BRC Packaging & Packaging Materials Issue 6
In less than four months, a new issue of the BRC Packaging and Packaging Materials standard is expected to be released. It is still on track for publication on August 1, 2019. DQS Inc. was fortunate to have two members of our leadership team – Mike Pearsall, Director of Food Safety Business Development, and Ron Bergamasco, Food Safety Program Manager – able to participate in the development process. After the estimated publication in August, there is a transition period of six months. The use of Issue 6 is compulsory for all certification audits taking place from February 2020 onwards. Prior to that date, it is not possible to be certified according to the new version.
As a reminder on the changes, we have an article from our colleagues at DQS CFS on the changes below.
The new BRC Global Standard for Packaging – Issue 6 includes six major changes: two key changes concerning the protocol and four key changes regarding the requirements of the former Packaging and Packaging materials – Issue 5 certification.
While reading please keep in mind that the requirements and protocol are still subject to change.
Changes to the Protocol
- Removing the second hygiene category – In Issue 5 there were two categories of requirements, depending on the intended use of the packaging material – high hygiene and basic hygiene. Removing the two-category system simplifies the use of the new standard. The differing hygiene levels will be replaced by a risk-based approach, based on only one set of requirements. Some requirements will have a higher or differing level of hygiene that applies to “food contact materials”.
- Removing second/split unannounced audit option – Version 5 of the BRC Global Standard for Packaging offered three audit options: Full announced audit, full unannounced audit, and split unannounced audit. The last one divided the audit requirements into two separate audits, the first one unannounced and the second one announced. Reflecting that the full unannounced audit option is generally preferred because it gives extra confidence to specifiers, Issue 6 will be in line with Issue 8 of the Food Standard by removing the split unannounced audit option. Unannounced audits remain optional.
Changes to the Requirements
- Corrective and preventive action: fundamental clause – The new version of the standard integrates specific requirements on corrective and preventive action (CAPA) related to root cause analysis into a structured continuous improvement approach. This way the root cause analysis is assembled in one paragraph, in line with Issue 8 of the Food Standard, emphasizing the importance of addressing issues with the intent to remove the risk of re-occurrence and supporting continuous improvement. This is a fundamental clause, which means that sites that have not implemented this clause cannot be certified. The fundamental clauses are marked with “FUNDAMENTAL”.
- Emphasis on product quality – BRC Global Standard for Packaging is not just a hygiene standard – its scope covers both product safety as well as product quality. Issue 6 places even more emphasis on product quality and clearly distinguishes between safety and quality. In the hazard and risk analysis (HARA), Issue 6 separates hazards into product safety and quality defects to improve control measures necessary to prevent, eliminate or reduce each product quality hazard to acceptable levels (2.2.6).
- Product safety and quality culture – Issue 6 emphasizes the importance of the culture at a site. It does so by introducing a new clause (1.1.2). The clause requires sites to set up, execute and review an action plan to improve product safety and quality culture. This does not imply that the auditor will assess the culture of the organization, but rather that (s)he examines the efforts made to document the status of the organizational culture and the steps that are put in place to improve it.
- Pellet, flake and powder control in the plastic industry – Section 8 of the BRC Global Standard for Packaging – Issue 6 acknowledges the importance of raw material management in the packaging industry with the intention to remove new plastic contamination from food supply chain. This regards the removal of risks of cumulative chemical contamination of the human food chain and removing the risk of starvation of fish and marine mammals. Section 8 is applicable to the conversion of polymer from pellet, the use of flake or powder and the use of hot melt glues, particle raw materials etc.
Occupational Health and Safety Management Systems – ISO 45001 update
For those of you eagerly awaiting an update on the Occupational Health and Safety Management – ISO 45001 standard, here it is.
The most recent round of voting on the ISO DIS 45001.2 has resulted in majority approval and can move forward towards publication. The ballot indicated 57 votes of approval, 7 votes of disapproval and 8 abstentions.
The next step will take place in September of 2017, when the PC 283 committee meets in Malaysia to review the approximately 1630 comments received on the Draft International Standard (DIS). At that time, the committee will determine if the standard will be moved directly to publication, which would mean potentially by the end of 2017, or if an FDIS (Final Draft International Standard) will be necessary. If an FDIS is deemed necessary, it would delay publication until 2018.
It is intended that the ISO 45001 standard will help organizations reduce the burden of occupational injuries and diseases by providing a framework to improve employee safety, reduce workplace risks and create better, safer working conditions, all over the world.
Currently, many organizations use OHSAS 18001 for minimum requirements for occupational health and safety management best practice. The intention is that OHSAS 18001 will be replaced by ISO 45001 when published.
DQS Inc. is closely monitoring the development of this standard and is preparing to apply for accreditation as soon as the opportunity is available as well as preparing to offer certification services.
More to come on the progress of this standard after the September meeting!
DQS Inc. Attains ISO 13485:2016 Accreditation
IATF 16949 Revision
IATF 16949 available for purchasing; deadline for transition is 14 September 2018
IATF 16949 was published on October 3, 2016. From now on, organizations will need to adjust to the new requirements and start on their implementation.
The International Automotive Task Force (IATF) further confirmed September 14th, 2018 as the deadline for transition to the new standard in accordance with the new ISO 9001:2015. This implies that by that date at the latest, all ISO/TS 16949 certificates shall have been transferred to the new standard.
Based on this and with respect to the tight timeline, we would like to give you some additional information regarding the transition process as defined by IATF.
The Transition Process includes the following steps:
- Document review (off or on-site)
- Transition audit
- Nonconformity management
- Certificate decision
- Certificate issuance
Time of Transition
Voluntary transition may be scheduled at the next planned surveillance or recertification audit any time between 1 January and 30 September 2017. Starting 1 October 2017, all audits shall be conducted to IATF 16949.
According to IATF, the transition audit shall be the duration of a re-certification audit as given in IATF Rules, Table 5.2. If document review has to be conducted on-site due to documentation not being submitted in advance, an additional 0.5 days minimum will be carried out prior to the preliminary meeting.
Main Content Changes
In addition to ISO 9001:2015, we expect the following new/changed requirements:
- Requirements for safety-related parts and processes
- Enhanced product traceability requirements to support latest regulatory changes
- Requirements for products with embedded software (Automotive Spice)
- Warranty management process including addressing NTF (no trouble found) and use of automotive industry guidance
- Clarification of sub-tier supplier management and development requirements
- Addition of corporate responsibility requirements
DQS Recommendation for Transition
Even though the deadline is September 14, 2018, the Transition Audit should be finished by June, 2018, in order to allow the passing of a certification decision as well as issuance of the new certificate well before the current certificate expires.
Keeping in mind the short timeline, DQS recommends any organization currently certified to ISO/TS 16949:2009 and needing to transition to define their own schedule for the Transition Audit by the end of December 2016 already. This will give you ample time to clarify the amount of additional on-site audit time based on know-how, experience and size of your organization, supporting functions on-site or remote) as well as the complexity of processes and existence of a corporate scheme.
TL 9000 R6 Updates
- 5.2. C.1 – Customer relationship development
- 6.4.C.2 – Work area
- 7.1.V.1 – Service delivery plan
- 7.2.2.C1 – Closure tracking
- 7.3.2.S.1 – Identification of software requirement
- 7.5.1.C.1 – Customer service resources
- 7.5.1.S.1 – Replication
- 8.5.1.C.1 – Continual improvement program
- 9.1.3.C.3 – Sustainability assessment: The organization should assess the status of its sustainability efforts as appropriate to its organization, products, and services. QuEST Forum has also provided a sample sustainability assessment model in the TL9000 website (tl9000.org).
- 9.2.2.C.1 – Internal Audit Program Planning: Internal audit program shall include all applicable Requirements and Measurement Handbook requirements. This has been an implicit requirement till now, but this adder made it explicit.
7.3.1.HS.2 – Design and development process quality measurement planning and implementation
7.2.3.HS.2 – Design and development process quality measurements data reporting
8.3.2.HS.3 – Design and development process quality measurement planning and implementation
7.3.2.H.1 – Content of requirements
7.3.2.C.2 – Design and development requirements
8.3.3.C.2 – Design and development requirements
7.5.1.S.1 – Patching procedure
7.5.1.S.2 – Patch documentation
8.5.5.S.1 – Software patching information
8.4.HS.1 – Field performance data
8.4.V.1 – Service performance data
9.1.3.C.2 – Performance data
DQS Now Accredited to Offer RC 14001:2015
RC14001® Technical Specification (2015 edition) was published and released in late 2015 and is now available for companies to be registered to this updated Standard! DQS Inc. is proud to say we have now attained accreditation to offer RC 14001:2015 accredited certificates, effective April 4, 2016. We are one of the first Certification Bodies to be accredited by ANAB for this service.
The new RC 14001:2015 Standard combines elements of the American Chemistry Council’s (ACC) Responsible Care® initiative with those of ISO Standard 14001:2015 “Environmental management systems – Requirements with guidance for use”. The new High-Level-Structure of RC14001:2015 is aligned with other ISO management system Standards for clause numbering and section content and so is highly suitable for integrating management system components.
The ACC is allowing a three-year period for transitioning to the new Standard, from the September 15, 2015 official release date, and so this timing is also aligned with ISO14001:2015 transition timing requirements. DQS Inc. will be providing additional guidelines that include specific information for optimal timing of your transition to the revised Standard. This is important because all organizations are required to be transitioned to the new Standard by September 15, 2018 to retain their certification to RC14001.
There are many benefits of certification to RC14001 and the new 2015 revision. A key benefit is that it provides a company, through an application and audit process, a certification that its management system conforms to both the ISO 14001 and RC14001 requirements.
As in past versions of RC14001, the Technical Specification has two components. The first is the actual text of ISO 14001:2015, which specifies requirements for an environmental management system in support of a sustainable environmental commitment. The second component includes requirements stated within corresponding text-boxed areas. These are the additional Responsible Care elements required under an RC14001 scope.
RC14001 is one option that ACC members and Responsible Care Partners may select to meet their Responsible Care management systems certification requirements. RC14001 is also available to non-ACC organizations that are interested in certifying a comprehensive management system covering the environment, health, safety, security, product stewardship and outreach activities. RC14001 audits are conducted by certification bodies, such as DQS Inc., who are accredited by the ANSI-ASQ National Accreditation Board.
ISO 13485:2016 Update
The long awaited ISO 13485:2016 update is finally here! For the first time since 2003, there is a new revision of the ISO 13485 standard, as of February 25, 2016. This is the 3rd edition of this standard.
Unlike ISO 9001:2015, ISO 13485:2016 has not transitioned to the high level structure. The new version is based on ISO 9001:2008. It has been recommended by the technical committee that there be a three year window from the issuance of the standard to upgrade to the 2016 revision. For most clients on an annual surveillance cycle, that may include at least two Surveillance audits and a Recertification audit to upgrade. Organizations on a biannual audit frequency will have a few more Surveillance audits to make this transition possible.
Considering the release date of the standard, the three year certificate upgrade window will run until February 25, 2019. Any certificate that is not upgraded by that time to comply with the requirements of the 2016 revision will be withdrawn on the effective date of February 25, 2019.
If your ISO 13485 certification also includes ISO 9001, the timing for the upgrade should coincide with the September 2018 requirement for ISO 9001:2015.
Current certifications may be upgraded to ISO 13485:2016 at any time during the registration cycle. It may be done as part of the Recertification audit, regularly scheduled Surveillance audits, or by having a Special audit done at the organization’s preferred time.
DQS Inc. will be planning webinars in the near future to go over the changes in ISO 13485:2016 and integration with ISO 9001:2015. Webinars and updates will provide additional information for the upgrade process and will be coming soon.
We look forward to helping you prepare for your 2016 revisions!
First DQS Inc. Customer ISO 9001:2015 Certified
DQS Inc. is proud to say that we have had our first customer successfully upgrade to ISO 9001:2015. Congratulations to Extron, Inc.! Please see their statement on the upgrade below.
Extron, Inc. is proud and excited to be the first DQS customer to be certified to the new ISO 9001:2015 Standard. This would not have been possible without the effort of all Extron employees and the auditing staff provided by DQS-US.
Extron, Inc. is a leading ISO 13485 & ISO 9001:2015 certified high-tech manufacturer offering solutions designed to improve supply chain cost, flexibility and risk exposure. Extron’s 120,000 sq. ft. facility is located in Milpitas, CA, producing product for Fortune 100 companies in the medical, aerospace, defense, technology, communications, medical, and automotive sectors. Extron provides on-demand product configuration in close proximity to distribution channels, helping its clients reduce manufacturing costs, maintain control of IP, respond faster, and reduce risk. Extron also provides returns management solutions, systems integration services, and is the North American source for Knurr mobile electronics carts, consoles, and custom racks and enclosures. Visit http://www.extroninc.com for details.
Extron’s ISO 9001:2015 certification updates the company’s ISO certification and extends the company’s position as a leader within the high-tech manufacturing industry, as it demonstrates Extron’s high levels of quality management and operational excellence. Across the wide range of industries that Extron supports, the certification inspires confidence in Extron’s ability to consistently meet customer, statutory, and regulatory requirements.
Aspects of the New Standard by DQS Lebanon
We are thrilled to be able to share with you the below article written by Edward Grissom, General Manager at DQS Lebanon. In the article Grissmon shares a conversation he had with one of their customers about transitioning to ISO 9001:2015 and shows the evolving opinion the customers can have about it when they are more informed about how it effects them.
“What happened to ‘Say what you do, and do what you say’? I have a million things to juggle, and I don’t have time to re-work our manual”. This was Jamil’s response to our conversation regarding the new ISO standard 9001:2015. His response is typical among our customers. Jamil is the owner and general manager of a successful family owned SME and aspires to greater growth. He appreciates the benefits that come with ISO certification; however, at times he feels the requirements go
beyond what he really needs. He was not convinced that he would actually benefit from having to update his QMS in order to comply with the new standard.
He listened as I explained the process ISO goes through in order to review and update one of its standards. We discussed market changes worldwide, changes in customer expectations, technological advances, changes in sector specific requirements and new organizational knowledge. Jamil said it was interesting. We further the discussed the process of the review, modification and approval of the new standard—including the amount of time and money invested, the type of experts that participate and the sources of input which comes from varying markets around the world. Jamil was impressed. However, he still was not convinced. His mood did change, however, as we began to discuss some of the details in the actual standard. The real value for him and his company began to become clearer: The new standard provides understanding, tools and vocabulary that moves his decision making process and his company’s control of its work from the intuitive to the analytical.
Jamil did not really understand my explanation of “Understanding the Context of the Organization”, until he realized that he had considered external and internal issues when he took over as General Manager from his father. Office and factory space are found only at a premium in our area. Inevitably, the most practical location for his business is the one that he inherited from his dad. He would have preferred to have rented a new space and built a factory from scratch, but given the company’s history, that was not possible. He said that the company name goes back a long time, and customers feel comfortable knowing that his products and service have a long history. He added
that had he moved to a new space, he also would have faced unwanted issues with his top managers’ commitment to the company. We expanded this discussion to incorporate other internal issues that Jamil had thought relevant, but had never considered such as updating equipment, the role of tradition regarding his brand and the challenge of increasing his work force with younger, more open-minded employees. Suddenly, understanding the context of his understanding by realizing internal issues he had already considered wasn’t so foreign. We experienced the same pattern regarding external issues. Immediately, he began to complain about the political deadlock in our country—there has been no trash service for 3 months. Although, trash is being picked up in his area, the government hasn’t resolved the issue. The government hasn’t appointed a president in
the past year. As a result, government contracts are held up and sometimes payment is slow. His list continued.
As he mentioned his problems with municipalities, we naturally began talking about interested parties. When he has looked over the standard himself, he admitted that he didn’t see any value in making his intertied parties. “I already know them.” Of course, the municipalities would be one, and I know what they want”, he said. However, after considering external issues, a light went on in his thinking. “But, that does make me think about a big problem we have. Invoices.–and not just from the municipalities. Sometimes we have outstanding invoices for months now. Folks are slower to pay, because it is taking time for them to get paid. They pay, but we need to nudge them a little.
Truthfully, sometimes we do the same thing. We have to put payment off for a week or two. Then we kind of forget. We will pay, but other things come up”. He barely finished the sentence when he looked at the QMR in his office, “We really do need a new procedure for tracking and assuring timely payment of invoices. We really didn’t need a strong procedure before. But, honestly, now we do”.
Jamil was beginning to lead part of the conversation now and even laughed when I moved on to Risk Based Thinking. Due to the unsteady security situation, he told me that he had bought an additional phone, and hired a driver to take his kids to school instead of the bus. He just felt safer having more direct contact with his kids on their to and from school. He said and it didn’t really cost that much more, because the bus wasn’t cheap as it is. A result, he started using “Whats App” texting and sending pictures to/from his kids. It was fun. He laughed because he realized he had employed “Risk Based Thinking” in his home. He wondered if there maybe some possible applications regarding the security and invoice situation in his business.
Rather than stop, I did continue on concerning the requirement of employing a process approach, and in particular, the requirement to measure whether these processes are achieving his desired results. Of course, Jamil was familiar with the process approach and did a good job of clarifying for his employees the steps needed for production and contact with customers. So, rather than explain that KPIs were needed for each process, I simply asked him what were the 3 most challenging decisions he had to make last year. Without thinking, he said, “Whether I bring on more drivers for delivery, expand our sales location into a partial production site as well, and whether I should replace one of my site managers. I’m still thinking about them, actually.” As he told me the information he was considering in order to take action of these decisions, it was clear some of the needed input would naturally be part of KPIs for certain processes. He began to appreciate that the value of the KPIs was not just making sure everything was going as planned. But, they also could provide helpful information that lead to smarter and quicker decisions.
We wrapped up our forty-minute meeting. Jamil was now looking forward to the new standard. Jamil had always been convinced that he would go forward with certification to 9001:2015, but now he was convinced that it provided specific advantages for him and his company. He no longer saw the transition from the old standard to the new as one more thing that he had to juggle, but a tool—in fact a strategic decision—to help him juggle all the things that inevitably are thrown his way.
The New ISO 9001:2015 Standard by DQS Malaysia
Following the articles we were able to share with our customers from DQS Argentina and DQS Taiwan, we are now proud to present an article by Soong KV from DQS Malaysia.
Changes of this latest version of ISO 9001 compare to its previous version of year 2008 are significant and accommodate to current management system trends. Previous focus in identifying core processes and ensuring effectiveness of these processes so as to achieve customer satisfaction, are now talking about the assessing and evaluating the risks and also opportunities of key processes in the context of each organization. The organization is now required to determine those interested parties who are relevant to the management system and identify the needs and expectations of these interested parties.
Top management in any organization is always the key factor to drive to success. This new version therefore emphasizes active involvement and participation of top management to ensure effective implementation & maintenance of quality management system. This is clearly described in clause 5 Leadership in the new Standard. Also significant change from previous clause of 5 Management commitment and responsibility, the position of Management representative has been removed from this revised Standard. The roles & responsibilities of MR are now part of clause 5.3 of the revised Standard.
In clause 6 Planning, Risk based thinking or Risk analysis is introduced in year 2015 version. This may not be new for some organizations especially those ISO 13485, ISO/TS 16949, AS 9100, etc. certified organizations who has implemented risk management using FMEA, ISO 14971 etc. tool. But it is definitely a very significant change in the development of ISO 9001:2015. There is no requirement to have a specific tool nor method to determine the risks. However, the organization is expected to demonstrate how the risks and opportunities in all identified processes are analyzed and evaluated. In association with these identified risks and opportunities, the management shall plan relevant actions to address these risks and opportunities as well as how to integrate and implement these actions into the processes and evaluate effectiveness of these actions. As per previous versions, quality objective remains as it is and now the 4W1H approach is introduced to plan the achievement of set quality objectives.
Previous clause of 6.1, 6.2, 6.3, 6.4 & 4.2 are now restructured and rephrased in clause 7 Support. Document and record are now redefined as Documented Information. Clause 7.6 Calibration of 2008 version is now addressed in Clause 7.1.5 Monitoring & Measuring Resources.
Previous clauses of 7.1, 7.2, 7.3, 7.4 & 7.5 are now addressed in Clause 8 Operation. The revision of this 2015 Standard does not allowed any of the requirements/clauses to be excluded. Nevertheless, some of the elements in clause 8 may be not applicable to certain organization business nature.
Clauses 9 & 10 of this revised ISO 9001 are basically clause 8.1, 8.2, 8.3, 8.4 & 5.6 of 2008 version. Management Review is now under clause 9 Performance Evaluation which reflects the nature of this requirement as CHECK activity in PDCA cycle. The review inputs have been expanded to ensure items to measure effectiveness of quality management system, such as achievement of quality objectives, performance of external providers, customer satisfaction & feedback from interested parties etc., will be reviewed effectively.
With all these changes, thorough an in-depth readiness review for our existing certified clients towards smooth transition of ISO 9001:2015 is deemed necessary. Explaining to the client about this onsite readiness review will be a challenge ahead considering other certification bodies are basically reluctant to practice so. Nevertheless, as a preferred certification partner, DQS’s approach towards upgrading to this ISO 9001:2015 shall be valued. This is very much similar to patient and doctor kind of scenario. Doctors will never diagnose nor prescribe “Offsite”. He/she for sure will see the patient face-to-face (“Onsite”) to ensure clear and unambiguous information obtained to support his diagnosis and prescription. Hence DQS’s on-site readiness review for our certified clients towards the transition of revised ISO 9001 serves the same purpose.