quality-critical measurement, its status must be maintained on the list.

Equip­ment which has missed the scheduled calibration date must be labelled ‘DO NOT USE FOR CODE WORK’ or similar warning, and segregated until its calibration accuracy is restored or it is removed from use.

 

See also procedures available to registered subscribers at www.qualidoc.co.uk

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Posted by & filed under MANAGEMENT RESPONSIBILITY AND AUTHORITY: QUALITY MANAGEMENT STANDARDS.

Given the never-ending discussions on measurement my readers might find the following expansion of Management Review responsibilities and authorities helpful in deciding what should be measured for customer satisfaction and customer improvement. The standard only requires that measurement and analysis should take place within these contexts; it does not prescribe methods or identify what should be measured.

I am increasingly concerned about the emphasis on assigning numbers to conditions. Too much time is being wasted on identifying what is measurable without considering which measurements are beneficial to the company and the customer, which should be the only criteria for measurement.

MANAGEMENT REVIEW AGENDA for I.M. Happy Company (IMH)

 

REPORTS

 

QUALITY MANAGEMENT REPRESENTATIVE (QMR)

  • Status of Actions from last Management Review
  • Report on quality system development
  • Work in hand on the quality system
  • Risk assessment and risk management for unresolved nonconformities (e.g., supplier, effect on delivery of services to customers)
  • Changes which could affect the quality system (regulatory, industrial codes, international standards)

CEO

  • Status of Actions from last Management Review
  • Resources needed for quality system tasks
  • Identify position of quality system development in the IMH business development plan
  • Risk assessment and risk management
  • Performance of services, operational processes, associated practices
  • External changes which could affect the quality system (legislation, industry standards)
  •  Quality planning and objectives (needs and expectations of customers and other interested parties)
  •  Business decisions as assessed for their impact on the quality system
  •  The impact of the quality system on business decisions

OTHER ATTENDEES

  • Preventive action strategies (risk assessment and risk management)
  • Quality objectives (strategies for continuous improvement)
  • Cost of quality system
  • Benefits of quality system
  • Training
  • Customer satisfaction levels (implied needs, measurement and analysis techniques)
  • Customer complaints
  • Changes which could affect the quality system

Preventive Action strategies

  • identify items and conditions for improvement in IMH processes
  • identify what has been done to date (e.g., improvement in processes,  equipment, staff training)
  • Refer to QMR reports for possible improvements

Quality Objectives

Identify all components of IMH services which are affected by quality system development, e.g.;

  • Customer requirements
  • What is happening to our customer (changes that would affect IMH services)
  • Resources required (e.g., equipment, skills, labour, time)
  • Training
  • Processes (administration, production)

Cost of quality system

  • Cost of quality system; e.g., staff time, consulting fees, equipment, staff training
  • Projected costs for quality system development during, and until,   assessment and certification stage

 Benefits of quality system

  • Identify benefits to date; e.g., production time saved, processes clearly understood and verified by users, authority and responsibility identified

 Customer Satisfaction levels and customer complaints

  • Identify method(s) for measuring customer satisfaction.  What constitutes customer satisfaction for IMH customers?  Where is this not happening?  How can we improve our service to customers? (anticipating customer needs at quotation and contract stages). These might not be contained in the Request for Proposal or Quotation from the customer.

Measurement and Analysis techniques

  • Identify trends which can be measured; e.g.,  nonconformity, market trends (measurements must be beneficial to the organisation and improve organisation’s performance)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Posted by & filed under THE ISO9001 CHALLENGE.

First, allow me to wish everyone a very healthy and happy New Year. I hope my blogs will be useful and help you navigate the often stormy waters of quality system management.

Training for ISO9001 implementation can often be difficult. For example, I once trained a Quality Assurance Manager who was extremely good at picking up the detail and was dedicated to the job, although she had other duties to do. This is a very common situation which creates many difficulties for me and for the trainee QAM. We achieved a very good result in the audit, even though we were up until 3 a.m. the night before completing the Master Docu­ment List.

Unfortunately, after a resoundingly successful result, the idea of being a ‘Manager’ went completely to her head. and she made life unbearable by adopting a very authoritarian manner and upsetting workshop employees who, at the beginning, had been very co-operative. About four months after regis­tration, I got a panic call from the President, who told me that the quality system was costing a huge amount of money because everything was being done strictly according to the procedures, which had not been changed since the audit. She asked me to come in and see what I could do to ‘loosen things up’.

When I arrived, I noticed a very sullen atmosphere in the office and the shop. The QAM complained to me that no one co-operated and they were not completing the documents according to the procedures. I asked her if she was monitor­ing the quality system for possible changes (‘continuous im­provement’) and reporting her recommendations to senior management. Unfortunately. she did not see this as part of her job, and was probably unable to do it anyway. I could not budge her from her view that her position as ‘Man­ager’ was all-prevailing over the quality system. She spent all her time making sure everyone toed the line, instead of evalu­ating a quality system that was a year old, and could cer­tainly have been improved. Eventually, she was replaced, which cost a great deal of money and aggravation for the company, whose employees had to undergo yet another change of management pace.

My clients often assume that training the Quality As­surance Manager (or management representative) to be a manager is part of my job as a consultant. While I expect to train the incumbent or candidate for QAM in quality system policies and procedures, I can’t make managers out of them if they haven’t the potential. So many attributes are required to make a good Quality Assurance Manager, besides being able to implement the quality system. QAMs must be able to walk a very tight rope between the needs of the quality system and the practicalities of company business, and have a mature outlook when handling difficult employees.

Posted by & filed under ISO9001:2015.

Just received – proposed changes to terminology for the 2015 revision which,  if implemented in the final issue, mean considerable editing of current quality system documentation. I will be suffering; I have to change the offerings on the QUALIDOC website. At least everyone who watches this blog and my website will not be caught napping.

Expected timescales are now-

 Feb 2014- Draft International Standard (or this may be a Committee Draft (2) considering the number of comments received).
Feb 2015- Final Draft International Standard
Sept 2015- Published International Standard

Proposed changes (sample)

  •  “Product” will be referred to  as “goods and services” (but not always)
  •  “Supplier” will be referred to as an “external provider” (but not always)
  •  “Records” as a term no longer exists – it is included in the new term “documented information” (This takes the place of Documentation Requirements).
  •  “Documented Procedure” is included in the new term “documented information”
  •  “Product realization” becomes “realization of goods and services”

 In the current Committee Draft there are no longer requirements for a Quality Manual, Management Representative, and Preventive Action.It will be interesting to see how these are covered; they are important ingredients.

I will be posting more terminology and let you know when my new drafts are available via the website.

 

Don’t panic – amendments could still be made, but just the removal of the Quality Manual alone is a big change. My Quality Manual comprises the Quality Policy and a separate document for Quality Assurance Procedures.