Any organization to comply with statuary requirements requires a regulated process for document change control especially the ones that belong to the pharmaceutical and medical device industry. These industries need a strategic approach to manage the changes in the controlled documents to ensure that every change made follows cGMP and relevant regulatory standards.
What are Controlled Documents?
Controlled documents are the ones that must undergo a regulated and defined process for review, approval, distribution, modification, storage, access, and even deletion. In simple words, a controlled document undergoes standardized processes to manage change and compliance.
ISO 9001:2015 also requires organizations to manage controlled documents for the effective functioning of the quality management system.
What is Document Change Control?
Document change control is all about establishing a streamlined process for transmitting critical information between the involved parties.
As per ISO, Document Change Control can be referred to as control on:
- Approval of important documents based on adequacy before issuing them to the relevant parties.
- Review and document updates as and when required. (It may include reapprovals as well)
- Changes and revisions status of the controlled documents.
- Availability of relevant and most recent versions of the documents at the time of use.
- Legibility of the documents for easy identification.
- Distribution of the external documents in the organization especially the one that comes from subcontractors or suppliers.
- Unauthorized use of controlled documents.
However, the control procedures are applicable to documents as well as records. You must be wondering What’s the difference.
Well, documents include Quality manual, Quality procedures, Technical designs and drawings, Presentation, Recipe while records include Training certificates, Audit findings, Feedback questionnaire/survey, Meeting minutes, order receipt, etc.
Some organizations even have the document controllers to classify the specific documents that must be controlled. Their key role is managing the controlled documents using a set of industry best practices and processes.
What Document Change Control Process is Intended for?
Document change control helps organizations to keep consistency, quality, and compliance of the documents in check. A well-established control process helps to reduce the errors in the critical documents and avoid the inconsistent flow of information. This further ensures that the quality quotient of the end-product doesn’t get affected even if the person at duty changes.
Document change control also improves the reliability of a document, ensuring that it has already undergone a regulated process of review and approval. However, you can also prepare a document control checklist to ensure a compliant process.
How to establish a compliant document change control process?
The conventional change control processes may not be effective since the organizations are shifting to digital documentation. The best way to manage the new-age trend of digitized documents is an electronic document and change control management system.
Most of the document change control management solutions are designed to comply with FDA 21 CFR Part 11 quality standards for documentation including Electronic Signatures and comprehensive Audit Trails.
How a Document Change Control Software can help?
Investing in a specialized document change control management software can help you align the controlled document changes and upgrades with the quality objectives through:
- Initiation and Documentation of Change
- Effective Review & Approval of Change
- Notification of Change to the Impacted Users
- Implementation of the Change
- Automatic Creation, Revision, Expiration, and Archival of your Controlled Documents
- Ensuring Regulatory Compliance
When you have a document change control management software in place, you can initiate and document the change requests systematically. It enables you to store every important information about the change request made including the date, type, justification, priority, the owner of the request and much more.
Documenting the details about change requests can serve as an easy reference for the future if the same request is investigated. It can be a source of evidence too to make informed business decisions.
The change request cannot be processed until it is reviewed thoroughly and approved by the management. A change control software can help you perform different types of reviews including management review and analyze those review results before you approve any change request.
Reviewing and approving a change in the controlled documents is a critical function to be performed and requires utmost precision and accuracy that you can ensure with a change management software system.
In addition to documentation, review, and approval of a change request, a change control management software solution also helps you to notify the change to the impacted users. It gives them enough time to identify best practices to implement the document change within the specified time without any hassles.
A software can help you inform all the impacted users at the same time to ensure no harm to the on-going processes and productivity of your team. This makes your team ready for the change and organizes their workflows accordingly.
Keeping your quality teams and processes informed and aligned with the upcoming changes helps to reduce the change implementation cycle time significantly. A document change software also enables you to configure the workflows based on best practices of change implementation.
An effective software helps to track and to manage end-to-end change processes for multiple change requests at a time that cannot be efficiently done through manual practices of change management and implementation.
Version control and archival of the controlled documents is one of the critical functions to be taken care of during the change management process, which may turn tedious with the traditional paper-based management systems. On the other hand, change management and control software can help you manage all the activities including automatic creation, revision control, expiration, and archival of your controlled documents.
A software helps you to ensure that your quality teams refer to the most recent version of the controlled documents by keeping control of revisions.
The advanced document change control solutions are designed to comply with FDA 21 CFR Part 11 quality standards for documentation so that the organizations can leverage the electronic signature and audit trail. This ensures that only validated and verified information is circulated through the organization.
Hence, using software ensures regulatory compliance for your document change control processes.
A powerful change management software solution also gives you greater visibility into your change processes and reinforces benefits like:
- Reducing the time to implement a Change
- Getting Better Understanding of Growing Customer Needs
- Establishing Best Practices to Achieve Business Goals
- Defining Operational Workflows to meet Industry Regulations
- Attaining Excellence in Business Performance
Wouldn’t you like to standardize the change management processes across the organization to improve your product and quality processes?
So, get an effective change management software like Qualityze today. You can test its functionalities for free by requesting a free demo.
The cherry on the top: You will also get the 1-week product trial for free.
“Customer is King” or “Customer is always right” – all these sayings that organizations used to swear by are fading away.
No, this doesn’t imply that you are not serving enough goods and services to your customers. More than the availability of products, it is about fulfilling your customer expectations these days. And, when they are not fulfilled, customers tend to make complaints and sometimes, they simply share their feedback through reviews.
Only when you handle the customers’ complaints effectively, you will be able to build stronger relationships with your customers. Moreover, these complaints, feedback, and reviews may unlock many new improvement opportunities for your business.
Before we move on the components of an effective complaints’ management process, let’s quickly look at the checklist that your complaints process should fulfill:
- It should be customer-focused
- It should offer complete visibility and traceability
- It should be easily accessible
- It should be responsive
- It should be objective and fair
- It should maintain confidentiality
- It should drive appropriate solutions
- It should be properly reviewed
- It should be accountable
- It should drive continuous improvements
To establish the right controls in place according to the checklist mentioned above, you should be aware of the 5 Key Components of the Effective Complaints Management System. Those components are:
- Well-Defined Customer Complaint Policy
- Definition of a complaint.
- All the channels and methods the organization will use to receive complaints.
- A detailed explanation of the complaints handling process including the dependencies on different departments or authorities.
- A clear outline of the factors that make a complaint high on priority.
- Standardized Complaints Management Process
- Are the timelines of the complaint responses specified?
- Have you established a centralized database to store complaints and their respective investigations and resolutions?
- Who will be responsible to record the complaint? Who will be involved in the investigation? Who will review the entire process? and much more.
- Which complaints will go to management?
- Assigning Responsibilities
- Who will be collecting and recording the complaints in the database?
- Once the complaints are reported, who all will get the notification?
- Which type of complaints will be resolved by which department?
- Who will review the resolution of the complaint and approve it?
- Who will notify the details to the top management?
- When exactly a complaint should be escalated and to whom?
- What are the respective timelines based on the complexity of a complaint?
- What could be the consequences of not handling the complaints on time? Etc.
- Training and Development
- Tracking and Reporting
If you take the aspect of complaints management seriously, you must have a well-defined customer complaint policy. The policy must include:
The complaints that fall in the category of high-on-priority can either be a complaint that points any sort of discrimination /violates any legalities or a complaint that could blemish the brand reputation such that the entire bottom line gets affected.
So, you must have a well-defined complaint policy for your organization to ensure that every member of your complaint handling team follows a standardized process. It will help avoid more damage to the image of the brand and your ability to do your business.
Like any other quality management process, the complaints management process should also be aligned in a standardized way to ensure that everyone follows the same processes and procedures to manage customer complaints effectively. Such sort of clarity in processes will help your internal team to be more efficient while limiting the compliance and quality risks in managing complaints.
If you don’t have a streamlined process for complaints management, you are likely to face bigger risks. Makes sure you formulate the complaints process after evaluating all the aspects such as receiving, investigating, and resolving the complaint. You may consider answering the following questions:
These are just a few of many questions that you can ask yourself and your team to establish the standardized complaints management process.
Assigning responsibilities are one of the key factors that contribute to the success of a complaint management process. But this may grow complex with expansion of the organization. If there will be no clarity about the responsibilities, you won’t be able to handle the complaints effectively.
So, whenever you create or review the complaints management process, make sure you have clearly communicated the responsibilities of each team member as to:
These questions depend on the internal structure of your organization. Clearly defining the responsibilities will reduce the chances of missing complaints, which could also hamper the brand image.
Yet another important aspect of a successful complaints management system, training and development needs should be carefully analyzed and evaluated to ensure that the complaints management team responds to customer feedback, complaints, and queries with the most suitable and relevant solution.
Even if the team finds it difficult to respond to a customer complaint, they should know the right time and person to escalate the complaint for timely resolution. And, this all will be possible only when they will be trained for the role and responsibilities assigned to them.
For identifying the right training needs and programs, you can use a training management software since your team’s competency will reflect the organization’s capability to handle the customer complaints.
So, make sure your team is trained enough to handle all the critical complaints professionally while limiting the compliance risks.
Now that you have a complaints management policy and standardized processes to manage policies with defined roles and responsibilities, it comes on analysis and review process to understand whether the processes you have established are working well. It will only be possible if you will have the right tracking and reporting system in place.
With proper tracking and reporting system, you can identify the loopholes in much lesser time and improve your product, processes, and even training programs to make your employees competent.
There are many complaints management software that comes with inbuilt features for tracking and reporting all the important insights of a complaints process such as who made the complaint, when was the complaint made, who handled the complaint, what was the resolution, etc.
The Bottom Line
Complaints handling is the most critical task to ensure customer satisfaction. You must implement advanced complaint management software like Qualityze to address all sorts of customer complaints in a proactive and timely manner. This will help you to keep your brand image preserved while ensuring that no compliance regulations are abandoned.
For more information, get in touch with our customer success team. They will help you establish a compliant-friendly complaints management system and handle the customer complaints more efficiently than ever.
Audit Management Systems are vital for organizations to maintain a culture of continuous improvement while achieving business objectives. There has been a recent upgrade made to the International Standards for Auditing Management Systems to help organizations maintain a competitive edge in the marketplace.
The most recent version released in July announces the guidelines for all the aspects of the audit management systems from the basic principles of audit, audit management program, performing audits and managing the audit findings while setting out the guidelines for evaluation of the competency level for the people involved in the entire audit process.
There is an increased emphasis on risk-based audit processes in the new revision of auditing principles to drive continuous improvement more effectively. The new principles also talk about harmonizing the multiple systems available in a place with a standardized approach for the entire auditing process.
The current revision of the standard demonstrates the increasing number of standards for management systems include the recent revisions of commonly used standards such as ISO 9001 and ISO 14001. However, the new revision is still under the Committee Draft (CD) stage that gives all the countries involved freedom to comment on their opinions for the draft before it finally gets published.
“When the standard was last published in 2011, there were 11 management system standards, but that number has since grown significantly to 39, with 12 others in development.” Says Denise Robitaille, Chair of ISO/PC 302, the ISO project committee responsible for the revision. Reference link
This revision is intended to serve the needs of sector-specific standards for different organizations. Since one can easily find the management standards covering different aspects including environment, services, health and medical, information technology and more, there is a need for robust auditing processes for these systems to reflect the effectiveness of new standards being developed.
ISO 19011 is meant for all the organizations that need to conduct internal or external audits of a quality management systems they are using. It is suitable for a broad range of potential users, including auditors. If you are also implementing quality management system, you will have to conduct audits of management systems for regulatory and compliance purposes.
ISO 19011 also includes the guidelines to conduct the external audits, for certification and supplier quality check, to support the implementation of quality management systems. These guidelines are based on seven basic principles.
Principles of Auditing
The auditing of management systems is based on seven fundamental principles that make an audit management system effective tool to support the quality processes, controls, and policies. It guides the organization with critical information to act upon and improve its overall performance. Following these principles enable auditors to work independently since they can get more relevant audit findings.
The seven principles are briefly explained below:
- Fair Presentation
- Due Professionalism
- No Dependency
- Evidence-Based Approach
- Risk-Based Approach
It is also referred to as the foundation of professionalism for auditors as well as the individuals involved in the audit program. They should perform all their duties with proper ethics, responsibility, and honesty. They should perform the audit activities for which they feel competent. Most importantly, they need to be unbiased in all their dealings and should be influenced while making any final call of judgment.
Auditors need to demonstrate all the audit activities and materials including reports, findings, and conclusions accurately. They should report every major and minor obstacle they experienced during the audit even if it is a difference of opinions between him/her and the audit team. The clear, timely, and truthful communication is the key to the successful auditing of the management system.
Auditors should exercise due care for the tasks they are performing since the audit clients and the other involved parties have shown trust and confidence in them. They should not compromise on professionalism when it comes to making judgments in different audit activities. The more they will exercise due professionalism, the more reasonable judgements they will be able to make.
It might sound very cliché when we talk about the security of information, but it’s quite critical to care for. Auditors should, at not condition, disclose the information related to their duties including the errors and findings they encountered inappropriately for the personal gains. This is applicable to the audit client as well. All the information regarding auditee should be wisely handled as per the clause of confidential information that will remain between only among trusted parties for the safeguard of business.
Auditors need not involve any bias influences or conflicts when it comes to the audit activity. They should maintain the dependency only on the audit findings and conclusions to make a fair report. It is as important for small organizations as large to make a sincere effort to keep no bias and encourage fair audits for fair improvements.
Auditors, to make their audit activity reliable, should make appropriate use of evidence. They should develop that habit of collecting evidence since an audit is conducted on limited resources for a limited time. Keeping the evidences for all the audit activities helps auditors to keep the confidence of audit clients in whatever conclusions they suggest.
Any audit activity should be performed only after considering all the potential risks and opportunities. Such an approach could bring a difference in all the activities from planning till the execution and reporting of events. Auditors can achieve the audit program objectives more efficiently with a risk-based approach since it can bring their focus on new opportunities.
These were just a few updates from the recent version of auditing standards.
The best part is Qualityze Audit Management System can stand the test of time and evolving standards without any difficulties. You can perform all your audit processes efficiently that require an ample amount of time in planning and executing the audit activities such as creating checklists, managing audit findings, and reducing audit cycle time and costs while fostering continuous improvement.
So, if you also want to standardize the audit management system across your organization to make the most of your audit findings, get Qualityze today to streamline your audit processes cycle the smart way!
Every organization possesses a different culture, but most of them face challenges to implement and maintain a culture of quality. This is generally due to various internal and external factors including improper process management and environmental factors respectively.
However, internal factors can be managed using a robust Enterprise Quality Management System. The real challenge is managing external factors and aligning them with your business objectives.
Why it is important to consider External Factors?
The external factors like politics, competitors, economy, customers, and weather are beyond your control but can make a huge impact on your organization’s performance and success. On the other hand, internal factors like processes, staff, culture, and financial situation can be controlled by you.
You need to understand that external factors are equally important for the stability and profitability of your company. Though you cannot control such factors or changes in them, you can establish a flexible environment to manage the unforeseen market challenges. Such a proactive approach could mean a world of difference for your organization’s productivity.
For example – If the government introduces a new taxation scheme, every company will need competent staff, new procedures, and make some changes to existing processes. The slow response to the scheme could mean a lot of challenges in the change management and potential penalties from the government for respective delays.
Major External Factors and Their Impact on Quality Management
Political Factors: These include the government actions or approaches that can influence the economy, which eventually will impact the way organizations operate regardless of the industry they belong to. This includes political stability, government policies, public investments, tax policies, local infrastructure, and national as well as international trade agreements.
Economic Factors: The economic conditions like changes in the ratio of demand and supply may directly impact organizational effectiveness and efficiency. The economic factors include inflation, changes in the exchange rate, economic growth/decline, and changes in interest rates.
Market Factors: The ever-changing market environment that reflects customer preferences. This may include competition, emerging trends, supply chain relationships, population analytics, customer needs, and demographics.
Technological Factors: It includes the impact of technological advancements and innovations evolving in the market. The most common examples here are automation, new equipment, technology awareness, etc.
Environmental Factors: It majorly covers the environmental aspects that impact the organization’s processes and customer demands. The examples here could be the change in weather, CSR initiatives, and much more.
Compliance and Regulatory Factors: It includes the changes due to the compliance standards and their latest revisions.
Every external factor is responsible to bring some change for the entire organization and all the changes need to be managed effectively and efficiently to transform the unfavorable conditions into improvement opportunities.
The question is – how to manage change in a better and improved way?
Next, you will get to know some fail-proof strategies for successful change implementation and management to make the most of your quality efforts within the specified time.
Those critical strategies are:
- Learn the Change Management Process
- Identify the key goals of initiating a change
- Establish a team to manage the process of change
- Communicate well with the affected members
- Conduct an effectiveness review
- Identify and implement the required training programs
- Get hold of Project Management Skills
- Implement Right Training Programs for Employees
Organizations need to have a streamlined change management process just like any other quality initiative they make. They may need to consider numerous factors including the culture, the work environment, work performed by their staff, and the quality initiatives already implemented in the organization.
The most important factor that can impact quality initiatives as well as the change management process is ever-changing customer needs. This is why; it is important for the quality professionals to understand the change management process thoroughly.
Here are some important steps that can help you manage change effectively:
Quality initiatives that foster change are no less than a project since a change requires efforts from different people belonging to different departments, who are not otherwise connected. At times, when change is initiated through some third-party vendors. There can be some differences in the approach and working methodologies. Such differences could lead to Increased costs of quality, delays to market, and most importantly, customer dissatisfaction.
Any change process should have measurable outcomes that will reflect the effectiveness of measures and action plans implemented.
The change and quality initiatives, as we already discussed, are opportunities for quality personnel. They need to enough relevant skills and knowledge to manage every quality initiative excellently. Only then, they will be able to ensure that they are completing the given projects within the specified time, costs, and available resources.
In the early 1990s, the trend of training risen unexpectedly well because the quality management was gaining traction. Without training, all new initiatives cannot be managed properly.
However, the new trends quickly became the standards. The evolutions occurred, many new paths were identified, and so much happened with over time. In the fast-paced evolutions, some of the principles seem lost. The organizations, in some or the other way, started losing customer focus, a thorough understanding of change, cultural differences. It is high time now that organizations should implement the relevant training programs to shift focus to the critical things again.
The modern-day organizations desperately need to go back to the basics and ensure that the quality professionals involved in the change initiatives are trained with the relevant skills. This will make the employees more competent while improving the organizational effectiveness to another level.
The Bottom Line
Getting a thorough understanding of the change management and implementation process, it will become easy for every organization to face the impact of external factors on their quality management system and processes. However, the robust change management system software like Qualityze can lower the degree of complexity in change management.
This will further allow quality professionals to improve organizational productivity and effectiveness with the relevant quality initiatives.
Quality Improvement is one of the challenging and complex aspects for the healthcare industry that focusses on improving the patient experience since they need to align the industry changes with the different levels and processes of their organization. The best way to deal with such challenges is to leverage the established Quality Improvement approaches with improved technologies.
Quality improvement in healthcare is all about increasing efficiency, efficacy, and safety utilizing best-practices and methodologies. Hence, both qualitative and quantitative improvement has become critical in healthcare. The improvements will further lower the quality costs while allowing access to next-generation technology.
Impact of Quality Improvements on Healthcare Performance
Quality improvements have a direct relationship with healthcare performance. More and effective will be the quality improvements; higher will be the level of performance. The healthcare organizations that will continue with the traditional methods and approaches cannot expect any enhancements to the performance.
Quality improvements offer healthcare organizations an opportunity to replace inefficient systems and focus on more worthy things. For example – switching to digital records for patient health analysis. You can also use the software for record-keeping. For healthcare manufacturers, there are quality management software systems that allow them to manage product and process quality and mitigate quality issues by using standardization and industry best practices.
Benefits of Healthcare Quality Improvement
When we talk about healthcare quality improvements, we cannot ignore the following benefits:
- Enhanced visibility and readability of a patient’s health records.
- Store the medical history of the patient on a single platform using EHR.
- Generating better results.
- Reduced new healthcare initiatives time.
- Ensures expert consultation and analytics when required.
Hence, quality improvements in healthcare improve the quality of health services while keeping the costs minimum.
The objective of Quality Improvements in Healthcare
Quality improvements help healthcare organizations to achieve six main objectives including:
- Safety: Quality improvements, especially those led by technology, help healthcare organizations to provide the right healthcare to patients that can help them without any harm. But before upgrading to next-generation quality improvement approaches, they should be guided properly with the respective information to make efforts in the right direction.
- Effectiveness: The healthcare industry couldn’t afford risky improvements. They want services that can benefit them and the patients. They strictly refrain from the services that aren’t likely to be of any benefit or significant improvement in the care intended for people.
- Person-Centered Care: In healthcare, patient-centered care has changed to person-centric care. They need the advanced quality management systems that can help them serve individual preferences, coordinate and integrate care properly, inform and educate patients, physical comfort, emotional needs, involve family and friends, maintain continuity and smooth transition, and personalized access to care. This helps to align patient care with all clinical decisions.
- Timeliness: The appropriate quality improvements may help reduce the process delays, which sometimes become harmful for both the parties involved i.e. the one receiving the healthcare and the ones who are responsible to provide care.
- Efficiency: Efficiency in healthcare implies lesser waste – be it of equipment, medical supplies, ideas, and even energy. There is a need for quality improvements that can make processes efficient, keeping the product and efforts wastage to a minimum.
- Equitability: Healthcare should be provided without any biases on gender, socioeconomic status, ethnicity, and geographical location. Quality improvements should be introduced keeping the same into consideration.
Now that you understood what objectives that the healthcare quality improvements help meeting, it’s not sensible to question the credibility of improvements.
5 Key Components of Quality Improvement Programs
Every successful quality improvement program is based on the five key components. They are:
- The problem,
- The goal,
- The aim,
- The measures, and
- The Analytics
No successful quality improvement will ever start without having a problem to resolve. A deeper understanding of the issue will help you to choose the right quality improvement initiative, which can effectively resolve the problem it is targeting. However, you can list every other thing as a problem. Be sure to list the problems that are concerned with quality care for the patients.
Identifying the goal that you want to achieve with quality improvement initiatives can be a challenging task for almost every healthcare institution. The reason is that every quality improvement has certain benefits associated that will be tempting at once. The right approach here will be that healthcare leaders perform a detailed analysis of target improvements concerning returns on investment and cost-effectiveness. There are certain questions that healthcare leader may ask their teams onboard to define the right quality improvement goals:
- Do the quality improvements align with the organizational improvement objectives? And, How?
- What are the biggest risks for patients with improvements?
- What volumes of variations the quality improvements could result in?
- How the entire improvement process will impact the cost-effectiveness?
- How will the effectiveness be measured for the improvements done?
There could be many more questions based on the objectives and stakeholders’ concerns with the significant quality improvements to decide the final goal to be met.
Determining the aims for different processes will help healthcare institutions to manage the goal achievement work into multiple manageable blocks. Each block can be handled by different people. It will help to attain the goal in a lesser amount of time and costs.
Whenever a quality improvement initiative is taken by healthcare institutions, there could be two scenarios – one with the results and one with the improvement. Understanding this difference is critical. You need to understand the baselines and actuals. This gives the healthcare systems a clarity when they are actually making improvements to the existing processes and when they are just intervening.
Analytics plays a key role in bringing out the clear insights in the highly confusing world of healthcare quality improvements. It allows easy assessment of care quality, care costs, patient experience, and most importantly the effectiveness of the improvements done so far. Right analytics help healthcare units to validate the measurements with smooth data sharing.
It won’t be wrong to conclude that quality improvements are powerful enough to transform healthcare and its functioning.
The Bottom Line
Though it’s not easy for healthcare institutions to cope and grow with the speed of quality improvements, it’s very critical for them to identify the right direction that can help them achieve the strategic improvement goals. The improvements help them become more manageable to achieve the desired outcome.
Since all the healthcare professionals have one aim to choose healthcare that they want to provide people the quality care. They truly are concerned about the improvements to every patient’s health and experiences. They even want to make it more affordable. But at the same time, it is important to keep the primary goal in mind. We all should make sure that every single quality improvement is aligned with the health improvement of people while reducing healthcare costs and improving the experience.
Therefore, choose the powerful quality management system like Qualityze eQMS Suite to attain the ultimate goal of quality improvements in healthcare in a streamlined, standardized, and compliant manner. Based on the most powerful and secure cloud platform i.e. Salesforce, Qualityze also ensures great flexibility, scalability, reliability, and safety.
Before winning the confidence of your customers, it is very important to win the confidence of your employees that the information they are referring to is accurate, appropriate, and adheres to regulatory standards. If they will not be sure about the basics, it won’t be possible for them to deliver the expected quality.
Though customer satisfaction is the key objective of any business, it cannot be achieved without employee engagement and satisfaction. Make sure you have the right document control and management system in place to provide your employees with all the required information to perform their job efficiently.
Having an appropriate document control system is ensuring the best practice to manage all the important business information and documents. Document control often reduces the errors in the documentation since it helps to create a streamlined process for reviewing the documents.
3 Important Reasons to Have Document Control
Any business requires appropriate and accurate information and documentation for an efficient decision-making process. It gives all the management people and stakeholders access to the organized documents, following which they can take a proactive approach to the business improvements. The top 3 reasons you should have document control are:
- It makes your quality data searchable by keeping it properly indexed.
- It reduces the errors and omissions in the documentation by setting up a formalized review process.
- It eases the document management by automating various tasks including templates creation for capturing information.
How does Software Help with Document Control?
Due to the efficiency that technology has gifted to our day-to-day functions including document management, most of the people are transferring to the electronic document management system from the traditional paper-based systems.
With the new and advanced software available for managing the critical documentation part, businesses have found an efficient and productive way to achieve operational excellence.
There are multiple ways in which electronic document management and control software can help you to process and manage critical business information documents. Some of them are listed below:
The software can help keep document revisions managed with version control
You cannot expect any document produced by a team member the final version. It goes through reviews from the other team members. Until there is one copy finalized to be published, you will have so many revisions of the same document. And, manually it is difficult to track them all. You need a good document management software that can help you track all the changes and store all the document versions at one place for quick and easy retrieval. The software also helps you track the details of the changes made and by whom they are made. Isn’t relying on a smart document management software a good idea? What do you say?
The software can help to automate document approval/review process
We all will agree that sharing the documents, getting them reviewed, and their final approvals are tedious and time-consuming tasks if performed manually. On the other, a document management and control software especially the cloud-driven software makes it easy for you to share the critical documents among your network easily and simultaneously. A cloud-driven document management system also provides you a centralized platform to collaborate with your team and perform a collective review process. You can also schedule the approvals and reviews well-in-advance, unlike paper-based systems.
The software can help to keep all the document records traceable
A manual document management system may not be effective and efficient in tracking details about all the documents stored, but an electronic document management system can help you access all the relevant details in a few minutes. Document tracking can be done within the matter of few clicks and you will get to know who the owner of the document is, who is responsible for the review, who will approve, etc. If you are concerned about the traceability of the documents, the software is the most efficient help you can get.
The software help to automate the document archival/obsoleting
In addition to increased traceability, you can also control the archival and obsoleting activities through advanced document management software. The manual process will require ample storage space to archive the documents and you will end up wasting a lot of paper when you will destroy the documents you don’t need anymore. So, it’s sensible to switch to the EDMS that not only saves you extra efforts of arranging folders and destroying records, but it also helps you schedule the archival and obsoletion for a document after its intended use.
The software help you create secure space for the regulated documents
We all will agree that a software renders us a secure place to keep all the regulated documents including SOPs, Policies, etc. safely. With the admin rights given, you can ensure safety for your business-critical documents that cannot be expected in the manual documents. An electronic document need not suffer any natural wear and tear unlike paper-based files unless you delete the document from the system permanently. Would you still risk your important information when you can keep it safe on the software?
The software help you control documents with access rights
This is quite a real deal. You just cannot save your documents from the unauthorized people in the manual systems regardless of how hard you try. Intentionally or unintentionally, your paper-based files are always vulnerable to unauthorized access. This could lead to serious business issues including the leak of important information or credentials. But, you can completely forget about this issue with an electronic document management and control system like Qualityze that allows you to control document safety with access rights. You can make the document accessible only to the authorized people that too with different rights for reading, editing, sharing, and deleting. Isn’t that actual document control you are looking for?
The software help to establish effective communication for document changes/modifications
An EDMS especially the cloud-based systems offer you and your team a centralized platform to collaborate and communicate on the changes or upgrades required for a particular document. This will save everyone’s time and also to avoid any sort of delays with document processing and release. Make sure you invest in a cloud-based document management system to stand the test of time wherein you need to upgrade with the ever-changing technological environments.
Hope all the benefits discussed above have given you a clear demonstration on How an EDMS can help you with the document control and management since it is the key for successful quality management process and system.
Hence, choose the right EDMS software for your business requirements to keep the important documents and information securely accessible. Such a proactive and organized approach will help you to win any auditor’s confidence in your business and attain all your key objectives.
Right Electronic Document Management Software to Rely On
Undoubtedly, there are multiple options to choose on the web when you lookout for the best document management software online. This makes the selection of the right software a bit tricky and time-consuming.
In this post, you will get the resolution for that problem too. You need not crawl through different websites or do any comparison to find the right EDMS solution for your business. The best solution to help you with the document control and management is Qualityze Document Management Solution. It is listed among top 10 document management solutions in many reputed and reliable sources including SoftwareWorld.
Do you want to streamline the document control and management process in a matter of few clicks? Qualityze EDMS is the best pick!
For manufacturers, it is quite common to encounter quality issues in products and services repeatedly. This may result in numerous problems. Some of them can be directly reported by customers while some may be identified by an internal audit team. In any case, quality issues may hamper the brand reputation and customer loyalty.
That’s the reason; the method of 8 disciplines was introduced to manage the quality issues by addressing their root cause and preventing the recurrence.
What Exactly is an 8D Problem-Solving Method?
8D is commonly referred to as “8 Disciplines” or “8 Critical Steps” for solving quality problems. It is a team-oriented method of managing quality issues, which is highly disciplined and effective. Based on the teamwork, this method offers stepwise guidelines to identify the root cause, define and implement the segregation actions, and finally develop and implement CAPA to mitigate the problem lastingly.
Benefits of Implementing 8D Problem-Solving Approach
8 Disciplines are an effective approach especially for manufacturers regardless of the industry they serve. It drives multiple benefits such as:
- Identification of real factors that led to the problem.
- Address the potential causes that could result in an undesirable situation or challenge.
- Allowing the team to perform a detailed analysis before making any conclusions.
- Preventing the recurrences of similar product and process quality issues.
Steps Involved in 8 Disciplines of Problem Solving for Improved Product Quality
D1: Team Building
You should create a separate team to resolve the quality issues and improve the overall implementation process. All the team members should be competent enough in terms of skills and knowledge to perform the duty assigned. In addition to the competency of the team, it is very important to understand the number of members required to efficiently manage the quality issues.
D2: Stating the Problem
Make sure you state all the details of a particular problem clearly and thoroughly to validate and verify the problem from all the possible resources including who, when, where, etc. It is also called the 5W2H methodology. It includes all the details like:
- (W)ho reported the problem?
- (W)hat is the actual problem?
- (W)hen exactly the problem started?
- (W)here it happened?
- (W)hy it is happening? (Complete Explanation Required)
- (H)ow often the problem has occurred? (To Understand the Pattern)
- (H)ow much quantity of products is affected?
Hence, stating the problem simply won’t work. You will have to describe it for creating and implementing an appropriate action plan.
D3: Define the Interim Containment Action
Once you have tracked all the details of the problem occurred, you need to identify the appropriate containment measures to prevent the problem from becoming continued adversity. The focus should be on the main issue rather than the symptoms. You can discontinue production, in case of defective products, to prevent any harm to customers.
D4: Determine the Root Cause
Kickstart the process by listing all the potential causes to determine the root cause of the problem. You can test and check every probability to identify the actual cause of the problem. Then, you can proceed to define the relevant corrective actions. The most commonly used method is 5M1E. These 6 elements are reevaluated every time a disturbance in the product quality is observed. The six elements are Man, Machine, Material, Method, Measurement, and Environment.
However, you can use multiple tools in the process of identifying the root cause of the problem. Some of the commonly used tools are Pareto Charts, Affinity Diagram, Brainstorming Session, 5-Whys Process, Fishbone Diagram, Fault Tree Analysis, Statistical Analysis, ANOVA, DOE, Regression Analysis, Hypothesis Testing, GR&R, Flow Charts, Audits, and FMEA.
D5: Define the Permanent Corrective Actions
Define the scope of improvements with a list of all the possible solutions. You must remember it is not about mitigating the issues for once; it is about implement the corrective actions that can resolve the issue permanently. You must focus on long-term corrective measures to avoid recurrences and other respective problems. Moreover, you should verify the improvements done if they are effective enough.
D6: Resolve the Issue and Perform Effectiveness Review
Once you have implemented the 5th Discipline and eliminated the root cause of the problem, verify the result. It will help you understand the effects of the solution implemented on the production processes. Remember that the effectiveness review is not a one-time activity; it should be an ongoing process to drive continuous improvement.
D7: Prevent the Recurrence and Standardize the Processes
The problem once resolved shouldn’t occur again and you have to ensure that in the Discipline 7. For this, you need to standardize all the processes, systems, and procedures. You can use a quality management software system to do standardization right. This will further help you to identify the changes required at every level or stage and maintain the continuous improvement cycle.
D8: Appreciate your Team
If all the disciplines are followed and implemented rigorously and you have noticed improvements, it’s time to appreciate your team for their sincere efforts. Also, plan the future activities in orientation with continual improvement to improve your business bottom line. Keeping your team involved makes them feel an important part of the process and they are likely to contribute best efforts.
Truth be told, the 8D process is quite an effective method than all other problem-solving methods. Implemented appropriately, all the process and problem-related quality issues can be easily implemented.[Bonus Tip: Don’t keep appreciation discipline limited to say thanks to your team. Communicate with them openly to understand their needs whether they need any training or any other assistance to match the competency required to perform the jobs and duties assigned. It may work as a permanent corrective action as well.
You can also implement a training management system to manage their training needs effectively and efficiently. It is preferable to go for a cloud-based training software like Qualityze that offers them a flexible way of learning new skills regardless of the geographical locations they are placed at.]
Besides all the important steps we have discussed above, you should know three important things about the 8D process and report that will be of great help in the long term.
- The 8D report is not for your customers. It is just for you to identify the root cause of a problem, resolve the same, and prevent the recurrence. Customers will evaluate everything with the quality delivered to them. However, you can keep and maintain the records to prove that you hear the customer complaints and concerns seriously and addressed them at earliest. It works as evidence for FDA visits.
- Implementing the 8D problem-solving approach is possible when the organization’s top management encourages it with complete authorization and commitment. On the other hand, the involvement of all other team members is equally important. Make sure you have established standardized quality management systems, processes, and procedures to bring the entire organization together to meet the business quality objectives.
- Always prepare a valid 8D report since it will help you improve the product quality and build more customer confidence in your brand. It is key to achieve customer satisfaction. Hence, record the entire process step-by-step to make most of the results you get.
Hope this post has helped you understand the benefits of implementing the 8D problem-solving process for your business. You can automate and standardize this approach using Qualityze Enterprise Quality Management Suite.
If you want to know how our software can help, get in touch with our customer success team at firstname.lastname@example.org or call us on 1-877-207-8616.
Having a well-structured and organized corrective action and preventive action system is vital for any organization to support its improvement activities while meeting compliance and quality requirements. But, it’s no less than a challenge to establish a compliant CAPA system and process especially for highly regulated industries including Lifesciences.
A CAPA management system strengthens your quality management strategy to ensure that none of the quality issues get repeated.
Let’s quickly look through the definition of CAPA
A Corrective Action Preventive Action system refers to the process of investigating and resolving the root cause of the identified nonconformances. The main objective of the CAPA is to prevent the recurrence of a similar problem in the near future. It is applicable for every industry including lifesciences, manufacturing, healthcare, nutraceuticals, etc.
CAPA is a combination of two different terms i.e. Corrective Action and Preventive Action. The basic difference between these terms is Corrective Action is applicable for the problems already occurred whereas Preventive Actions applies to the potential causes of the problem.
An effective CAPA system not only helps to limit the problem occurrences recurrently, but it also helps you to study the trends of such occurrences to make informed decisions. This is the reason, CAPA is referred to as a significant component for a successful quality system that can effectively address the nonconformances.
Planning and Implementing a Corrective Action Preventive Action System revolves around Deming cycle i.e. Plan, Do, Check, Act.
The effective process starts with the planning. If you want to establish a successful CAPA system, you must plan the resources and various other requirements you might need in the process. Preparing a plan beforehand helps you understand exactly how you should proceed.
All the requirements should be rigorously assessed so to avoid repetition of steps or performing an unnecessary step. Executing the planning step right ensures that you have a direction to follow in order to achieve your business goals.
Planning should include duties that need to be assigned to different team members for successful CAPA implementation until its completion. For example – identifying the valid nonconformances, defining the action plan, implementing it, verifying the effectiveness, and many other tasks that are generally performed under a CAPA system to manage the quality issues with accuracy and efficiency without any impact on the ongoing processes.
This is commonly referred to as the development and implementation step wherein all the planned activities get conducted. The primary process in this step is to formally document the policies, procedures, work instructions, SOPs, etc. that are mutually decided and assigned. The documentation is critical to establish a compliant process and system.
The next process of this step is to start implementing the things as documented. It might require you to provide training to your employees. It will make them even more competent for the job and responsibilities assigned. The training can be provided through online programs, on-job practice sessions, or team meetings as suitable.
For example – if you are going to have an electronic audit management solution, you will need to provide training to your employees – how it works and can be integrated with the existing resources.
Post training, the actual implementation should take place so that your employees can use the new skills and knowledge they gained in the training and demo sessions. Implementation brings the new system in function so that your team can manage the day-to-day CAPA operations effectively and flawlessly, unlike the time-consuming manual processes. So, are you ready to streamline your CAPA system with a smart mechanism?
In this step, you can evaluate and assess the effectiveness of the corrective action and preventive action system you have implemented in your organization. It helps you identify the improvements as well as impact soon after the implementation so that you can realize what’s working for your organization? And what’s not?
The effectiveness check step also enables you to check whether all the compliance and industry standards are duly followed. Most importantly, you need to ask why at every step. It will help you understand the newer improvements so as to drive the culture of continuous improvement in the organization.
You must remember to keep the process iterative so that you don’t miss any improvement, which can help your organization attain business operational excellence within minimum costs of quality.
Therefore, the effective review (check) process is mandatory for introducing more improvements to the process that will help to maintain continuity and sustainability.
No real-world plan can be flawless as they say, “To err is human”. This step is a guide to help you manage the glitches, loopholes, or technical issues that you identified in the effectiveness review step by implementing the right action plan.
Since the objective is to ensure continuous improvement, you must design your CAPA system around Deming cycle of Plan, Do, Act, Check.
Setting up such a process manually will be daunting and time-consuming. The best solution here is Qualityze CAPA Management Solution that enables you to perform all the four steps while meeting the compliance and regulatory standards.
With Qualityze, all your CAPA activities including verification and validation of the quality issues identified, investigation of the root cause, implementation of right corrective and preventive action, and documentation of the problems, potential risks, and relevant solutions is as easy as few clicks.
Through its intuitive and configurable interface, Qualityze CAPA management software helps streamline, standardize, and automate the implementation of CAPA process across your organization, while analytics and reporting tools contribute to continuous improvements by offering detailed data, trends, and insights.
To Sum Up
CAPA system is essential for any organization that relies on an objective of continuous improvement. Make sure you establish an effective one with Qualityze CAPA Management Solution to prevent the recurrence of the quality issues once identified and resolved.
If you’re seriously interested to make your quality management and CAPA management processes compliant, you must think of getting Qualityze today!
Delivering quality is the most important business objective for any manufacturing firm. If you have a great product but fail to maintain consistent quality, you are likely to lose success to your competitors’ hand.
Any business must value quality over quantity. This is the only best way to communicate with your customers and build lasting relationships with them. Also, a business’s performance and sustainability depend on the quality they deliver.
Even though quality wins, many businesses still think it is the volume of products they deliver that works for their success. This is often due to the short-term success that makes them unable to notice the harm they are making to the business for the long term.
Quality has become such a debatable topic for the manufacturing industry due to its significance in two important aspects – Product and Process.
Product Quality and Process Quality are the two sides of a coin. Both have an equal contribution in achieving customer satisfaction.
Process quality is all about ensuring proper and compliant processes to be followed for delivering a quality product. The processes should be streamlined and effective enough to ensure:
- Right processes are followed
- All the machinery and equipment are functioning well
- There is a backup plan for any damage occurrence
- All the inventory and stock are in check
- Variability ratio is not high.
Emphasizing on process quality has resulted in tremendous improvements like minimum product recalls. Many of the companies have already started the transformation with Industry 4.0. The investment in analytics and robotics has helped them improve organizational productivity and processes. Moreover, there is a dramatic decrease in costs of quality. Such an increased focus on process quality is totally worth for the quality milestones that manufacturing industry has achieved.
Product quality is all about delivering the conforming product that can serve its intended use. Any quality issue may be classified as the product quality issue since it will affect the functionality. For example, if there is a design error, it will ultimately lead to product failure. However, the cost of product quality issues is always higher than the process of quality issues.
And the real trouble is identifying the quality issues that need urgent attention. This can be done only with the help of a robust Enterprise Quality Management Solution like Qualityze that enables you to establish a compliant process of quality assurance while ensuring continual improvement. The biggest advantage is that you will be able to resolve product quality issues before it reaches to the customers and harms your brand image.
Benefits of Maintaining Product and Process Quality
Maintaining product and process quality could bring numerous benefits for the growth of your business and reduced operational risks. Some of the benefits include:
Building and keeping Brand Reputation Online
Since this is a digital arena, you need to maintain the brand image online. This internet-connected world has given your customers a superpower to make or break your brand with their reviews or feedback. If there is some negative customer experience, it spreads like fire. And, nobody wants that. Right?
You must make serious efforts to maintain your brand reputation online through regular engagement with your customers. You can also invest in a customer complaints management system for efficient and effective tracking and resolution of the quality issues your customers might have experienced.
It doesn’t really matter that you receive a good or bad review, what matters is how you handle it. Regular attention and response to your customers’ words may help you become trustworthy and a brand that cares for their customers.
Lasting Customer Relationships
Keeping customers satisfied is the critical aspect for building customer relationships that last. Delivering quality will increase brand loyalty in your customers so they will keep coming back. This will further lead to increased sales and revenue for an improved bottom line.
Additionally, the repeat customers will become a good source of marketing for your business as their reviews and recommendations will make way for new customers. This strategy works for every business if followed and practiced regularly. Valuing your customers can do wonders to become a trustworthy brand.
You must implement a quality management system to ensure continuous improvement in the product as well as process quality. It will help you maintain the consistency of repeat customers, new customers and a significant increase in revenue.
Gaining Competitive Edge
Gaining competitive edge doesn’t depend on one-time activities, it requires recurring efforts. You have to go the extra mile for continuous improvements. This doesn’t only boost brand loyalty, but also convey customers that they are investing the best quality. And, customers do appreciate such brand efforts for quality improvements.
By continuously striving for standards and best quality, you can also stand out from the crowd with your unique identity in the industry. The old saying “The Early Bird Gets the Worm” is a perfect fit for the industry leaders who innovate and set an example for others.
If you want to gain a competitive edge too, invest your time in identifying the new ways that upon implementation can make a value proposition. This will enhance your brand image too.
Learning from your own Mistakes
Every business strategy doesn’t work as expected. We may tend to miss certain aspects that often lead to failure. Such mistakes should not restrict you from doing something new. Besides, you should take away the learning for an improved strategy for the next time.
This is not applicable for mistakes only. Even if something works good for your business, you should learn from the aspects that made your strategy successful. Whether it’s good or bad, every result carries some learning for you.
Though we are all afraid of mistakes especially the ones that make us experience a downturn, we tend to come up with a solid plan to manage similar incidences in the near future. And, that’s something great about learnings. If you are ready to improve, you should be ready for learnings as well.
All these benefits demonstrate why quality matters for both aspects of manufacturing: Process and Product. However, ensuring quality and continuous improvements would be possible only when you have a powerful Enterprise Quality Management Suite like Qualityze in place.
Qualityze is a suite of 8 robust components including Non-Conformance, CAPA, Document, Change, Training, Supplier Quality, And Complaints Management Solution that enables you to establish a closed-loop quality management system for improved quality and reduced operational risks.
So, manufacturers, take the lead for quality improvements in your process’s and product’s quality before your competitors and become the trend-setter.
Maintaining supplier relationships has become more critical than ever. Though an organization depends on suppliers for the production, it doesn’t mean that all the flaws in the supplier processes should be ignored. There should be stringent processes to manage supplier quality while fostering a culture of continuous improvement for mutual benefit.
One of the best ways to ensure supplier quality is by conducting regular audits.
How Do Auditing Suppliers Help?
It’s not the supplier who pays the cost of poor quality delivered to the customer, it’s you and your brand. Moreover, the loss is not limited to money. It may spoil the reputation since a negative review catches attention more than a positive one.
Conducting regular audits may help you prevent such incidences. There are some more benefits of conducting audits on a regular basis including:
Cost savings is the one to top the list of benefits since every manufacturer looks forward to reducing the cost of quality. It can only happen when you lower the risks and product rework. And, audits are the best way to mitigate operational risks and recalls.
Auditing helps you ensure that your suppliers are complying to SLAs, taking appropriate corrective and preventive actions against recurring problems, and making a proactive approach for potential issues to save time and costs in the future.
Keep your audit management system and supplier quality management system in synchronization to avoid any unnecessary overhead expenses due to supplier mistakes or failures.
Having a robust audit management system helps you ensure that all your suppliers are following regulatory standards since every supplier who promises the quality may not practice it in real. Auditing helps you understand the actual proposition of what they say and what they deliver.
Regulatory standards are getting stringent of all the time considering the customers’ demand for quality. This is why; it has become even more important to audit your suppliers based on the changes introduced. Regular audits help to ensure that your organization believes in standardization.
Hence, if a particular component is defined with weight and power dimensions to fit in a product, it should be followed precisely without any assumptions to avoid any quality issues.
If you don’t follow a regular auditing process, you won’t be able to know that you are receiving the products with consistent quality without compromising the industry standards. This also weakens your vision towards continuous improvement.
You must have a supplier quality management system that allows you to keep a check on supplier’s performance as per industry best practices and maintain the continuous quality improvement cycle.
Auditing also helps you to strengthen your relationship with your suppliers. You can also get amazing opportunities for better partnerships that may offer you fair price and knowledge-sharing.
Now that you know the benefits you can leverage by auditing your supplier performance, you must take a step forward to integrate a robust supplier quality management solution in your quality management system.
With every process so streamlined, you can avoid many cost-extensive experiences including production downtime, delays to market, and most importantly failing customer expectations.
However, implementing audit processes brings along one more responsibility for you i.e. audit follow-up. You can use an advanced audit management solution lie Qualityze to help you with end-to-end audit lifecycle from planning till execution and follow-up. Such software also enables you to schedule the audits and their follow-ups in advance to ensure consistency of processes even if you are not physically available.
Investing in an advanced solution may sound like a huge investment, but this will surely be the one-time investment that will boost your organizational productivity and efficiency.
Features to Look for in a Supplier Quality Management System
Here are some features that you should look for while investing in a supplier quality management solution to complement your quality management system:
- Centralized Supplier Database
To track all your quality supplier records in a validated system with a detailed audit trail for a regulatory environment.
- Supplier Risk Assessment
To assess the risks associated with a supplier for better decision making when it comes to supplier selection. It is calculated based on active parts in the supplier profile.
- Electronic or Digital Signature
To include an electronic signature for every action and decisions performed. It generally includes the name of the signatory, the date and time of signature execution.
- Outlook Email Approval
To enable the approver to approve the application without having to sign in. He/she can simply reply with words like ‘APPROVE’, ‘APPROVED’, ‘REJECT’, or ‘REJECTED’, as a response.
To record supplier life cycle. Every Supplier record has a timeline of an event which tells the user what happened when. In other words, a very high-level audit trail that allows the user to quickly understand the sequence of activities that occurred in the life cycle of a supplier record.
Always remember a quality product starts at selecting the right suppliers as they play a vital role in bringing your product to market. In today’s dynamic and competitive global marketplace, having an effective supplier management process that identifies suppliers that can help you to meet your quality standards is a critical strategic necessity.
Additionally, your supplier quality management solution should enable you to:
- Track and Manage Supplier Qualification Process
- Maintain Supplier Records
- Manage Approved Supplier List (ASL)
- Prepare and Share Scorecard
Bottom Line : You must not ignore supplier audits!
Supplier audits can help you identify many improvement opportunities for your organization. It helps you maintain the reputation, win new customers, and ultimately take your business revenue to a level higher. Make sure you regularly perform the supplier audits to ensure compliance while monitoring the supplier performance. You will tend to receive excellent support from the suppliers associated with you.
One of the most recommended solutions is Qualityze Supplier Quality Management Solution. It is a perfect fit for all the organizations who don’t want to miss improvement opportunities due to supplier failures. Most importantly, the organizations that believe in associating with suppliers for mutual benefit, which is much more than money.