QMS: Clause 7.4 Purchasing

I’m developing a process so as to meet the clause 7.4 (Purchase) of ISO 9001:2008 and I would like your opinion if this process (minimalist) attend the clause in a certification audit. As we are a design, development and production company in the ETO (Engineer – to Order) model, there is always a need for new materials and new suppliers. Following is our process

1. There is a need for a material or service;
2 . Sets up the quantities and specifications of this material or service;
3 . Find possible manufacturers (materials) based on catalogs, datasheets etc. or service providers based on their scope of supply. There is not a list of qualified suppliers, only blocked (disqualified) suppliers.
4 . Carried out quotations with potential suppliers ;
5 . Select one of the quotations evaluating price / term / previous experiences etc. ;
6 . Emits purchase order with a description of the materials and services requirements ;
7 . Await the arrival of the material ;
8 . When the material arrives verify it the material corresponds to the purchase order;
9. If the material appears on a list of critical materials , the item passes through a receiving inspection by quality control personnel, following the criteria established for this material and generating records ;
10 . If there is a non-compliance detected on receipt or at a later stage , return it , rework it or accept as is ; Emits an RNC ;
11 . At the management review meeting show statistics from the last period with respect to suppliers who owned non-conformities ;
12 . Based on the review of these statistics decides whether or not suppliers are listed in the list of disqualified suppliers ( blocked ) . Join this in the minutes of the meeting of management review meeting ;
In short, we need to know is if we can make the management of suppliers based on the exception, ie , can buy from any supplier, provided that this is not in the list of disqualified suppliers ( blocked ) and, therefore , need not to qualify suppliers or maintain a list of qualified suppliers.

When I said that I was developing the purchasing process, in fact I was trying to say that I was adapting the existing process in order to meet the ISO 9001 requirements.

I just described a summary of our entire purchasing process just for you to understand, but what I am more concerned is about the selection, evaluation and re-evaluations of suppliers.

As I have said before, our products may have some similarities, but most of them are “one(s) of a kind” products, designed to meet the customer needs, so each product may need a complete set of new materials and suppliers. To make specific approval and specific evaluation processes (using forms, surveys, technical visits, audits etc) of every new supplier would be very difficult for us to implement considering our size and some times importance for our suppliers.

Most of our materials have the part numbers and suppliers defined by engineers on bill of materials during detailed design phase based maily on datasheets, just leaving to the buyer the responsibility for choosing the distributor with best price, delivery date etc.

Of course there are some materials that are “generic” like resistors, capacitors, o-rings, screws, washers, raw materials, but the main characteristics are defined by engineers on bill of materials. In these cases the buyer choose the distributor with best price, delivery date etc. and the distributor may choose the manufacturer he works with.

When we purchase services, such as machining, welding, painting etc, we base our selection on previous experiences and the capability of the supplier of meeting our specifications.
In any case above, when there are needs for certificates, the need is described on the quotation and purchasing orders, together with drawings, technical specifications, procedures etc.
About evaluation and re-evaluation of suppliers, what I propose to do is to summarize the performance of the suppliers (base on NCRs) on every management review meeting and decide on these meeting if the suppliers go or not to the “black list”. This is enough?

From Fabricio Damico Quality Manager at NAVCON Navegação e Controle

Comments from above questions:

By Nik:

I have two concerns with the process you outlined and clause 7.4.

Firstly, step 5 of the process suggests some criteria are used to evaluate suppliers but I would ensure that these criteria are very firm and rigorous.

Secondly, the process does not seem to include any re-evaluation of suppliers against the selection criteria. Review of non-conformances is good, but unless it is one of your selection criteria, you are evaluating suppliers against a criterion that initially wasn’t applied in the selection decision.

Your process could for example include expected fault rates for supplied products in the selection criteria. Then you could choose suppliers with less likely occurrences of non-conformances.

By Jean:

I will comment your statement from a totally different perspective.
When I read “I am developing a process (for purchasing to meet requirements of ISO)”, I get very concerned.
Many people believe they have to drastically change the processes they used before they seeked certification in order to comply with ISO requirements. This is not true.
I try as much as I can to picture the road towards certification using objective evaluation of an existing situation and using requirements to improve towards customer satisfaction.
Every organization has a purchasing process. For most organizations, ISO implementation will introduce a formal supplier evaluation. Many organization I worked with did not have to change anything else.

By Jane:

Nik makes some good points.
Yes, you can evaluate based on exception – it’s a sensible way to do it.
But I too have some concerns about the lack of criteria for selecting suppliers – your process there sounds fuzzy. If it’s bog standard goods, this may be fine, but surely with critical materials you’d have some important criteria? You see, you talk of evaluating quotes against criteria (price, terms, previous experience etc) so include it in your process of supplier choice.
You do not have to have an ‘approved supplier list’ (that’s a myth) but you do have to manage the process.
Waiting until suppliers produce NCs and then blocking them is corrective action – good planning/preventive action not to mention risk management is to be more proactive in choosing them. Which is what the standard wants.

Conformity assessment vs. Performance assessment Part 2

Most assessments are a conformance / compliance check versus a narrow interpretation of requirements with no effective checks to see whether actual processes / activities, or indeed the entire system as a whole, is consistently delivering customer satisfaction which is what I regard as the performance part.

During an audit I raised that some scorecards being used to track a site’s performance were ineffective for quality performance. The site could have significant product related issues impacting the customer but meet their scorecard objectives.The scorecard appeared to have been designed so the site could consistently report they were meeting objectives. This was a significant issue to me but I was a bit of a lone voice as others were saying “but it’s compliant” or “where does it say what objectives / targets are required?” or “the requirements only say you have to establish objectives & monitor performance” etc.

Eventually I just said meeting these objectives is not consistent with delivering the site’s stated qualtiy policy nor were they aligned to measure or track the delivery of consistent customer satisfaction which was the whole purpose of the quality system.
I was viewed as a bit of a heretic at the beginning but soon everyone saw the light. Unfortunately it is just a drop in the ocean and many CBs appear to have a compliance approach whereas assessing performance is what will ensure I can trust an organizations 9001 certificate.
In some ways conformity assessement versus

Conformity assessment vs. Performance assessment

Conformity assessment is related to intent of the organizations i.e. how well the QMS has been understood and implemented. The outcome would be the extent of adequacy of compliance with respect to the requirements. Do you agree that conformity assessment should include performance assessment, should not, or whether the whole point is moot because conformity and performance are part of a single concept.

The two categories, ‘performance’ and ‘conformity’, are not inherently mutually exclusive, but in practice, they are often set at odds with each other. Process maps, approved supplier lists, training matrices, equipment maintenance logs and internal audit gantt charts get conjured up for the certification body auditor; for no other reason than to keep the auditor happy and to ensure the certificate gets renewed. Most of these are not even required by the standard, but ‘tradition’ dictates that auditors usually expect to see them, so better safe than sorry. Certification is a commercial decision, not a quality-based one, and the QMS is little more than a work of fiction

These records sit on the shelf gathering dust for 11 months 20 days of the year until just before the dreaded auditor turns up and asks to see all this boondoggle output A few token NCRs are raised, which are then closed out shortly afterwards, and everybody pats themselves on the back for a job well done. Then the cycle begins again and rolls on to infinity and beyond.

I have experienced many exceptions to this, and have seen some excellent consultants producing some great work, and some skilled, perceptive auditors discussing implemention of the spirit as well as the word of the standard. I have seen organizations turned round as a result of the introspection and aspiration that accredited certification can facilitate. But I have also seen the extent of the reliance on ‘tradition’ and demands made in regard to non-requirements of ISO 9001 and, finally, the money this wastes.

With the right people under the right circumstances, conformity and performance can, will and should be part of a single concept.

I would like to pick up on the subjective-objective dimension, because I feel it deserves special consideration. It’s something I’ve thought about for many years, right from when I was an apprentice.

I recall two inspectors, each of which had their own instruments and measurement table. The machine shop inspector was known for his uncompromising pedantry; components and their supporting documentation (such as drawings and CNC programs) were either 100% right or 100% wrong. He was deeply unpopular, and his presence at the end of the machining process was profoundly ingrained in the minds of the machinists. He kept his measurement table covered over, in its original packaging, for over 20 years; he would remove part of the packaging (just enough to make space for his measuring devices) while he was inspecting; as soon as he was done, the cover went over again. There was not a scratch on it. He kept his measuring devices in the best possible condition; they never needed replacing and were never found to be out of calibration.

The fabrication inspector was the exact opposite: a folksy, man-of-the-people character, with an excellent relationship with the fabricators. He was able to identify risks to quality and make decisions on product conformity accordingly. His table was battered, chipped, dirty and covered in welding spatter. He was working to tolerances of plus or minus half a millimetre, whereas the machine shop inspector was working to tighter tolerances of 3 decimal places. Did years of working to tight tolerances affect the machine shop inspector? Or was he already of that psychological make-up and thrived in his job because he was already like that? Or was it both?

It was interesting to observe the effects of one of them taking time off work: the more practical approach of the fabrication inspector, when he was covering for the other, caused people to relax and productivity to rise slightly. When the machine shop inspector covered for the fabrication inspector, some fabricators complained to the union or threatened him with physical violence.

In both of the above examples, the inspector was part of the system, acted on the system and was in turn acted upon by the system. Each was using measuring devices that were ‘objective’ measures of quality characteristics, but their attitudes, interpretation of results and effect on quality were very different. I’m reminded here of Deming’s comment on the relationship between control charts and brains.

I’d like to comment on the ‘factual approach to decision making’ management principle in ISO 9000:2005: according to ISO 9000, effective decisions are ‘based on the analysis of data and information’ (p. vi). Taken at face value, this could be an example of the ontic fallacy, where it is believed that phenomenal entities can be projected out onto the world as objective sense data, of which people can have direct perceptual knowledge. Here, knowledge is viewed as a direct, unmediated relationship between a subject (e.g. a component) and its observer. Yet the example I gave of the inspectors shows the complex psychological and social mechanisms operating on and within organizations, and the effects this can have on ‘objectivity’.

Finally, we could ask ‘whose facts’? Ever been served the perfect meal in a restaurant but been upset with the waiter’s attitude? All the objectively-measureable bits (e.g. temperature, seasonings, the weights of the ingredients) were perfectly in place, but the ‘soft stuff’ resulted in a customer complaint (and ruined your evening!) I know some people who do not care about the attitude of the staff, so there are individual differences between customers, and these cannot be measured directly – we can only get to them through social interaction. This is highly problematic: after a bad experience, even when the waiter asks if everything was OK, most people lie and say ‘yes’. Price can also have an effect; if all you want is a cheap, fast meal after a long day at work, then your expectations will probably be much lower.

So I view objectivity and subjectivity as having a complex relationship with each other that goes well beyond something being either one or the other.

I believe that objectivity and subjectivity are not mutually-exclusive categories, and that they interact with each other throughout a product’s life cycle. It is this interaction that results in meeting the customer’s requirement (or not!)

I see any product realization process as a constant interaction between matter and mind, starting right from the customer enquiry, where consensus is reached on the customer’s stated (and unstated) requirements. There are an infinite number of objectively-measurable variables we could choose to manage, when we think of all the phenomena that exist, even in a lump of metal.

We have to make abstractions based on what we believe the customer wants, our experience of the product, our knowledge of the organization and an infinite number of factors that we must reduce to a manageable size. This is probably why there have been so many tools and techniques developed (e.g. house of quality) to aid in this process.

So we ask questions designed to reduce the variables to those we can and need to manage:

What characteristics are important? Why are they important? How shall we communicate these quality characteristics? To whom? How shall we measure them? To what degree of accuracy? Who shall measure them? Using which instruments? What could go wrong? How shall we prevent it going wrong?

All the way, we are forming unique synergies between facts and interpretations, during which the objective and subjective are constantly interacting. Every objectively-measurable phenomenon is subjected to somebody’s judgement; the setting of tolerances is a good example of this; these tolerances were set based on a person’s judgement, even if that judgement was based on science and/or has been institutionalised (e.g. through a British Standard) or automated (e.g. through a CAD package).

Intriguingly, tolerances are often arbitrary and based on standard practices (and very often pre-printed onto the blank engineering drawing template, even before the drawing has been created!)

So the only way to identify and manage quality characteristics is to enter into this dialectic, preventing its diverse movements from running off in opposite directions, but allowing the objective and subjective to weave their synergy and tensive unity through our thinking.

Apologies for diverging so far away from the original post, but I find this area fascinating!

This is indeed a fascinating discussion, and I like the views you express Simon. My interpretation of the main point you make is that a product or service functional specs (expressed by a customer, demanded by the market, or based on supplier formulation) need to interact with a whole array of objective/ subjective elements to result in technical specs related to the required functional expectations.
The interaction between the two dimensions can produce at least four major categories depending on the state of the variables.
1. If the functional specs are not well defined & subjectively evaluated, that may result in product not much relevant to the market needs.
2. If the functional specs are not well defined but objectively evaluated, chances are further investigation is planned before finalizing them into technical specs.
3. If well defined functional specs are available but subjectively evaluated, that situation may take long to result in meaningful technical specs if at all.
4. However, if there are well defined functional specs & objectively approached, chances are best technical specs are achieved.
The objectivity-subjectivity dimension is interacting with the information on customer requirements to produce the relevant outcome.
I am using subjectivity as absence of objectivity, & vice versa. I admit it is not alway the extreme. But the variation is only playing a balancing role.

Performance is very subjective and is dependent on a number of factors that are dynamic in nature. I have worked in the aerospace industry for the better part of 35 years and if there is one constant it is this. A buyer will almost certainly change requirements, development schedules and delivery schedules throughout the course life of a program. Contract changes, ECN’s galore, problem reports, etc. may or may not be directly related to customers actions or inactions. Without an enormous amount of digging through contracts, PO’s emails, ECN’s and PR’s by an auditor, not to mention teleconferences that are rarely documented, just how would an auditor judge performance? It is not possible. Not to mention that good performance as judged by one auditor may be deemed sub-standard by another. Even though most of my career has focused on aerospace, I have worked in other areas as well and the same issues exist. Leave performance out of the certification process.

Discussion taken from Simon Alexander ,Christopher Paris,Dr. M. Rouzbeh,Richard Murdock & others.

QMS lead auditor courses

Have you done anything as simple as doing a Google or Bing search? I just did and got nearly 2 million hits for ISO 9001 Lead Auditor training.Being a lead auditor entails more than just taking a training course, it also involves doing research, looking for answers, taking initiative, being resourceful.

It is very good decision to take one when specially you are a Quality Professional, Lead Auditor Course is one of the most comprehensive way of development and strengthen of your Quality Management System Skills in system development, implementation and up gradations along with accurate understanding of ISO 9001 standard requirements.

I recommended you to just confirm that training organization & Course Facilitator is approved from IRCA (International Register of Certificated Auditors) & course is also IRCA Approved. For your informations IRCA Registered courses are Internationally recognized and with stadardized course work & methodology and IRCA logo is printed on the Certificates which is most important return of your investment.

ISO 9001 Registration: Do we need Management Buy-In?

The answer to the question is a most definite YES – you can. Of course the company will not get all of the benefits but the reason why the unaccredited certifying companies do so well is that the customers of their customers don’t really know the meaning of ISO 9001 etc. and hence it is “theatre” – you have a certificate (the badge) so it MUST be OK.

In general terms the standard of auditors for accredited certifying bodies is not that good and you will attain certification status with a little rehearsal before the audit.
Let us not be too purist about this.

I am NOT condoning it just stating what I find in practice.
I have clients who have retained certification when there is little acknowledgement by the senior management. I, together with the QM, manage to retain a good working relationship with the auditor.
This is a reason why the certifying bodies should make a change to the auditor visiting a client rather than having the same one throughout the certification period.
I shall enjoy reading some of the responses, if there are any. By Malcolm Gibbs(Management Consultant for Business Standards (ISO 9001, ISO 14001, ISO 27001, ISO 13485, OHSAS 18001)

This may be an unpopular response, but it is possible for companies to achieve ISO accreditation without management buy-in. There are reasons for this; such as: the corporate office mandate, customer PO requirement, managers not understanding the significance of ISO, managers not being trained on their role in supporting ISO, etc. All it takes is one ISO expert, a pile of money, a little time and an ISO registrar who is led to believe that there is management support; and BINGO; a certificate is granted. However, If management is not engaged in the leading or supporting the program, the Company will not gain the benefits of the journey nor will they reap the cost savings and improvement opportunities. It is better to wait until managers are trained, motivated and committed to the concepts of quality system and process improvement before the ISO journey is started. A better question might be: Who’s role is it to convince management of the benefits of quality system improvements? By Ron Tuznik (Quality Engineering Project Manager)

We need a definition of ‘buy-in’. Buy-in occurs when a meaningfully constructed QMS has been designed collaboratively by the leadership team with the intent of following it because it captures how the organization will succeed doing business.
It is naïve to believe the purchase of certification constitutes ‘buy-in’. It is not ‘buy-in’ if a quality manager must police the organization to maintain the certification. A flurry of activity by the QM prior to ISO audits in order to make sure all outstanding NCs have been corrected, any improvements noted, etc. is akin to sweeping parking lots and painting handrails prior to senior corporate visits. By Scott Robertson(Business Improvement Specialist at Diavik Diamond Mines Inc.)

Do not implement a management system especially for certification. Instead develop your organizational management system to create more successful customers. Do not “implement ISO 9001″. It is better to understand and develop the management system that actually runs your organization.

Ask yourself “is my quality management system worthy of top management commitment?” If it is “yours” then it probably is not worthy especially if its main focus is on controlling documented information, inspection and controlling nonconformity or some other preoccupation of the Quality Department.

Focus instead of what your organization does to convert the needs of customers into cash in the bank (or continued funding). This is the system that needs to be improved by top management’s management system. Make this a reality and never worry about such top management commitment again. By John Broomfield (Senior Vice President at Quality Management International, Inc.)

ISO 9001 Questions: ISO consultant is the Management Representatives (MR)

ISO 9001 Questions:Is it possible that appointed ISO consultant for the company is the Management Representatives (MR)?Will this appointment have problems if being audited by 3rd party auditor (Certification body) while having the MR present during the audit sessions?

ISO 9001 Answers:
There is a difference between someone being part-time (but still “staff”) and being an external consultant (which was the question). Consultants are contractors, they invoice the company for their work and are selected and managed subject to the requirements of clause 7.4. Temporary staff are on the payroll and their competence is subject to evaluation not under clause 7.4 but under 6,2. If an auditor can’t tell the difference that is his problem not the fault of the company. Under the explicit terms of clause 5.5.2 one of these state of affairs is OK for the MR, one is not. “Part-time” is not an issue. I know a few of MD’s who are part-time.

We have, as usual, ended up in an argument that pointlesslessly splits academic hairs and loses all practical context. The reason clause 5.5.2 requires the MR to be a member of management is because a dynamic is needed to shift inertia and make things happen, particularly when there is indifference and non-co-operation. Either the MR has the power to exert a force when necessary or he/she has to go to somebody else to bang heads together. If the alleged “MR” does not have the authority to crack skulls, then he/she is the wrong person. In actual fact the real MR is the person they report to, just as in the case where a consultant is the alleged “MR” the real MR is normally the person that signs off his/her invoices.On the subject of the acceptability of a consultant as the MR, it’s purely an academic argument. A consultant is practically never going to have the authority to manage and, more pertinently, discipline employees – something “authority” brings with it.

There may be occasions where consultants and contractors are considered as “staff” with similar responsibilities, but these are generally in quite narrow technical fields. It’s common for there to be a mix in software/system development teams where it’s difficult to tell staff from contractors. The MR role is broad and requires (as stated in the standard) authority across the entire system. Never in a million years are you going to encounter a consultant with that vested power, no matter how long we may be prepared to debate the theoretical possibility of it. I’m not even sure about the legal position of a consultant taking disciplinary action on a full time employee. I have a feeling it’s legally invalid.

if the company wishes to comply with ISO 9001 it cannot pick and choose which of its contractors it evaluates and monitors unless that contractor does not perform work related to quality. I would argue the MR, as it is a specific requirement of the standard in question, could not under any circumstances, be considered a role not affecting quality. I am sorry but I cannot follow your arguments at all. Suggesting the MR is a role that does not affect quality when it is an explicit requirement is patently absurd.

Fundamentally I am unsure whether (notwithstanding your self declaration of being an expert) you actually understand the intent of clause 5.5.2. “The organisation shall appoint a member of its own management … ” – how much clearer do you wish the requirement to be stated?

The MR requirement does not require ANY technical competencies or ANY quality management knowledge or experience. The MR is simply a member of the company’s board who is nominated to ensure things happen when they need to. I have been in this situation professionally many times working as a consultant I AM NOT SPEAKING HYPOTHETICALLY. On one assignment I was embedded in an international bank full time for 6 months and did more or less everything technically associated with the quality system, but I WAS NOT the MR. I reported to the customer services manager – he was the MR. If I needed skulls to be cracked I went to him. Apart from that he did very little, but what little he did was 100% required by the MR role.

I can’t help but get frustrated when people examine the words of the standard under a microscope in order to identify preposterous but theoretical ways a company could literally conform. Does the standard even say the MR needs to be human? No, it doesn’t, so it could be a cat.
Sources: Shaun Sayers

Sub Clause 5.5.2 of ISO 9001:2008 requirement should has revise, because its scope to appoint a MR is narrow to organization’s internal management team member only. MR might is a external quality professional. However, quality/QMS consultants have relationships with external QMS auditors, even they are also external QMS auditors. Therefore, when the organization hires a external quality/QMS consultant to hold MR role, this can cause objectiveness missing when external QMS auditors perform kinds of audit to organization’s QMS. Source:Phuoc Nguyen

If an organization really seeks benefits from implementing ISO 9001/QMS, it shall not appoint a consultant as an MR. Also the clause 5.5.2 mandates a person FROM/within the organization be the MR. A consultant is NOT a person from/within the organization.

There will be at-least 4 people even in a small organization at its decision making level and the top management can select anyone of the 4 members to be the MR.

From my experience, I would prefer a Sales Head or an R&D Head or a Quality Head (where quality is strictly followed) to be the MR as they know well about their organizational products current customer satisfaction level and the market/stakeholders expectation. Source:Antony Joseph Jenish

rom my own personal experience; I’ve seen two reasons for a consultant being hired as the MR? And YES! I”ve seen this situation, so it’s not hypothetical.

1) A small company does not have anyone with the expertise knowledge in the overall QMS and ISO 9001 system; so they hire a consultant for perhaps 1-2 years to train all the employees, and management on the various aspects of ISO and the QMS; along with other topics such as 5S, Lean Mfg & Operations, RCCA, etc — until someone is knowledgeable enough to take over.

2) A small company does not have the staff to re-assign someone from their current responsibilities to assume the MR role; and the company does not have the budget to increase it’s employment staff. (NOTE: keep in mind that adding a contract consultant does not incur the extra HR expenses associated with a full time employee – health insurance, etc.). There could be good a business case for hiring executive staff consultants for a company rather then a full-time employee. I even know of a company in which their General Manager is a part-time consultant, working only 3 days per week, and not a regular employee. Source:Jim Dent, LSSBB

ISO 9001:2008 -Decision of Quality Policy

Decision of Quality Policy shall related directly towards Managing Director and it shall be review for continuing suitability, adequacy and effectiveness of the existing quality policy at the end of year and enact new quality policy for the next year.

The quality policy itself should be fulfill below purpose and target as per company direction and visions. Decision of Quality Policy shall be
a) appropriate to the purpose of the organization,
b) includes a commitment to comply with customers’ requirements and continually improve the effectiveness of the quality management system.
c) provides a framework for establishing and reviewing quality objectives,

Of all above Decision of Quality Policy it should be driven from early company calendar book and reviewed its effectiveness during the Management review conducted at least once a year.

ISO 9001:2008 -Calibration Traceability and calibration status

Calibration Traceability
All equipments mentioned in document master list shall be calibrated internally or externally against a reference standard which in turn is calibrated against a more accurate standard. Reference standards at organization are traceable to external calibration labs (Sirim, Sirim-Sime, Sendi-Mahir, etc). Organization Calibration Traceability is mentioned in checklist.

Equipments Calibration Status.
The status of equipment shall be decided based on the calibration result. If the result is good, the equipment shall be indicated with Calibration Sticker. If the calibration result is no good, the equipment shall be stick with “Out of Order” sticker and recorded in the Damage Equipment Report for further action .

If the equipment is found no good after repairing, it should be considered for scrap and recorded in Measuring Equipment Scrap Report . All the previous calibration record and report should be filed together with this Scrap Report. The Section in-charge shall decide on the purchasing of new equipment.

For new-purchased measuring equipment, Measuring Control shall identity either this equipment need or no need calibration. If need calibration, it must be registered in master list and calibrated before using. If the result of calibration is satisfactory, the equipment will be issued to the user section. The flow of calibration for new equipment is as per Appendix . If this equipment is no need calibration, it should be stick with “No Need Calibration” sticker

Food Safety Modernization Act

By end of last year, the Food & Drug Administration released the Food Safety Modernization Act. So for those who actually in Medical and food industries should already know about this.However, just in case, i share it here for thoughts and reminder. This new act requires importers to verify safety of foreign foods. Framework following as per ISO 22000, which include also the food GMP are now required by big food distributors and importers from their suppliers. The ISO 22000 certification process, which includes HACCP and cGMP compliance, by a third party or Registrar has become compulsory for domestic and foreign food manufacturers and processors .

In the other way to describes it, that the new FDA law explicitly places primary responsibility for food safety – for prevention – on food producers and processors. The new importer accountability provisions require importers to implement a foreign supplier verification program. They will need to provide adequate assurance that imported foods have been produced under appropriate risk-based preventive controls that provide the same level of public health protection as those required of the domestic food industry. The FDA inspection now require may asked for an accredited third-party certification as a prerequisite for the importation of high-risk foods into the U.S. when they believe it necessary to protect the health of our consumers. Based on summary of this newly Food Safety Modernization Act, it is understandable that FDA inspection shall be quite tough from now onwards when this act adding into the system.

Environmental Warranty of Non-Inclusion of Hazardous Substances in Products

Example of Environmental Warranty of Non-Inclusion of Hazardous Substances in Products .Also included statement on compliance to Sony SS-00259 Standard.Refer below.

To: Customer

Ref.: Warranty of Non-Inclusion of Hazardous Substances in Products.

1. Product Name

Dear Sir / Madam,

Our company hereby warrants and guarantees that all of or parts of products, including, but not limited to, the peripheral, accessories or packages, manufactured and / or delivered to your company (including subsidiaries and affiliated companies) directly or indirectly by our company (including subsidiaries and affiliated companies) are free from any of the substances listed in Sony SS-00259 Standard or its subsequent revision, including the following substances.

1. Cadmium and cadmium compounds.
2. Lead and lead compounds.
3. Mercury and mercury compounds.
4. Hexavalent chromium compounds.
5. Polychlorinated biphenyls (PCB).
6. Polychlorinated naphthalenes (PCN).
7. Polychlorinated terphenyls (PCT).
8. Short-chain chlorinated paraffins (SCCP).
9. Other chlorinated organic compounds.
10. Polybrominated biphenyls (PBB).
11. Polybrominated diphenylethers (PBDE) (including decabromodiphenyl ether [DecaBDE]).
12. Other brominated organic compounds.
13. Tributyllin compounds (TBT).
14. Triphenyltin compounds (TPT).
15. Asbestos.
16. Specific azo compounds *
17. Formaldehyde.
18. Polyvinyl chloride (PVC) and PVC blends.
19. Beryllium oxide.
20. Beryllium copper.
21. Specific phthalates (DEHP, DBP, BBP, DINP, DIDP, DNOP, DNHP).
22. Hydrofluorocarbon (HFC), Perfluorocarbon (PFC).
23. Perfluorooctane sulfonates (PFOS).
24. Specific benzotriazole.
25. Cobalt dichloride.
26. Ozone depleting substances (ODS).
27. Dibutyltin compounds (DBT)
28. Dioctyltin compounds (DOT)
29. Tris(2-chloroethyl) phosphate (TCEP).
30. Hexabromocyclododecane (HBCDD)
31. Dimethyl fumerate (DMF)
32. Diarsenic trioxide, Diarsenic pentaoxide.
33. Hydrofluorocarbon (HFC), Pentafluoracarbon (PFC)
34. Boric acid, specific sodium borates.

*Not applicable for colour wire.

Table 1: Specific Azo Compounds.

No. CAS No. Amine Compounds No. CAS No. Amine Compounds
1 92-67-1 4-aminodiphenyl 12 119-93-7 3,3’-dimethylbenzidine
2 92-87-5 Benzidine 13 838-88-0 3,3’-dimethyl-4,4’-diaminodiphenylmethane
3 95-69-2 4-chloro-o-toluidine 14 120-71-8 p-cresidine
4 91-59-8 2-naphthylamine 15 101-14-4 4,4’-methylene-bis-(2-chloroanilene)
5 97-56-3 o-aminoazotoluene 16 101-80-4 4,4’-oxideaniline
6 99-55-8 2-amino-4-nitrotoluene 17 139-65-1 4,4’-thiodianiline
7 106-47-8 p-chloroaniline 18 95-53-4 o-toluidine
8 615-05-4 2,4-diaminoanisole 19 95-80-7 2,4-toluylenediamine
9 101-77-9 4,4’-diaminodiphenylmethane 20 137-17-7 2,4,5-trimethylaniline
10 91-94-1 3,3’-dichlorobenzidine 21 90-04-0 o-anisidine
11 119-90-4 3,3’dimethoxybenzidine 22 60-09-3 4-aminoazobenzene

Thank you.

Yours sincerely,